This application represents the second competing renewal of the Comprehensive Cancer Center of Wake Forest University (CCCWFU) Community Clinical Oncology Program (CCOP) Research Base. At present, the Research Base has 11 participating CCOPs (including one Minority-Based CCOP) and 5 Prevention Members, with an additional eight CCOPs (including four MB CCOPs) who are in various stages of joining. The CCCWFU CCOP Research Base has three Specific Aims:
o Specific Aim 1 : To reduce cancer incidence and improve quality of life by providing high-quality cancer prevention and control clinical trials for the physicians, research nurses, clinical research professionals, and patients from participating CCOPs, Minority-Based CCOPs, and Prevention Members.
o Specific Aim 2 : To prevent or reduce the symptoms of cancer and its treatments by utilizing conventional pharmacologic agents, botanical and natural products, complementary and alternative therapies, and behavioral and/or educational interventions in open-label Phase II and randomized ( placebo-controlled) ( double-blind) Phase III clinical trials.
o Specific Aim 3 : To increase recruitment and retention on CCCWFU CCOP Research Base clinical trials, with a particular emphasis on under-represented populations including racial and ethnic minorities, women, adolescents, and the elderly. Cancer Control studies focus on symptom management (i.e., the symptoms of cancer and its treatments), which is divided into the areas of symptom prevention and symptom treatment. Symptom management research themes include cardiotoxicity, cognitive function and mood, fatigue, hot flashes, infections, the radiation-induced """"""""-itises"""""""" (cystitis, dermatitis, enteritis, esophagitis, and mucositis), sexual function, steroid toxicity, tobacco cessation, and weight-related issues (anorexia and weight loss;diet, exercise, and weight gain). Cancer prevention research is focused on primary and secondary chemoprevention studies utilizing dietary supplements as well as botanical and natural products, including fruit and vegetable extracts, vitamin D and its analogues, and fish oil.

National Institute of Health (NIH)
National Cancer Institute (NCI)
Cooperative Clinical Research--Cooperative Agreements (U10)
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Special Emphasis Panel (ZCA1-SRRB-3 (J1))
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Kelaghan, Joseph
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Wake Forest University Health Sciences
Schools of Medicine
United States
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Datta, Mridul; Shaw, Edward G; Lesser, Glenn J et al. (2017) A Randomized Double-Blind Placebo-Controlled Trial of Fruit and Vegetable Concentrates on Intermediate Biomarkers in Head and Neck Cancer. Integr Cancer Ther :1534735416684947
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Greven, Kathryn M; Case, L Douglas; Nycum, Lawrence R et al. (2015) Effect of ArginMax on sexual functioning and quality of life among female cancer survivors: results of the WFU CCOP Research Base Protocol 97106. J Community Support Oncol 13:87-94
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Spigel, David R; Ervin, Thomas J; Ramlau, Rodryg A et al. (2013) Randomized phase II trial of Onartuzumab in combination with erlotinib in patients with advanced non-small-cell lung cancer. J Clin Oncol 31:4105-14
O'Flaherty, Joseph T; Wooten, Rhonda E; Samuel, Michael P et al. (2013) Fatty acid metabolites in rapidly proliferating breast cancer. PLoS One 8:e63076
Vitolins, Mara Z; Griffin, Leah; Tomlinson, W Vic et al. (2013) Randomized trial to assess the impact of venlafaxine and soy protein on hot flashes and quality of life in men with prostate cancer. J Clin Oncol 31:4092-8
Lesser, Glenn J; Case, Doug; Stark, Nancy et al. (2013) A randomized, double-blind, placebo-controlled study of oral coenzyme Q10 to relieve self-reported treatment-related fatigue in newly diagnosed patients with breast cancer. J Support Oncol 11:31-42

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