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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)

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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.

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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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Authors and Affiliations

  1. Department of Palliative Medicine, The Institute of Medical Science, The University of Tokyo, 4-6-1 Shirokanedai, Minato-ku, Tokyo, 108-8639, Japan

    Satoru Iwase, Keisuke Ariyoshi & Hiroto Ishiki

  2. Department of Practical Pharmacy, Tokyo University of Pharmacy and Life Sciences, 1432-1 Horinouchi, Hachioji, Tokyo, 192-0392, Japan

    Takashi Kawaguchi

  3. Department of Breast Surgery, Sagara Hospital, 3-31 Matsubara-cho, Kagoshima City, Kagoshima, 892-0833, Japan

    Daisuke Yotsumoto & Yoshiaki Sagara

  4. Kamakura Breast Cancer Center, Shonan Memorial Hospital, 2-2-60 Fueda, Kamakura-shi, Kanagawa, 248-0027, Japan

    Takako Doi, Kenichi Inoue & Chizuko Tsutsumi

  5. Miyara Clinic, 2-3-1 Iso, Urasoe, Okinawa, 901-2132, Japan

    Kyuichiro Miyara

  6. Department of Breast Surgery, Hirosaki National Hospital, 1 Tomino-cho, Hirosaki, Aomori, 036-8545, Japan

    Hiroki Odagiri

  7. Nagumo Clinic Fukuoka, 2-8-1, Daimyo, Chuo-ku, Fukuoka, 810-0041, Japan

    Kaoru Kitamura

  8. Japanese Organization for Research and Treatment of Cancer (JORTC), 1-5-9-206, Yanaka, Taito-ku, Tokyo, 110-0001, Japan

    Keisuke Ariyoshi, Tempei Miyaji, Hiroto Ishiki & Takuhiro Yamaguchi

  9. Department of Clinical Trial Data Management, Graduate School of Medicine, The University of Tokyo, 7-3-1 Hongo, Bunkyo-ku, Tokyo, 113-8655, Japan

    Tempei Miyaji & Takuhiro Yamaguchi

  10. Division of Biostatistics, Tohoku University Graduate School of Medicine, 2-1 Seiryo-machi, Aoba-ku, Sendai, Miyagi, 980-8575, Japan

    Takuhiro Yamaguchi

Authors
  1. Satoru Iwase
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  2. Takashi Kawaguchi
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  3. Daisuke Yotsumoto
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  4. Takako Doi
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  5. Kyuichiro Miyara
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  6. Hiroki Odagiri
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  7. Kaoru Kitamura
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  8. Keisuke Ariyoshi
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  9. Tempei Miyaji
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  10. Hiroto Ishiki
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  11. Kenichi Inoue
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  12. Chizuko Tsutsumi
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  13. Yoshiaki Sagara
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  14. Takuhiro Yamaguchi
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Correspondence to Keisuke Ariyoshi.

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Iwase, S., Kawaguchi, T., Yotsumoto, D. et al. 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). Support Care Cancer 24, 637–646 (2016). https://doi.org/10.1007/s00520-015-2824-4

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  • DOI: https://doi.org/10.1007/s00520-015-2824-4

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