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Supportive Care in Cancer

, Volume 24, Issue 2, pp 637–646 | Cite as

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)

  • Satoru Iwase
  • Takashi Kawaguchi
  • Daisuke Yotsumoto
  • Takako Doi
  • Kyuichiro Miyara
  • Hiroki Odagiri
  • Kaoru Kitamura
  • Keisuke Ariyoshi
  • Tempei Miyaji
  • Hiroto Ishiki
  • Kenichi Inoue
  • Chizuko Tsutsumi
  • Yoshiaki Sagara
  • Takuhiro Yamaguchi
Original Article

Abstract

Purpose

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.

Conclusion

IP may control moderate-severe CRF in breast cancer patients.

Trial registration

The registration number of this study in the University Hospital Medical Information Network Clinical Trials Registry (UMIN-CTR) is UMIN000008646.

Keywords

Cancer-related fatigue Chemotherapy-induced fatigue Supplement Quality of life Complementary and alternative medicine 

Notes

Conflict of interest

This was a joint study conducted by The University of Tokyo and Otsuka Pharmaceutical Factory Incorporated. Financial resources and Inner Power® were provided by Otsuka Pharmaceutical Factory Incorporated. The funding source had no influence on the study outcomes, and the authors were free to interpret the data according to a strict scientific rationale. The authors have no other conflicts of interest to disclose. The authors have full control of all primary data and agree to allow the journal to review their data if requested.

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Copyright information

© Springer-Verlag Berlin Heidelberg 2015

Authors and Affiliations

  • Satoru Iwase
    • 1
  • Takashi Kawaguchi
    • 2
  • Daisuke Yotsumoto
    • 3
  • Takako Doi
    • 4
  • Kyuichiro Miyara
    • 5
  • Hiroki Odagiri
    • 6
  • Kaoru Kitamura
    • 7
  • Keisuke Ariyoshi
    • 1
    • 8
  • Tempei Miyaji
    • 8
    • 9
  • Hiroto Ishiki
    • 1
    • 8
  • Kenichi Inoue
    • 4
  • Chizuko Tsutsumi
    • 4
  • Yoshiaki Sagara
    • 3
  • Takuhiro Yamaguchi
    • 8
    • 9
    • 10
  1. 1.Department of Palliative Medicine, The Institute of Medical ScienceThe University of TokyoMinato-kuJapan
  2. 2.Department of Practical PharmacyTokyo University of Pharmacy and Life SciencesHachiojiJapan
  3. 3.Department of Breast SurgerySagara HospitalKagoshima CityJapan
  4. 4.Kamakura Breast Cancer CenterShonan Memorial HospitalKamakura-shiJapan
  5. 5.Miyara Clinic, 2-3-1 IsoUrasoeJapan
  6. 6.Department of Breast SurgeryHirosaki National HospitalHirosakiJapan
  7. 7.Nagumo Clinic FukuokaChuo-kuJapan
  8. 8.Japanese Organization for Research and Treatment of Cancer (JORTC)Taito-kuJapan
  9. 9.Department of Clinical Trial Data Management, Graduate School of MedicineThe University of TokyoBunkyo-kuJapan
  10. 10.Division of BiostatisticsTohoku University Graduate School of MedicineSendaiJapan

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