Nanoformulations in Cancer: Focus on Patents and Clinical Trials.

In recent years, there has been a growing interest in incorporating patients’ perspectives when measuring and interpreting the clinical benefit of cancer therapies. Patient-reported outcomes (PROs) are used in a variety of cancer clinical trials. These studies range from using PROs to better understand the burden of cancer and the adverse effects of cancer therapy (such as pain), to studies that use PROs as the primary end point of the clinical trial, such as reducing symptoms like nausea or fatigue that can be caused by certain cancer therapies. The evolution of PROs in cancer trials has been recently documented by the National Cancer Institute (NCI)–supported Cancer Outcomes Measurement Working Group and by the US Food and Drug Administration’s recent guidance for the use of PROs in product labeling. PRO research also has been recognized as an important element in the NCI strategic planning process. A major NCI goal is to support research that enhances our understanding of the burden of disease among patients with cancer and cancer survivors, and reduces the sequellae of cancer throughout the continuum of care. NCI has taken an important role in developing new ways to measure patient-reported symptoms such as pain and fatigue, and aspects of health-related quality of life across a wide range of cancers and other diseases, through the Patient Reported Outcomes Measurement Information System (PROMIS). As a National Institutes of Health Roadmap initiative, PROMIS will provide clinical research communities with a reliable, valid, and standardized approach to capture these clinically relevant, but subjective and difficult-to-measure outcomes in clinical trials. Standardization of these data will provide additional benefits to the cancer clinical trial enterprise because it will eventually facilitate their incorporation into the cancer bioinformatics grid (ca-BIG), thereby making PROs available to all researchers who participate in and use the grid to support correlative research studies in connection with clinical trials. Through the NCI Clinical Trials Working Group (CTWG), NCI also has undertaken a major reassessment of the design, review, funding, and implementation of cancer clinical treatment trials and symptom management trials. Among the many recommendations contained in the CTWG report are ones to establish a new funding mechanism and prioritization process for supporting correlative science and quality-of-life studies using PROs, that can be initiated in association with clinical trials. As part of the CTWG process, NCI recently created a Symptom Management and Health-Related Quality of Life (SxQOL) Steering Committee to prioritize and review studies that include PROs as primary end points in symptom management clinical trials, and PROs as secondary end points in phase III Cooperative Group cancer treatment trials sponsored by the NCI. In addition, the SxQOL committee will provide guidance on how to improve the utility of PROs in cancer treatment trials and in symptom management trials. Although PRO data have potential utility for a variety of analyses in cancer clinical trials, the issues surrounding their appropriate and effective application are complex. In September 2006, the NCI convened a 2-day conference entitled “PatientReported Outcomes Assessment in Cancer Trials (PROACT): Evaluating and Enhancing the Payoff to Decision-Making.” This conference was cosponsored by the American Cancer Society and represented a collaborative effort among the leadership from all major NCI extramural divisions involved with clinical trials—the Division of Cancer Treatment and Diagnosis, the Division of Cancer Prevention, and the Division of Cancer Control and Population Sciences. The goal of the PROACT conference was to bring together scientists working in this area to inform NCI and the broader cancer research and policy community on how the NCI clinical trial infrastructure is currently organized to support PRO research in clinical trials, and to identify the issues and lessons learned from the experiences of NCI-sponsored cooperative groups and Community Cancer Oncology Programs; other national and international researchers; and US pharmaceutical industry experts in using PROs in phase II and III cancer treatment trials, as well as in symptom management trials. Before the conference, NCI charged a multidisciplinary Scientific Program Committee of internationally recognized experts to identify key determinants of the successful application of PROs in JOURNAL OF CLINICAL ONCOLOGY O V E R V I E W VOLUME 25 NUMBER 32 NOVEMBER 1

Background: Despite advances in cancer screening and therapeutics, persistent barriers to equitable cancer care and clinical trial access remain for underrepresented populations, including racial and ethnic minorities, non-English speaking patients, Medicaid recipients, elderly patients, and younger patients. Clinical trial enrollment remains disproportionately low among these groups, and trial participants often do not reflect the current demographics of the United States. While artificial intelligence (AI) tools have improved clinical trial patient matching, multiple barriers continue to limit trial participation. Addressing these barriers is essential to improve clinical trial representation. Methods: We developed a three-phase prospective pilot project at a large academic cancer center titled IMPACCT (Improving Participation in Cancer Clinical Trials) to improve clinical trial representation among breast and GI cancer patients. The project integrates community engagement, provider education, and evaluation of outcomes. Phase I - To build community trust, we established a multidisciplinary team of investigators, two community research fellows, and breast cancer survivors with prior trial experience. Outreach included collaborations with local businesses, event sponsorships, and support from the Yale Center for Community Engagement and Health Equity (CEHE) and the Community Research Fellow (CRF) program to sustain advisory boards and partnerships. Phase II - Providers on the breast and GI oncology teams completed “Just Ask,” an implicit bias training developed by ASCO and ACCC. This curriculum included six e-learning modules on diversity, equity, and strategies to improve inclusive trial recruitment. The training served as the primary intervention. Phase III - Post-training evaluation included provider and patient surveys. Providers completed surveys assessing perceived barriers to offering trials, while eligible patients completed surveys evaluating motivations and perceived barriers to trial participation. Additional metrics include trial offer rates, eligibility screening, and enrollment rates among underrepresented populations, categorized by care coordination, patient experience, and provider experience. We will also evaluate pre/post screening rates. Results: The “Just Ask” training intervention was implemented in January 2025. In the six months prior to the intervention, the breast cancer program enrolled 41 patients in clinical trials. In the six months following the intervention, enrollment increased to 75 patients as of June 2025. A total of 31 providers participated in the training, including 20 from the breast medical oncology group (14 medical oncologists, 2 surgical oncologists, 1 radiation oncologist, and 3 radiologists) and 11 from the gastrointestinal oncology group (9 medical oncologists, 1 colorectal surgeon, and 1 radiologist). To date, 14 of the 31 participating providers have completed consent for Phase III of the study, and 7 have completed post-intervention surveys. Conclusion: The IMPACCT project demonstrates early feasibility and promising signals of impact using the “Just Ask” intervention to improve clinical trial enrollment. The integration of community-based participatory research has proven both practical and effective, strengthening engagement between the cancer center and the community. These early findings suggest the intervention may be scalable across cancer types and clinical settings, with potential to inform broader equity-focused recruitment strategies in oncology trials. Citation Format: M. Taylor, M. Stefanou, G. Gong, M. Lustberg, A. Silber. Early Outcomes from the IMPACCT Project (Improving Participation in Cancer Clinical Trials): An Intervention to Improve Clinical Trial Participation Among Underrepresented Cancer Patients [abstract]. In: Proceedings of the San Antonio Breast Cancer Symposium 2025; 2025 Dec 9-12; San Antonio, TX. Philadelphia (PA): AACR; Clin Cancer Res 2026;32(4 Suppl):Abstract nr PD1-04.

Despite efforts to ameliorate disparities in cancer care and clinical trials, barriers persist. As part of a multiphase community-engaged assessment, an exploratory community-engaged research partnership, forged between an academic hospital and a community-based organization, set out to explore perceptions of cancer care and cancer clinical trials by black Bostonians. Key informant interviews with health care providers and patient advocates in community health centers (CHCs), organizers from grassroots coalitions focused on cancer, informed the development of a focus group protocol. Six focus groups were conducted with black residents in Boston, including groups of cancer survivors and family members. Transcripts were coded thematically and a code-based report was generated and analyzed by community and academic stakeholders. While some participants identified clinical trials as beneficial, overall perceptions conjured feelings of fear and exploitation. Participants describe barriers to clinical trial participation in the context of cancer care experiences, which included negative interactions with providers and mistrust. Primary care physicians (PCPs) reported being levied as a trusted resource for patients undergoing care, but lamented the absence of a mechanism by which to gain information about cancer care and clinical trials. Confusion about cancer care and clinical trials persists, even among individuals who have undergone treatment for cancer. Greater coordination between PCPs and CHC care teams and oncology care teams may improve patient experiences with cancer care, while also serving as a mechanism to disseminate information about treatment options and clinical trials. Inequities in cancer care and clinical trial participation persist. The findings of this study indicate that greater coordination with primary care physicians (PCPs) and community health center (CHC) providers may be an important step for both improving the quality of cancer care in communities and increasing awareness of clinical trials. However, PCPs and CHCs are often stretched to capacity with caring for their communities. This leaves the oncology community well positioned to create programs to bridge the communication gaps and provide resources necessary to support oncologic care along the cancer continuum, from prevention through survivorship.

Objective Nanodelivery is a modern technology involving improved delivery methods and drug formulations. The current development and initial applications of nanocarriers are pointing to new directions in the current development of nanomedicine. Researchers are increasingly applying nanodelivery to the delivery of therapeutic or diagnostic agents. This article discusses the preparation and application of nanocomplexes and nanoparticles, as well as their potential future value in clinical research. Through a review and analysis, it is hoped that this will serve as a guide for the future development of various nanodelivery technologies and help researchers learn more about these technologies. Materials and Methods A literature search was conducted using the keywords “Nano drug delivery” or “Nanomedical materials” or “Nano”. A literature search was conducted in three major databases, PubMed, Web of Science, and Google Scholar, using the keywords such as “Nano drug delivery”, “Nanomedical materials”, or “Nanobubble drug delivery”. The initial search was screened by title and abstract. In the full-text review, the titles or abstracts were reviewed according to the selection criteria based on the inclusion criteria. The risk of bias and study quality was assessed according to the Cochrane guidelines, and possible biases such as selection bias and good selection bias were included in the review. Results A total of 297 studies were included in this study, of which 219 were excluded based on the screening criteria, resulting in the inclusion of 78 studies, the majority of which were original studies and clinical trials, and a small number of which provided design and route of administration analysis of nanomaterial particles and effect fluorograms and were studied in more depth. This paper summarises and reviews the views and directions of the included articles. The main directions include cyclodextrin-based or grafted cyclodextrin nanomaterials, nanobubbles, and stimuli-sensitive and temperature-sensitive nanodelivery systems. Conclusion The use of innovative, targeted drug delivery systems is effective in cancer drug delivery by summarising the previous studies. However, nanodelivery systems' risks and therapeutic effects need to be evaluated before clinical application. Future research in the field of targeted drug delivery nanosystems should focus on the development of nanocarriers with high in vivo delivery capacity, good synergy with therapeutic agents, and milder short-term and long-term toxicological effects and conduct comprehensive preclinical trials on nanodrug delivery systems with high potential for clinical application as soon as possible, to find nanodrug delivery systems suitable for clinical use and put them into the clinical application as soon as possible.

Background: African Americans (AA) populations are among the most impacted by different types of cancers in the U.S. compared to other racial/ethnic groups. Among them, cancer clinical trials enrollment rates continue to be disproportionally low. Whites/Caucasian individuals comprise about 67% of the US population although having a 75% enrollment rate in clinical trials. Black/AA individuals comprise 13.4% of the US population although having a clinical trial enrollment rate of less than 5%. Participation of African Americans and African Nationals (AN) will significantly increase the state of knowledge regarding cancer treatment, survival, behavioral and pharmaceutical therapeutics, precision medicine, and increase access to the newest cancer therapies and can help improve cancer outcomes. Therefore, improving clinical trial participation among AA/AN patients is fundamental to reduce cancer health disparities. However more culturally focused information is needed addressing barrriers to clinical trials participation in these groups. Methods: We conducted 6 focus groups with 42 participants and two Town hall meetings with 120 participants targeted to AA/AN communities, where we gathered information about barriers to participation in research and clinical trials. We also reached out to 48 Black churches to discuss partnerships for dissemination and listen to concerns regarding AA participation in research. We leveraged our experience at USC NCCC where we have seen an increase of 147% in AA participation in clinical trials since 2015. Utilizing lessons learned and strategies identified we developed an AA/AN Clinical Trials Toolkit for CT outreach to inform about CT enrollment in Los Angeles County. The manual was culturally adapted to convey messages on clinical trials, using infographics and educational videos by cancer researchers, guided by persons living with cancer and other key stakeholders. Results: More than 160 stakeholders provided information in the creation of the AA/AN manual to include pastors, and other additional stakeholders. The manual was culturally adapted to convey lay messages on clinical trials addressing barriers to participation, using infographics and educational videos by cancer researchers. We found that partnering with pastors in the faith-based community was one of the most trusted ways of approaching this topic in the AA/AN community. Once the AA/AN manual was developed, stakeholders were asked to contribute to community wide dissemination and uptake. To date (6/6/2022), 62 churches in Los Angeles County serving AA/AN communities have been provided with a virtual copy of the Clinical Trials manual to be disseminated among their communities. The manual was launched and widely disseminated between November and March of 2022 and is currently available for public use. Our Tool Kit can be downloaded for free here: https://tinyurl.com/yey9hjpa Citation Format: Carolina Aristizabal, Fern Webb, Sandra Suther, Eduardo Ibarra, Cynthia Quince, Rosa Barahona, Mariana C. Stern, Lourdes A. Baezconde-Garbanati. Addressing cancer clinical trials lack of enrollment among African Americans and African Nationals [abstract]. In: Proceedings of the 15th AACR Conference on the Science of Cancer Health Disparities in Racial/Ethnic Minorities and the Medically Underserved; 2022 Sep 16-19; Philadelphia, PA. Philadelphia (PA): AACR; Cancer Epidemiol Biomarkers Prev 2022;31(1 Suppl):Abstract nr B016.

Database linkage between cancer registries and clinical trial consortia has the potential to elucidate referral patterns of children and adolescents with newly diagnosed cancer, including enrollment into cancer clinical trials. This study's primary objective was to assess the feasibility of this linkage approach. Patients younger than 20 years diagnosed with incident cancer during 2012-2017 in the Kentucky Cancer Registry (KCR) were linked with patients enrolled in a Children's Oncology Group (COG) study. Matched patients between databases were described by sex, age, race and ethnicity, geographical location when diagnosed, and cancer type. Logistic regression modeling identified factors associated with COG study enrollment. Timeliness of patient identification by KCR was reported through the Centers for Disease Control and Prevention's Early Case Capture (ECC) program. Of 1,357 patients reported to KCR, 47% were determined by matching to be enrolled in a COG study. Patients had greater odds of enrollment if they were age 0-4 years (v 15-19 years), reported from a COG-affiliated institution, and had renal cancer, neuroblastoma, or leukemia. Patients had lower odds of enrollment if Hispanic (v non-Hispanic White) or had epithelial (eg, thyroid, melanoma) cancer. Most (59%) patients were reported to KCR within 10 days of pathologic diagnosis. Linkage of clinical trial data with cancer registries is a feasible approach for tracking patient referral and clinical trial enrollment patterns. Adolescents had lower enrollment compared with younger age groups, independent of cancer type. Population-based early case capture could guide interventions designed to increase cancer clinical trial enrollment.

Many forms of cancer lack efficacious treatments, despite continuing advances in our understanding of molecular biology, and the development of precisely targeted agents that exploit relevant drivers and pathways of malignancy. To date the effectiveness of most tumor cell-focused molecularly targeted agents, in terms of event free and overall survival appears to be modest [1]. What is more, these new drugs come with a high price tag as companies seek to recoup development costs and to generate a return on investment (in part a consequence of a high attrition rate in oncological drug development, high regulatory burdens and expensive clinical trial costs) [2]. In the developing economies of the world, where cancer incidence is rising, the problems of unmet patient need is exacerbated by these high costs, putting many cancer treatments out of reach of patients and imposing strains on local health systems [3]. An alternative approach to seeking new drug treatments for cancer is not to start with molecular targets in mind, but to assess those drugs – approved for any indication – in our existing armamentarium which show some evidence of anticancer activity. This is the field of drug repurposing in oncology and there is now an increasing interest in the use of non-cancer drugs as anticancer therapeutics. There are two main advantages of repurposing. Firstly, by starting with well-known and well-characterized drugs we can draw on existing and detailed knowledge of pharmacodynamics, pharmacokinetics, bioavailability, toxicities, established protocols and dosing. This body of knowledge is far in excess of what can be gained in early phase clinical trials of new agents, particularly for first in class drugs. This is not to say that repurposed drugs do not need Phase I trials, since they may be used for cancer in schedules and combinations that differ from their accepted use, but it does represent a considerable short-circuiting of the preclinical phase of the drug d evelopment life cycle [4]. Secondly, many of the candidate drugs for repurposing are available at low cost; indeed many are available as generics. This is in stark contrast to the very high costs associated with the newest agents emerging from current pharmaceutical pipelines.

Timely Completion of Scientifically Rigorous Cancer Clinical Trials: An Unfulfilled Priority

40 Background: Continued smoking after a diagnosis of cancer negatively impacts cancer outcomes but the impact of tobacco on many innovative treatments has not yet been well established. Collecting and evaluating tobacco use in cancer clinical trials may advance understanding of the consequences of tobacco use on specific treatment modalities. We performed a systematic scoping review of the frequency of reporting and analysis of tobacco use in clinical trials run by cancer cooperative clinical trial groups. Methods: A comprehensive literature search was conducted to identify cancer cooperative group clinical trials published from January 2017 to October 2019 using Medline, Epub Ahead of Print and In-Process & Other Non-Indexed Citations, Embase, Cochrane Central Register of Controlled Trials using OvidSP. Eligible studies evaluated either systemic and/or radiation therapies, involved at least one cancer cooperative group, included > 100 adult patients and reported on at least one primary or secondary endpoint, which included overall survival (OS), disease/progression-free survival (DFS/PFS), response rates, toxicities/adverse events, or quality of life (QoL). Secondary analyses of previously published trials were excluded. Results: Among 14843 identified studies, 91 studies representing 90 trials met inclusion criteria. 24% were phase II trials, 2% phase II/III and 74% phase III. Trial start dates ranged from 1995-2015 with most (29%) between 2007-2008; median trial sample size was 406 (range: 100-4994); 86% involved systematic therapy, 35% involved radiation; 14% were lung and 5% were head and neck trials. 51% of trials had a curative intent, 33% were palliative and 16% involved hematologic cancers. 74 studies reported on OS, 73 DFS/PFS, and 88 toxicity/QoL. 19 studies reported baseline tobacco use information, while two reported collecting follow-up tobacco use. Of those collecting baseline tobacco use, only 7 reported any analysis of the impact of tobacco on clinical outcomes. There was significant heterogeneity in the reporting of baseline tobacco use: 5 reported never/ever status, 10 reported never/ex-smoker/current smoker status; 4 reported some measure of smoking intensity; none reported on verifying smoking status or second hand smoke exposure. Trials of tobacco related (lung and head and neck) cancers were more likely to report baseline tobacco use compared to non-tobacco related cancers (83% vs 6% p < 0.001). Conclusions: Few cancer cooperative group clinical trials report and analyze trial participants’ baseline tobacco use, and even fewer collect follow up information. Significant heterogeneity exists in reporting tobacco use. Routine standardized collection and reporting of tobacco use, both at baseline and follow up in clinical trials, should be implemented to enable investigators to evaluate the clinical impact of tobacco use on new cancer therapies.

Vitamin C has been a subject of interest in cancer therapy due to its potential effects on cancer cells and the immune system. This review explores the role of vitamin C in cancer therapy, focusing on clinical trials and its efficacy. The review includes a discussion of the clinical trials on vitamin C in cancer therapy. Other results showed no significant difference in cancer prevalence between the intervention and control groups, suggesting that vitamin C intake did not affect cancer incidence. The study found that high-dose intravenous vitamin C in combination with chemotherapy and radiation therapy was safe and well-tolerated, with no significant adverse effects. However, the study did not show a significant effect on overall survival or progression-free survival. Despite the lack of significant results in clinical trials, there is evidence to support the use of vitamin C as an adjuvant in cancer therapy. Vitamin C has been shown to have anti-tumor effects, including the creation of reactive oxygen species (ROS) that directly have cytotoxic activity on cancer cells. Additionally, vitamin C can create important epigenetic changes due to its effect on 2-oxoglutarate-like histone and DNA de-methylated. In preclinical studies, vitamin C has been shown to have a synergetic effect with some types of chemotherapy and radiation therapy. Additionally, vitamin C has been shown to stimulate the production and activation of immune cells, such as T-lymphocytes and natural killer cells, which have a function in fighting against pathogens and cancer cells. In conclusion, while clinical trials have not shown significant effects of vitamin C on cancer prevention or therapy, there is evidence to support the use of vitamin C as an adjuvant in cancer therapy. Further research is needed to determine the optimal dose and route of administration of vitamin C in cancer therapy.

Cancer is the top cause of death in Taiwan. Cancer clinical trials are crucial for developing new treatments. Understanding the motivations and barriers related to the factors of influence on patient decisions regarding participation in cancer clinical trials may help clinical researchers improve patients' understanding of clinical trials and improve their ability to make autonomous decisions regarding informed consent. This study was designed to explore the factors affecting patient decisions regarding cancer clinical trial participation using a systematic review of the literature. A systematic review was used. Articles were retrieved from electronic databases including Cochrane Library, Embase, PubMed, CINAHLE, and Scopus. The following keywords and MeSH terms were used to search for articles on cancer, clinical trials, participation, factors or motivations, and decision making. A total of 9353 articles published from 2011 to January 2021 that matched the search criteria were extracted. After screening the topics, deleting repetitions, and doing critical appraisals, 40 articles were selected for analysis. Research quality was assessed using Joanna Briggs Institute Levels of Evidence criteria. Eight motivations and nine barriers were found to significantly influence patient participation in cancer clinical trials. These motivations were: (1) trust in health professionals, (2) hope for therapeutic benefits, (3) the last treatment option, (4) altruism, (5) family support, (6) extra care, (7) patients' or others' past therapy experience, and (8) other demographic factors. The barriers to participation identified were: (1) fear of side effects or treatment efficacy, (2) concerns about trial requirements and randomization, (3) heavy financial burden, (4) inability to maintain quality of life, (5) inability to participate due to disease progression, (6) having treatment preferences, (7) health professionals' negative attitudes toward clinical trials, (8) family opposition, and (9) providing trial information at an inappropriate time. Eight motivational factors and nine barriers influencing patient decisions regarding cancer clinical trial participation were extracted from the selected articles. In addition to personal and situational factors, family and health professionals were found to influence patient decisions regarding cancer clinical trial participation. The authors hope that the findings of this study help clinical researchers further improve patient understanding of clinical trials and help patients make autonomous decisions with regard to informed consent.

Disparities in minorities' representation in cancer clinical trials have been shown only in adult populations, which suggest that the main causes of these disparities relate to health system-based barriers, including issues of poverty (lack of insurance), poor access to trials, and an inadequate number of clinical trials. Initiatives that increase the participation of community physicians in cancer clinical research trials and increase low socioeconomic status patients' access to cancer trials will likely ameliorate this problem.

Enrollment rates onto cancer clinical trials are low and reflect a small subset of the population of which even fewer participants come from populations of racial or ethnic diversity or low socioeconomic status. There is a need to increase enrollment onto cancer clinical trials with a focus on recruitment of a diverse, underrepresented patient population. To use the electronic medical record (EMR) to understand the eligibility and enrollment rates for all available cancer trials in the ambulatory care setting at an urban safety net hospital to identify specific strategies for enhanced accrual onto cancer clinical trials of diverse and underserved patients. A clinical trial screening note was created for the EMR by the clinical trials office at an urban safety net hospital. 847 cancer clinical trial screening notes were extracted from the EMR between January 1, 2010 and December 31, 2010. During that time, 99 cancer trials were registered for accrual, including clinical treatment, survey, data repository, imaging, and symptom management trials. Data on eligibility, enrollment status, and relationship to sociodemographic status were compared. This is a single-institution and retrospective study. The findings demonstrate that a formal process of tracking cancer clinical trial screens using an EMR can document baseline rates of institution-specific accrual patterns and identify targeted strategies for increasing cancer clinical trial enrollment among a vulnerable patient population. Offering nontreatment trials may be an important and strategic method of engaging this vulnerable population in clinical research.

Cancer continues to pose a significant global health challenge, as evidenced by the increasing incidence rates and high mortality rates, despite the advancements made in chemotherapy. The emergence of chemoresistance further complicates the effectiveness of treatment. However, there is growing interest in the potential of metformin, a commonly prescribed drug for type 2 diabetes mellitus (T2DM), as an adjuvant chemotherapy agent in cancer treatment. Although the precise mechanism of action of metformin in cancer therapy is not fully understood, it has been found to have pleiotropic effects, including the modulation of metabolic pathways, reduction in inflammation, and the regulation of cellular proliferation. This comprehensive review examines the anticancer properties of metformin, drawing insights from various studies conducted in vitro and in vivo, as well as from clinical trials and observational research. This review discusses the mechanisms of action involving both insulin-dependent and independent pathways, shedding light on the potential of metformin as a therapeutic agent for different types of cancer. Despite promising findings, there are challenges that need to be addressed, such as conflicting outcomes in clinical trials, considerations regarding dosing, and the development of resistance. These challenges highlight the importance of further research to fully harness the therapeutic potential of metformin in cancer treatment. The aims of this review are to provide a contemporary understanding of the role of metformin in cancer therapy and identify areas for future exploration in the pursuit of effective anticancer strategies.

Cancer clinical trials are a source for high-quality cancer care. However, they are often perceived as an option of last resort. Raising consciousness about cancer clinical trials in community settings may lead to informed decision-making about cancer clinical trials. Objective: To modify and pilot training materials for a community organization intervention to positively impact knowledge, attitudes, beliefs, and behaviors regarding cancer research in African American communities in North Carolina. Methodology: The Education Network to Advance Cancer Clinical Trials, University of North Carolina at Chapel Hill, and four community-based organizations collaborated using CBPR methods to revise cancer clinical trials education materials for Southern African American communities. Three cancer clinical trials education modules were developed and piloted in African American Communities with 128 participatnts. Modules include: 1) a workshop about cancer clinical trials and what they mean for communities; 2) a storytelling discussion describing one person's experience with cancer clinical trials; and 3) a discussion session that reviews the myths and facts about cancer clinical trials. Results/Impact: This presentation describes the preliminary findings of the intervention. Participants demonstrated understanding of the definition of clinical trials. Preliminary results establish consensus that participants desire equal access to cancer clinical trials, improved community education, and personal interest in learning more about clinical trials. Conclusions: Culturally sensitive community education sessions about cancer clinical trials improve favorable attitudes towards clinical trials. Actively engaging African American communities in dialogue about cancer research is necessary to create community awareness of the role of cancer research in reducing health disparities. Engaging community partners in cancer clinical trials education is synergistic with their mission of equal access to care. Citation Information: Cancer Epidemiol Biomarkers Prev 2010;19(10 Suppl):B20.