Orally Administrated JBM-TC4 Prevents Acute Radiodermatitis in Breast Cancer Patients

Summary

This trial is designed as a multicenter, double-blinded, randomized, placebo controlled study to assess the safety and efficacy of JBM-TC4 for the prevention and treatment of acute radiation-induced dermatitis in breast cancer patients receiving radiotherapy.

Timeline

Start

2014-11

Primary completion

2016-12

Completion

2016-12

Publications

• Background Chang HC, Huang YC, Hung WC. Antiproliferative and chemopreventive effects of adlay seed on lung cancer in vitro and in vivo. J Agric Food Chem. 2003 Jun 4;51(12):3656-60. doi: 10.1021/jf021142a.
• Background Chen HJ, Lo YC, Chiang W. Inhibitory effects of adlay bran (Coix lachryma-jobi L. var. ma-yuen Stapf) on chemical mediator release and cytokine production in rat basophilic leukemia cells. J Ethnopharmacol. 2012 May 7;141(1):119-27. doi: 10.1016/j.jep.2012.02.009. Epub 2012 Feb 14.
• Background Chung CP, Hsu CY, Lin JH, Kuo YH, Chiang W, Lin YL. Antiproliferative lactams and spiroenone from adlay bran in human breast cancer cell lines. J Agric Food Chem. 2011 Feb 23;59(4):1185-94. doi: 10.1021/jf104088x. Epub 2011 Feb 1.
• Background Chung CP, Hsia SM, Lee MY, Chen HJ, Cheng F, Chan LC, Kuo YH, Lin YL, Chiang W. Gastroprotective activities of adlay (Coix lachryma-jobi L. var. ma-yuen Stapf) on the growth of the stomach cancer AGS cell line and indomethacin-induced gastric ulcers. J Agric Food Chem. 2011 Jun 8;59(11):6025-33. doi: 10.1021/jf2009556. Epub 2011 May 5.
• Background Hung WC, Chang HC. Methanolic extract of adlay seed suppresses COX-2 expression of human lung cancer cells via inhibition of gene transcription. J Agric Food Chem. 2003 Dec 3;51(25):7333-7. doi: 10.1021/jf0340512.
• Background Kuo CC, Shih MC, Kuo YH, Chiang W. Antagonism of free-radical-induced damage of adlay seed and its antiproliferative effect in human histolytic lymphoma U937 monocytic cells. J Agric Food Chem. 2001 Mar;49(3):1564-70. doi: 10.1021/jf001215v.
• Background Kuo CC, Chen HH, Chiang W. Adlay ( yi yi; "soft-shelled job's tears"; the seeds of Coix lachryma-jobi L. var. ma-yuen Stapf) is a Potential Cancer Chemopreventive Agent toward Multistage Carcinogenesis Processes. J Tradit Complement Med. 2012 Oct;2(4):267-75. doi: 10.1016/s2225-4110(16)30112-2.
• Background Lee MY, Lin HY, Cheng F, Chiang W, Kuo YH. Isolation and characterization of new lactam compounds that inhibit lung and colon cancer cells from adlay (Coix lachryma-jobi L. var. ma-yuen Stapf) bran. Food Chem Toxicol. 2008 Jun;46(6):1933-9. doi: 10.1016/j.fct.2008.01.033. Epub 2008 Feb 12.
• Background Li SC, Chen CM, Lin SH, Chiang W, Shih CK. Effects of adlay bran and its ethanolic extract and residue on preneoplastic lesions of the colon in rats. J Sci Food Agric. 2011 Feb;91(3):547-52. doi: 10.1002/jsfa.4219. Epub 2010 Nov 19.
• Background Yao HT, Lin JH, Chiang MT, Chiang W, Luo MN, Lii CK. Suppressive effect of the ethanolic extract of adlay bran on cytochrome P-450 enzymes in rat liver and lungs. J Agric Food Chem. 2011 Apr 27;59(8):4306-14. doi: 10.1021/jf200117m. Epub 2011 Mar 18.
• Background Zhan YP, Huang XE, Cao J, Lu YY, Wu XY, Liu J, Xu X, Xiang J, Ye LH. Clinical safety and efficacy of Kanglaite(R) (Coix Seed Oil) injection combined with chemotherapy in treating patients with gastric cancer. Asian Pac J Cancer Prev. 2012;13(10):5319-21. doi: 10.7314/apjcp.2012.13.10.5319.

Drugs

Indications