PMID- 28430159 OWN - NLM STAT- MEDLINE DCOM- 20180216 LR - 20240109 IS - 1660-3397 (Electronic) IS - 1660-3397 (Linking) VI - 15 IP - 4 DP - 2017 Apr 21 TI - Efficacy of Low-Molecular-Weight Fucoidan as a Supplemental Therapy in Metastatic Colorectal Cancer Patients: A Double-Blind Randomized Controlled Trial. LID - 10.3390/md15040122 [doi] LID - 122 AB - BACKGROUND: Low-molecular-weight fucoidan (LMF) is widely used as a food supplement for cancer patients. However, all of the studies are in vitro or were conducted using mice. Therefore, powerful clinical evidence for LMF use is relatively weak. This study aimed to evaluate the efficacy of LMF as a supplemental therapy to chemo-target agents in metastatic colorectal cancer (mCRC) patients. METHODS: We conducted a prospective, randomized, double-blind, controlled trial to evaluate the efficacy of LMF as a supplemental therapy to chemotarget agents in patients with metastatic colorectal cancer (mCRC). Sixty eligible patients with mCRC were included. Finally, 54 patients were enrolled, of whom 28 were included in the study group and 26 in the control group. The primary endpoint was the disease control rate (DCR), and secondary endpoints included the overall response rate (ORR), progression-free survival (PFS), overall survival (OS), adverse effects (AEs), and quality of life (QOL). RESULTS: The DCRs were 92.8% and 69.2% in the study and control groups, respectively (p = 0.026), in a median follow-up period of 11.5 months. The OS, PFS, ORR, AEs, and QOL did not significantly differ between the two groups. CONCLUSION: This is the first clinical trial evaluating the efficacy of LMF as a supplemental therapy in the management of patients with mCRC. The results indicate that LMF combined with chemotarget agents significantly improved the DCR. FAU - Tsai, Hsiang-Lin AU - Tsai HL AD - Division of Colorectal Surgery, Department of Surgery, Kaohsiung Medical University Hospital, Kaohsiung Medical University, Kaohsiung 807, Taiwan. chunpin870132@yahoo.com.tw. AD - Department of Surgery, Faculty of Medicine, College of Medicine, Kaohsiung Medical University, Kaohsiung 807, Taiwan. chunpin870132@yahoo.com.tw. FAU - Tai, Chi-Jung AU - Tai CJ AD - Graduate Institute of Natural Product, College of Pharmacy, Kaohsiung Medical University, Kaohsiung 807, Taiwan. taichijung@gmail.com. AD - Department of Family Medicine, Pingtung Hospital, Ministry of Health and Welfare, Pingtung 928, Taiwan. taichijung@gmail.com. FAU - Huang, Ching-Wen AU - Huang CW AD - Division of Colorectal Surgery, Department of Surgery, Kaohsiung Medical University Hospital, Kaohsiung Medical University, Kaohsiung 807, Taiwan. baseball5824@yahoo.com.tw. AD - Department of Surgery, Faculty of Medicine, College of Medicine, Kaohsiung Medical University, Kaohsiung 807, Taiwan. baseball5824@yahoo.com.tw. FAU - Chang, Fang-Rong AU - Chang FR AD - Graduate Institute of Natural Product, College of Pharmacy, Kaohsiung Medical University, Kaohsiung 807, Taiwan. aaronfrc@kmu.edu.tw. FAU - Wang, Jaw-Yuan AU - Wang JY AD - Division of Colorectal Surgery, Department of Surgery, Kaohsiung Medical University Hospital, Kaohsiung Medical University, Kaohsiung 807, Taiwan. jawyuanwang@gmail.com. AD - Department of Surgery, Faculty of Medicine, College of Medicine, Kaohsiung Medical University, Kaohsiung 807, Taiwan. jawyuanwang@gmail.com. AD - Graduate Institute of Clinical Medicine, College of Medicine, Kaohsiung Medical University, Kaohsiung 807, Taiwan. jawyuanwang@gmail.com. AD - Center for Biomarkers and Biotech Drugs, College of Medicine, Kaohsiung Medical University, Kaohsiung 807, Taiwan. jawyuanwang@gmail.com. AD - Research Center for Environmental Medicine, College of Medicine, Kaohsiung Medical University, Kaohsiung 807, Taiwan. jawyuanwang@gmail.com. AD - Research Center for Natural Products & Drug Development, Kaohsiung Medical University, Kaohsiung 807, Taiwan. jawyuanwang@gmail.com. LA - eng PT - Journal Article PT - Randomized Controlled Trial DEP - 20170421 PL - Switzerland TA - Mar Drugs JT - Marine drugs JID - 101213729 RN - 0 (Antineoplastic Agents) RN - 0 (Polysaccharides) RN - 9072-19-9 (fucoidan) SB - IM MH - Adult MH - Aged MH - Aged, 80 and over MH - Antineoplastic Agents/*therapeutic use MH - Colorectal Neoplasms/*drug therapy MH - Dietary Supplements MH - Disease-Free Survival MH - Double-Blind Method MH - Female MH - Humans MH - Male MH - Middle Aged MH - Polysaccharides/*therapeutic use MH - Prospective Studies MH - Quality of Life PMC - PMC5408268 OTO - NOTNLM OT - disease control rate OT - low-molecular-weight fucoidan OT - metastatic colorectal cancer OT - supplemental therapy COIS- The authors declare no conflict of interest. EDAT- 2017/04/22 06:00 MHDA- 2018/02/17 06:00 PMCR- 2017/04/01 CRDT- 2017/04/22 06:00 PHST- 2017/03/24 00:00 [received] PHST- 2017/04/12 00:00 [revised] PHST- 2017/04/18 00:00 [accepted] PHST- 2017/04/22 06:00 [entrez] PHST- 2017/04/22 06:00 [pubmed] PHST- 2018/02/17 06:00 [medline] PHST- 2017/04/01 00:00 [pmc-release] AID - md15040122 [pii] AID - marinedrugs-15-00122 [pii] AID - 10.3390/md15040122 [doi] PST - epublish SO - Mar Drugs. 2017 Apr 21;15(4):122. doi: 10.3390/md15040122.