title: Efficacy and safety of an amino acid jelly containing coenzyme Q10 and L-carnitine in controlling fatigue in breast cancer patients receiving chemotherapy: a multi-institutional, randomized, exploratory trial (JORTC-CAM01).
abstract: OBJECTIVE
  Cancer-related fatigue (CRF) is one of the most common symptoms reported by cancer patients. This randomized trial investigated the efficacy of the amino acid jelly Inner Power(®) (IP), a semi-solid, orally administrable dietary supplement containing coenzyme Q10 and L-carnitine, in controlling CRF in breast cancer patients in Japan.
  
  
  METHODS
  Breast cancer patients with CRF undergoing chemotherapy were randomly assigned to receive IP once daily or regular care for 21 days. The primary endpoint was the change in the worst level of fatigue during the past 24 h (Brief Fatigue Inventory [BFI] item 3 score) from day 1 (baseline) to day 22. Secondary endpoints were change in global fatigue score (GFS; the average of all BFI items), anxiety and depression assessed by the Hospital Anxiety and Depression Scale (HADS), quality of life assessed by the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30) and EORTC Breast Cancer-Specific QLQ (EORTC QLQ-BR23), and adverse events.
  
  
  RESULTS
  Fifty-nine patients were enrolled in the study, of whom 57 were included in the efficacy analysis. Median patient age was 50 years. Changes in the worst level of fatigue, GFS, and current feeling of fatigue were significantly different between the intervention and control groups, whereas the change in the average feeling of fatigue was not significantly different between groups. HADS, EORTC QLQ-C30, and EORTC QLQ-BR23 scores were not significantly different between the two groups. No severe adverse events were observed.
  
  
  CONCLUSIONS
  IP may control moderate-severe CRF in breast cancer patients.
  
  
  BACKGROUND
  The registration number of this study in the University Hospital Medical Information Network Clinical Trials Registry (UMIN-CTR) is UMIN000008646.
authors.affiliation: Department of Palliative Medicine, The Institute of Medical Science, The University of Tokyo, 4-6-1 Shirokanedai, Minato-ku, Tokyo, 108-8639, Japan.
authors.forename: Satoru
authors.initials: S
authors.lastname: Iwase
authors.affiliation: Department of Practical Pharmacy, Tokyo University of Pharmacy and Life Sciences, 1432-1 Horinouchi, Hachioji, Tokyo, 192-0392, Japan.
authors.forename: Takashi
authors.initials: T
authors.lastname: Kawaguchi
authors.affiliation: Department of Breast Surgery, Sagara Hospital, 3-31 Matsubara-cho, Kagoshima City, Kagoshima, 892-0833, Japan.
authors.forename: Daisuke
authors.initials: D
authors.lastname: Yotsumoto
authors.affiliation: Kamakura Breast Cancer Center, Shonan Memorial Hospital, 2-2-60 Fueda, Kamakura-shi, Kanagawa, 248-0027, Japan.
authors.forename: Takako
authors.initials: T
authors.lastname: Doi
authors.affiliation: Miyara Clinic, 2-3-1 Iso, Urasoe, Okinawa, 901-2132, Japan.
authors.forename: Kyuichiro
authors.initials: K
authors.lastname: Miyara
authors.affiliation: Department of Breast Surgery, Hirosaki National Hospital, 1 Tomino-cho, Hirosaki, Aomori, 036-8545, Japan.
authors.forename: Hiroki
authors.initials: H
authors.lastname: Odagiri
authors.affiliation: Nagumo Clinic Fukuoka, 2-8-1, Daimyo, Chuo-ku, Fukuoka, 810-0041, Japan.
authors.forename: Kaoru
authors.initials: K
authors.lastname: Kitamura
authors.affiliation: Department of Palliative Medicine, The Institute of Medical Science, The University of Tokyo, 4-6-1 Shirokanedai, Minato-ku, Tokyo, 108-8639, Japan. k-ariyoshi@umin.ac.jp.|Japanese Organization for Research and Treatment of Cancer (JORTC), 1-5-9-206, Yanaka, Taito-ku, Tokyo, 110-0001, Japan. k-ariyoshi@umin.ac.jp.
authors.forename: Keisuke
authors.initials: K
authors.lastname: Ariyoshi
authors.affiliation: Japanese Organization for Research and Treatment of Cancer (JORTC), 1-5-9-206, Yanaka, Taito-ku, Tokyo, 110-0001, Japan.|Department of Clinical Trial Data Management, Graduate School of Medicine, The University of Tokyo, 7-3-1 Hongo, Bunkyo-ku, Tokyo, 113-8655, Japan.
authors.forename: Tempei
authors.initials: T
authors.lastname: Miyaji
authors.affiliation: Department of Palliative Medicine, The Institute of Medical Science, The University of Tokyo, 4-6-1 Shirokanedai, Minato-ku, Tokyo, 108-8639, Japan.|Japanese Organization for Research and Treatment of Cancer (JORTC), 1-5-9-206, Yanaka, Taito-ku, Tokyo, 110-0001, Japan.
authors.forename: Hiroto
authors.initials: H
authors.lastname: Ishiki
authors.affiliation: Kamakura Breast Cancer Center, Shonan Memorial Hospital, 2-2-60 Fueda, Kamakura-shi, Kanagawa, 248-0027, Japan.
authors.forename: Kenichi
authors.initials: K
authors.lastname: Inoue
authors.affiliation: Kamakura Breast Cancer Center, Shonan Memorial Hospital, 2-2-60 Fueda, Kamakura-shi, Kanagawa, 248-0027, Japan.
authors.forename: Chizuko
authors.initials: C
authors.lastname: Tsutsumi
authors.affiliation: Department of Breast Surgery, Sagara Hospital, 3-31 Matsubara-cho, Kagoshima City, Kagoshima, 892-0833, Japan.
authors.forename: Yoshiaki
authors.initials: Y
authors.lastname: Sagara
authors.affiliation: Japanese Organization for Research and Treatment of Cancer (JORTC), 1-5-9-206, Yanaka, Taito-ku, Tokyo, 110-0001, Japan.|Department of Clinical Trial Data Management, Graduate School of Medicine, The University of Tokyo, 7-3-1 Hongo, Bunkyo-ku, Tokyo, 113-8655, Japan.|Division of Biostatistics, Tohoku University Graduate School of Medicine, 2-1 Seiryo-machi, Aoba-ku, Sendai, Miyagi, 980-8575, Japan.
authors.forename: Takuhiro
authors.initials: T
authors.lastname: Yamaguchi
mesh_terms: D000328:Adult; D000368:Aged; D001943:Breast Neoplasms / Q000188:drug therapy / Q000503:physiopathology*; D002331:Carnitine / Q000008:administration & dosage*; D005221:Fatigue / Q000188:drug therapy* / Q000209:etiology; D005260:Female; D006801:Humans; D008875:Middle Aged; D011788:Quality of Life; D014451:Ubiquinone / Q000008:administration & dosage / Q000031:analogs & derivatives*
chemical_list: D014451:Ubiquinone; C024989:coenzyme Q10; D002331:Carnitine
keywords: Cancer-related fatigue; Chemotherapy-induced fatigue; Complementary and alternative medicine; Quality of life; Supplement