title: Efficacy of corticosteroids for cancer-related fatigue: A pilot randomized placebo-controlled trial of advanced cancer patients.
abstract: OBJECTIVE
  Cancer-related fatigue (CRF) is a common and one of the most important issues in palliative medicine, and it has been demonstrated to have a significant impact on patient quality of life (QoL). The present pilot randomized controlled study evaluated the efficacy and toxicity of methylprednisolone (MP) for CRF in advanced cancer patients.
  
  
  METHODS
  Our study was planned as a randomized, double-blind, multicenter, placebo-controlled trial. Patients were randomly assigned to an MP group, who received 32 mg/day of MP orally for 7 days, and a placebo group. The primary endpoint was an improvement in visual analog scale (VAS) score for fatigue from baseline to day 7. The secondary endpoints were improvements in appetite loss and QoL as well as evaluating the safety of corticosteroids as palliative therapy.
  
  
  RESULTS
  It was not possible to complete patient registration. In total, 35 patients were randomly assigned to an MP group (n = 18) and a placebo group (n = 17). The mean changes in VAS score for fatigue were -9.06 in the placebo group and -1.56 in the MP group, and for appetite loss -6.44 in the placebo group and -8.06 in the MP group. In addition, there was no evidence that methylprednisolone improved appetite loss or QoL compared to placebo. The incidence of adverse effects was not greater in the MP group. Significant of Result: We conclude that our sample size was too small to prove the efficacy of methylprednisolone in improving fatigue. Our results were reported as a pilot study performed to support a subsequent larger trial.
authors.affiliation: Department of Oncology,Teikyo University,Tokyo,Japan.
authors.forename: Kenji
authors.initials: K
authors.lastname: Eguchi
authors.affiliation: Department of Gastroenterological Surgery,Cancer Institute, Ariake Hospital,Japanese Foundation for Cancer Research,Koto-ku,Tokyo,Japan.
authors.forename: Michitaka
authors.initials: M
authors.lastname: Honda
authors.affiliation: Ginza Namikidori Clinic,Tokyo,Japan.
authors.forename: Tatusji
authors.initials: T
authors.lastname: Kataoka
authors.affiliation: Department of Cancer Palliative Therapy,Cancer Institute, Ariake Hospital, Japanese Foundation for Cancer Research,Koto-ku,Tokyo,Japan.
authors.forename: Taketo
authors.initials: T
authors.lastname: Mukouyama
authors.affiliation: Department of Palliative Medicine,Osaka University,Osaka,Japan.
authors.forename: Satoru
authors.initials: S
authors.lastname: Tsuneto
authors.affiliation: Tokai Central Hospital,Kakamigahara,Japan.
authors.forename: Junichi
authors.initials: J
authors.lastname: Sakamoto
authors.affiliation: Translational Research and Clinical Trial Center,Hokkaido University,Sapporo,Hokkaido,Japan.
authors.forename: Koji
authors.initials: K
authors.lastname: Oba
authors.affiliation: Japanese Foundation for Multidisciplinary Treatment of Cancer,Tokyo,Japan.
authors.forename: Shigetoyo
authors.initials: S
authors.lastname: Saji
mesh_terms: D000368:Aged; D000369:Aged, 80 and over; D004311:Double-Blind Method; D005221:Fatigue / Q000188:drug therapy* / Q000209:etiology; D001068:Feeding and Eating Disorders / Q000188:drug therapy* / Q000209:etiology; D005260:Female; D005938:Glucocorticoids / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use; D006801:Humans; D008297:Male; D008775:Methylprednisolone / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D008875:Middle Aged; D009369:Neoplasms / Q000150:complications / Q000188:drug therapy*; D010166:Palliative Care / Q000379:methods*; D010865:Pilot Projects; D011788:Quality of Life; D016896:Treatment Outcome
chemical_list: D005938:Glucocorticoids; D008775:Methylprednisolone
keywords: Cancer-related fatigue; Corticosteroids; Methylprednisolone; Palliative care