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Randomized study of prevention of gastrointestinal toxicities by nutritional support using an amino acid-rich elemental diet during chemotherapy in patients with esophageal cancer (KDOG 1101)

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Abstract

Background

This randomized study was designed to evaluate the clinical effect of an elemental diet during chemotherapy in patients with esophageal cancer.

Methods

The inclusion criteria were as follows: (1) esophageal squamous cell carcinoma, (2) stage IB-IV, (3) schedule to receive docetaxel, cisplatin, and 5-fluorouracil (DCF chemotherapy), (4) 20–80 years old, (5) performance status of 0–2, (6) oral intake ability, and (7) written informed consent. Patients were divided into two groups: the elemental supplementary group and the non-supplementary group. Patients received ELENTAL® (160 g/day) orally 9 weeks after the start of chemotherapy. Primary endpoint was the incidence of grade 2 or higher gastrointestinal toxicity according to the Common Terminology Criteria for Adverse Events, version 4.0. Secondary endpoints were the incidence of all adverse events and the evaluation of nutritional status.

Results

Thirty-six patients in the elemental supplementary group and 35 patients in the non-supplementary group were included in the analysis. The incidence of grade 2 or higher gastrointestinal toxicity and all grade 3 or 4 adverse events did not differ significantly between the groups. In the elemental supplementary group, the body weight (p = 0.057), muscle mass (p = 0.056), and blood levels of transferrin (p = 0.009), total amino acids (p = 0.019), and essential amino acids (p = 0.006) tended to be maintained after chemotherapy.

Conclusion

Nutritional support provided by an amino acid-rich elemental diet was ineffective for reducing the incidence of adverse events caused by DCF chemotherapy in patients with esophageal cancer.

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Authors and Affiliations

  1. Department of Gastroenterology, Kitasato University School of Medicine, 1-15-1 Kitasato Minami, Sagamihara, 252-0374, Japan

    Chikatoshi Katada, Akinori Watanabe, Takuya Wada, Kenji Ishido, Yasuaki Furue & Wasaburo Koizumi

  2. Department of Nutrition, Kitasato University Hospital, 1-15-1 Kitasato Minami, Sagamihara, 252-0374, Japan

    Saeko Fukazawa & Teruko Sato

  3. Department of Pharmacy, Kitasato University Hospital, 1-15-1 Kitasato Minami, Sagamihara, 252-0374, Japan

    Mitsuhiro Sugawara

  4. Kitasato Clinical Research Center, Kitasato University School of Medicine, 1-15-1 Kitasato Minami, Sagamihara, 252-0374, Japan

    Yasutoshi Sakamoto

  5. Department of Nursing, Kitasato University Hospital, 1-15-1 Kitasato Minami, Sagamihara, 252-0374, Japan

    Kaoru Takahashi & Akiko Takahashi

  6. Department of Upper Gastrointestinal Surgery, Kitasato University School of Medicine, 1-15-1 Kitasato Minami, Sagamihara, 252-0374, Japan

    Hiroki Harada, Kei Hosoda, Keishi Yamashita & Naoki Hiki

  7. Division of Advanced Surgical Oncology, Research and Development Center for New Medical Frontiers, Kitasato University School of Medicine, 1-15-1 Kitasato Minami, Sagamihara, 252-0374, Japan

    Keishi Yamashita

  8. Department of Pathological Biochemistry, School of Allied Health Sciences, Kitasato University, 1-15-1 Kitasato Minami, Sagamihara, 252-0374, Japan

    Takafumi Ichikawa

  9. Department of Endocrinology, Diabetes and Metabolism, Kitasato University School of Medicine, 1-15-1 Kitasato Minami, Sagamihara, 252-0374, Japan

    Masayoshi Shichiri

  10. Department of Advanced Medicine Research and Development Center for New Medical Frontiers, Kitasato University School of Medicine, 1-15-1 Kitasato Minami, Sagamihara, 252-0374, Japan

    Satoshi Tanabe

Authors
  1. Chikatoshi Katada
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  2. Saeko Fukazawa
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  3. Mitsuhiro Sugawara
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  4. Yasutoshi Sakamoto
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  11. Hiroki Harada
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  16. Takafumi Ichikawa
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  19. Wasaburo Koizumi
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Contributions

Conception and design: CK, SF, MS, YS, KT, AT, TS, TI, MS, ST, WK. Collection and assembly of data: CK, SF, MS, YS, KT, AT, AW, TW, KI, YF, HH, KH, KY, NH. Data analysis and interpretation: CK, SF, MS, YS, KT, AT, HH, KH, KY, NH. Manuscript writing: CK, SF, MS, YS. Final approval of manuscript: all authors. Financial support: none. Administrative support: CK, SF, MS, YS, KT, AT. Provision of study materials or patients: all authors.

Corresponding author

Correspondence to Chikatoshi Katada.

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Ethical statement

All procedures followed were in accordance with the ethical standards of the responsible committee on human experimentation (institutional and national) and with the Helsinki Declaration of 1964 and later versions. Informed consent or a substitute was obtained from all patients included in the study.

Conflict of interest

There is no financial support for the present study. The authors declare that they have no competing interests.

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Katada, C., Fukazawa, S., Sugawara, M. et al. Randomized study of prevention of gastrointestinal toxicities by nutritional support using an amino acid-rich elemental diet during chemotherapy in patients with esophageal cancer (KDOG 1101). Esophagus 18, 296–305 (2021). https://doi.org/10.1007/s10388-020-00787-w

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