Efficacy of active hexose correlated compound on survival of patients with resectable/borderline resectable pancreatic cancer: a study protocol for a double-blind randomized phase II study

Trials

Satoshi Hirano¹  Yasuhiro Kodera²  Suguru Yamada³  Akihiko Tsuchida⁴  Kiichi Hirota⁵  Hideki Ishikawa⁶  Tsutomu Fujii⁷  Kenichiro Uemura⁸  Daisuke Hashimoto⁹  Sohei Satoi⁹  Mitsugu Sekimoto⁹  Tomohisa Yamamoto⁹  Keiko Kamei^1,10 

[1] Department of Gastroenterological Surgery II, Hokkaido University Faculty of Medicine;Department of Gastroenterological Surgery, Nagoya University Graduate School of Medicine;Department of Gastrointestinal and Pediatric Surgery, Nagoya Central Hospital;Department of Gastrointestinal and Pediatric Surgery, Tokyo Medical University;Department of Human Stress Response Science, Institute of Biomedical Science, Kansai Medical University;Department of Molecular-Targeting Cancer Prevention, Graduate School of Medical Science, Kyoto Prefectural University of Medicine;Department of Surgery and Science, Faculty of Medicine, Academic Assembly, University of Toyama;Department of Surgery, Institute of Biomedical and Health Sciences, Hiroshima University;Department of Surgery, Kansai Medical University;Department of Surgery, Kindai University Faculty of Medicine;

关键词: Active hexose correlated compound;    Functional food;    Pancreatic cancer;    Chemotherapy;    Operation;   

DOI  :  10.1186/s13063-021-05934-x

来源: DOAJ

【 摘 要 】

Abstract Background The prognosis of pancreatic ductal adenocarcinoma remains very poor. One possible reason for the short survival of patients with this disease is malnutrition, which can be present at the initial diagnosis, and continue after pancreatectomy. Then, it is important to improve nutritional status and to decrease adverse events during neoadjuvant and adjuvant chemotherapy. Active hexose correlated compound (AHCC) is a standardized extract of cultured Lentinula edodes mycelia, and is considered a potent biological response modifier in the treatment of cancer. To evaluate the survival impact of AHCC on the patients with pancreatic ductal adenocarcinoma, we plan to perform this trial. Methods This is a prospective multicenter phase II trial in patients with resectable/borderline resectable pancreatic ductal adenocarcinoma to investigate the efficacy of AHCC regarding survival. Patients will begin taking AHCC or placebo on the first day of neoadjuvant therapy. AHCC or placebo will be continued until 2 years after surgery. The primary endpoint will be 2-year disease-free survival. The secondary endpoints are the completion rate, dose intensity, and adverse event profile of preoperative chemotherapy; response rate to preoperative chemotherapy; rate of decrease in tumor marker (carbohydrate antigen 19-9, carcinoembryonic antigen) concentrations during preoperative chemotherapy; entry rate, completion rate, dose intensity, and adverse event profile of adjuvant chemotherapy; safety of the protocol therapy (adverse effect of AHCC); 2-year overall survival rate; and nutrition score before and after preoperative chemotherapy, and before and after adjuvant chemotherapy. We will enroll 230 patients, and the study involves eight leading Japanese institutions that are all high-volume centers in pancreatic surgery. Discussion AHCC is expected to function as a supportive food in patients with pancreatic ductal adenocarcinoma, to reduce the proportion of severe adverse events related to neoadjuvant chemotherapy, and to increase the completion proportion of multimodal treatments, resulting in improved survival. Trial registration The trial protocol has been registered in the protocol registration system at the Japan Registry of Clinical Trials (Trial ID: jRCTs051200029 ). At the time of the submission of this paper (October 2020), the protocol version is 2.0. The completion date is estimated to be November 2024.

【 授权许可】

Unknown