title: Sipjeondaebo-tang in patients with cancer with anorexia: a protocol for a pilot, randomised, controlled trial.
abstract: Cancer-related anorexia is the loss of appetite or desire to eat in patients with cancer. Although treatments for cancer-related anorexia do exist, patients have sought complementary and alternative medicine including herbal remedies, due to safety concerns. Sipjeondaebo-tang is one among other popular herbal medicines that are beneficial to management of anorexia in Korea. The purpose of this study is to examine the feasibility for a full randomised clinical trial of Sipjeondaebo-tang for cancer-related anorexia.
  
  
  
  This study is a randomised, double-blinded and placebo-controlled trial of Sipjeondaebo-tang. For the study, 40 patients with cancer, aged 20-80 years, who reported anorexia, will be recruited. The participants will receive either 3 g of Sipjeondaebo-tang or a placebo, 3 times a day for 4 weeks. The primary end point is a change in the anorexia/cachexia subscale (A/CS) of Functional Assessment of Anorexia/Cachexia Therapy (FAACT). The secondary end points include changes in the visual analogue scale (VAS) of appetite, cortisol and ghrelin. The outcomes will be measured on every visit. Each participant will visit once a week during 4 weeks.
  
  
  
  The present study has been approved by the Institutional Review Board of the Dunsan Korean Medicine Hospital of Daejeon University (reference DJDSKH-15-03-2 (V.2.0)). The results will be disseminated in a peer-reviewed journal and scientific conference.
  
  
  
  NCT02468141; Pre-results.
authors.affiliation: Department of Korean Preventive Medicine, Graduate School, Kyung Hee University, Seoul, Republic of Korea.
authors.forename: Chunhoo
authors.initials: C
authors.lastname: Cheon
authors.affiliation: Department of Preventive Medicine, College of Korean Medicine, Daejeon University, Daejeon, Republic of Korea.
authors.forename: Sunju
authors.initials: S
authors.lastname: Park
authors.affiliation: Department of Korean Preventive Medicine, Graduate School, Kyung Hee University, Seoul, Republic of Korea.
authors.forename: Yu Lee
authors.initials: YL
authors.lastname: Park
authors.affiliation: Department of Korean Preventive Medicine, Graduate School, Kyung Hee University, Seoul, Republic of Korea.
authors.forename: Ching-Wen
authors.initials: CW
authors.lastname: Huang
authors.affiliation: Department of Korean Preventive Medicine, Graduate School, Kyung Hee University, Seoul, Republic of Korea.
authors.forename: Youme
authors.initials: Y
authors.lastname: Ko
authors.affiliation: Department of Korean Preventive Medicine, Graduate School, Kyung Hee University, Seoul, Republic of Korea.
authors.forename: Bo-Hyoung
authors.initials: BH
authors.lastname: Jang
authors.affiliation: Department of Korean Preventive Medicine, Graduate School, Kyung Hee University, Seoul, Republic of Korea.
authors.forename: Yong-Cheol
authors.initials: YC
authors.lastname: Shin
authors.affiliation: Department of Korean Preventive Medicine, Graduate School, Kyung Hee University, Seoul, Republic of Korea.
authors.forename: Seong-Gyu
authors.initials: SG
authors.lastname: Ko
mesh_terms: D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D000855:Anorexia / Q000188:drug therapy* / Q000209:etiology*; D001066:Appetite / Q000187:drug effects; D004311:Double-Blind Method; D005240:Feasibility Studies; D005260:Female; D054439:Ghrelin / Q000097:blood; D006801:Humans; D006854:Hydrocortisone / Q000097:blood; D008297:Male; D008875:Middle Aged; D009369:Neoplasms / Q000150:complications*; D010865:Pilot Projects; D010936:Plant Extracts / Q000009:adverse effects / Q000627:therapeutic use*; D012107:Research Design; D012720:Severity of Illness Index; D055815:Young Adult
chemical_list: D054439:Ghrelin; D010936:Plant Extracts; C574032:sipjundaebo-tang; D006854:Hydrocortisone
keywords: COMPLEMENTARY MEDICINE