The proposed research is a continuation of our ongoing randomized, double- blind skin cancer prevention trial initiated in 1985. The objective of the project is to complete the cancer prevention trial to compare the effectiveness of 13-cis retinoic acid (13-cRA) versus retinol (ROH) versus placebo in the prevention of basal cell cancer (BCC) and cutaneous squamous cell cancer (SCC) in subjects with a prior history of at least four of these lesions. The hypotheses to be evaluated include: 1) A supplement of 5-10 mg per day of 13-cRA will reduce the incidence of new BCC/SCC when compared to placebo. 2) A supplement of 25,000 IU retinol will reduce the incidence of new BCC/SCC when compared to placebo.
The specific aims of this trial include: 1) To randomize at least 498 eligible subjects to 13-cRA, ROH, or placebo. 2) To motivate and determine the frequency and degree of protocol compliance. 3) To determine the frequency, type, and degree of adverse or protective health events. 4) To compare the number, incidence rate, and the time to diagnosis of new skin cancers. 5) To determine plasma concentrations of ROH and retinyl palmitate for each subject's initial accrual visit and for selected subjects at their follow- up visits. 6) To collect and freeze plasma samples from subjects for future analyses of other nutrients. 7) To determine the effects of ROH and 13-cRA as immunomodulators or key cellular immune functions.
| Blohm-Mangone, Karen; Burkett, Nichole B; Tahsin, Shekha et al. (2018) Pharmacological TLR4 Antagonism Using Topical Resatorvid Blocks Solar UV-Induced Skin Tumorigenesis in SKH-1 Mice. Cancer Prev Res (Phila) 11:265-278 |
| Knights-Mitchell, Shellie S; Romanowski, Marek (2018) Near-Infrared Activated Release of Doxorubicin from Plasmon Resonant Liposomes. Nanotheranostics 2:295-305 |
| Roh, Eunmiri; Lee, Mee-Hyun; Zykova, Tatyana A et al. (2018) Targeting PRPK and TOPK for skin cancer prevention and therapy. Oncogene 37:5633-5647 |
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| Yamamoto, Hiroyuki; Ryu, Joohyun; Min, Eli et al. (2017) TRAF1 Is Critical for DMBA/Solar UVR-Induced Skin Carcinogenesis. J Invest Dermatol 137:1322-1332 |
| Zykova, Tatyana A; Zhu, Feng; Wang, Lei et al. (2017) The T-LAK Cell-originated Protein Kinase Signal Pathway Promotes Colorectal Cancer Metastasis. EBioMedicine 18:73-82 |
| Einspahr, Janine G; Curiel-Lewandrowski, Clara; Calvert, Valerie S et al. (2017) Protein activation mapping of human sun-protected epidermis after an acute dose of erythemic solar simulated light. NPJ Precis Oncol 1: |
| Gao, Ge; Zhang, Tianshun; Wang, Qiushi et al. (2017) ADA-07 Suppresses Solar Ultraviolet-Induced Skin Carcinogenesis by Directly Inhibiting TOPK. Mol Cancer Ther 16:1843-1854 |
| Glazer, Evan S; Bartels, Peter H; Lian, Fangru et al. (2016) Quantitative histopathology identifies patients with thin melanomas who are at risk for metastases. Melanoma Res 26:261-6 |
| Franklin, Stephen J; Younis, Usir S; Myrdal, Paul B (2016) Estimating the Aqueous Solubility of Pharmaceutical Hydrates. J Pharm Sci 105:1914-1919 |
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