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Randomized Controlled Trial
. 2016 May 12;6(5):e011212.
doi: 10.1136/bmjopen-2016-011212.

Sipjeondaebo-tang in patients with cancer with anorexia: a protocol for a pilot, randomised, controlled trial

Chunhoo Cheon  1 , Sunju Park  2 , Yu Lee Park  1 , Ching-Wen Huang  1 , Youme Ko  1 , Bo-Hyoung Jang  1 , Yong-Cheol Shin  1 , Seong-Gyu Ko  1
Affiliations
Randomized Controlled Trial

Sipjeondaebo-tang in patients with cancer with anorexia: a protocol for a pilot, randomised, controlled trial

Chunhoo Cheon et al. BMJ Open. .

Abstract

Introduction: 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.

Methods and analysis: 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.

Ethics and dissemination: 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.

Trial registration number: NCT02468141; Pre-results.

Keywords: COMPLEMENTARY MEDICINE.

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Figures

Figure 1
Figure 1
Study flow chart. SJDBT, Sipjeondaebo-tang.
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References

    1. Fearon K, Strasser F, Anker SD et al. . Definition and classification of cancer cachexia: an international consensus. Lancet Oncol 2011;12:489–95. 10.1016/S1470-2045(10)70218-7 - DOI - PubMed
    1. Bruera E. Clinical management of anorexia and cachexia in patients with advanced cancer. Oncology 1992;49(Suppl 2):35–42. 10.1159/000227126 - DOI - PubMed
    1. Dewys WD, Begg C, Lavin PT et al. . Prognostic effect of weight loss prior to chemotherapy in cancer patients. Eastern Cooperative Oncology Group. Am J Med 1980;69:491–7. - PubMed
    1. Del Fabbro E. Current and future care of patients with the cancer anorexia-cachexia syndrome. Am Soc Clin Oncol Educ Book 2015;35:e229–37. 10.14694/EdBook_AM.2015.35.e229 - DOI - PubMed
    1. Yavuzsen T, Davis MP, Walsh D et al. . Systematic review of the treatment of cancer-associated anorexia and weight loss. J Clin Oncol 2005;23:8500–11. 10.1200/JCO.2005.01.8010 - DOI - PubMed

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