A randomized controlled trial of betamethasone on fatigue in patients with advanced cancer.

Fatigue is one of the most uncomfortable physical symptoms seen in patients with advanced cancer. Previous studies have reported on the efficacy of corticosteroids from Western countries. To assess the effectiveness of 4mg betamethasone improving fatigue among Japanese patients with advanced cancer. A randomized, double-blind, placebo-controlled trial enrolled eligible patients with advanced cancer expected to survive 1-2 months, with an Eastern Cooperative Oncology Group Performance Status of 2-3, and experiencing fatigue according to the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core-15-palliative criteria. Participants received twice-daily oral administration of 2 mg betamethasone (4 mg/day) or placebo for 7 days, with fatigue assessed using EORTC QLQ-C15-PAL subscale and numerical rating scale (NRS) score (at baseline and day 7). The trial was registered under the University Hospital Medical Information Network (UMIN)000011913. Among the 267 screened patients, 81 were eligible, of which 70 were evaluable (betamethasone, 33; placebo, 37). The mean difference in the EORTC-QLQ-C15-PAL fatigue subscale was -8.2 (95% CIs: -22.3, 0.0; P=0.178) and in a NRS for fatigue was -1.2 (95% CIs: -2.5, -0.01; P=0.048), respectively. Emotional function, appetite loss, and global-health were slightly better in the betamethasone group than in the placebo group. The impact of betamethasone 4 mg/day on alleviating fatigue in patients with advanced cancer in the last weeks of life did not reach statistical significance in the EORTC-QLQ-C15-PAL as the primary endpoint, however, it was significant in the NRS, the secondary endpoint.

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Copyright © 2024. Published by Elsevier Inc.

Déclaration de conflit d'intérêts

Declaration of competinh interest Kikuko Miyazaki reports personal fees from Bayer Yakuhin Ltd..and Intage Healthcare Inc. Yoshimi Suzukamo reports personal fees from Bayer Yakuhin Ltd., Mebix Inc., ASKA Pharmaceutical Co. Ltd. and Qualitest Inc. Tosiya Sato reports as Grants from AMED (JP21lk0201702). Takeo Nakayama reports COI as follows: Research grants from I&H Co., Ltd., Cocokarafine Co., Ltd., and Konica Minolta Inc: consulting fees from Otsuka Pharmaceutical Co and Takeda Pharmaceutical Co;Honoraria from Pfizer Japan Inc., MSD K.K., Chugai Pharamaceutical Co., Takeda Pharmaceutical Co., Janssen Pharmaceutical K.K., Boehringer Ingelheim International GmbH, Eli Lilly Japan K.K., Maruho Co., Ltd., Mitsubishi Tanabe Pharma Co, Novartis Pharma K.K., Allergan Japan K.K., Maruho Co., Ltd., Novo Nordisk Pharma Ltd.,TOA EIYO Ltd., Dentsu co., ONO PHARMACEUTICAL CO., LTD., GSK plc, Alexion Pharmaceuticals Inc., Cannon Medical Systems Co, Kowa Company Ltd, Araya. Stock options from Bon Bon Inc.; Donations from CancerScan and YUYAMA Co.