Effects of ghrelin administration during chemotherapy with advanced esophageal cancer patients: A prospective, randomized, placebo-controlled phase 2 study

Yuichiro Hiura, Shuji Takiguchi, Kazuyoshi Yamamoto, Tsuyoshi Takahashi, Yukinori Kurokawa, Makoto Yamasaki, Kiyokazu Nakajima, Hiroshi Miyata, Yoshiyuki Fujiwara, Masaki Mori, Kenji Kangawa, Yuichiro Doki

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Abstract

BACKGROUND: Cisplatin reduces plasma ghrelin levels through the 5-hydroxytryptamine (5-HT) receptor. This may cause cisplatin-induced gastrointestinal disorders and hinders the continuation of chemotherapy. The authors of this report conducted a prospective, randomized phase 2 trial to evaluate the effects of exogenous ghrelin during cisplatin-based chemotherapy. METHODS: Forty-Two patients with esophageal cancer who were receiving cisplatin-based neoadjuvant chemotherapy were assigned to either a ghrelin group (n = 21) or a placebo group (n = 21). They received either intravenous infusions of synthetic human ghrelin (3 μg/kg) or saline twice daily for 1 week with cisplatin administration. The primary endpoint was changes in oral calorie intake, and the secondary endpoints were chemotherapy-related adverse events; appetite visual analog scale (VAS) scores; changes in gastrointestinal hormones and nutritional status, including rapid turnover proteins, and quality of life (QoL) estimated with the European Organization for Research and Treatment of Cancer QoL core questionnaire (QLQ-C30). RESULTS: Two patients were excluded from the final analysis: One patient suspended ghrelin administration because of excessive diaphoresis, and another patient in the placebo group failed to monitor the self-questionnaire. Food intake and appetite VAS scores were significantly higher in the ghrelin group than in the placebo group (18.2 ± 5.2 kcal/kg/day vs 12.7 ± 3.4 kcal/kg/day [P =.001] and 6.2 ± 0.9 vs 4.1 ± 0.9 [P <.0001], respectively). Patients in the ghrelin group had fewer adverse events during chemotherapy related to anorexia and nausea than patients in the control group. Significant deterioration was noted after chemotherapy in the placebo group in QoL scores, appetite, nausea and vomiting, and global health status. CONCLUSIONS: Short-Term administration of exogenous ghrelin at the start of cisplatin-based chemotherapy stimulated food intake and minimized adverse events.

Original languageEnglish
Pages (from-to)4785-4794
Number of pages10
JournalCancer
Volume118
Issue number19
DOIs
Publication statusPublished - Oct 1 2012
Externally publishedYes

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Ghrelin
Esophageal Neoplasms
Placebos
Cisplatin
Drug Therapy
Appetite
Quality of Life
Visual Analog Scale
Nausea
Eating
Gastrointestinal Hormones
Serotonin Receptors
Anorexia
Nutritional Status
Intravenous Infusions
Health Status
Vomiting
Organizations
Control Groups
Research

All Science Journal Classification (ASJC) codes

  • Oncology
  • Cancer Research

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Effects of ghrelin administration during chemotherapy with advanced esophageal cancer patients : A prospective, randomized, placebo-controlled phase 2 study. / Hiura, Yuichiro; Takiguchi, Shuji; Yamamoto, Kazuyoshi; Takahashi, Tsuyoshi; Kurokawa, Yukinori; Yamasaki, Makoto; Nakajima, Kiyokazu; Miyata, Hiroshi; Fujiwara, Yoshiyuki; Mori, Masaki; Kangawa, Kenji; Doki, Yuichiro.

In: Cancer, Vol. 118, No. 19, 01.10.2012, p. 4785-4794.

Research output: Contribution to journalArticle

Hiura, Y, Takiguchi, S, Yamamoto, K, Takahashi, T, Kurokawa, Y, Yamasaki, M, Nakajima, K, Miyata, H, Fujiwara, Y, Mori, M, Kangawa, K & Doki, Y 2012, 'Effects of ghrelin administration during chemotherapy with advanced esophageal cancer patients: A prospective, randomized, placebo-controlled phase 2 study', Cancer, vol. 118, no. 19, pp. 4785-4794. https://doi.org/10.1002/cncr.27430
Hiura, Yuichiro ; Takiguchi, Shuji ; Yamamoto, Kazuyoshi ; Takahashi, Tsuyoshi ; Kurokawa, Yukinori ; Yamasaki, Makoto ; Nakajima, Kiyokazu ; Miyata, Hiroshi ; Fujiwara, Yoshiyuki ; Mori, Masaki ; Kangawa, Kenji ; Doki, Yuichiro. / Effects of ghrelin administration during chemotherapy with advanced esophageal cancer patients : A prospective, randomized, placebo-controlled phase 2 study. In: Cancer. 2012 ; Vol. 118, No. 19. pp. 4785-4794.
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abstract = "BACKGROUND: Cisplatin reduces plasma ghrelin levels through the 5-hydroxytryptamine (5-HT) receptor. This may cause cisplatin-induced gastrointestinal disorders and hinders the continuation of chemotherapy. The authors of this report conducted a prospective, randomized phase 2 trial to evaluate the effects of exogenous ghrelin during cisplatin-based chemotherapy. METHODS: Forty-Two patients with esophageal cancer who were receiving cisplatin-based neoadjuvant chemotherapy were assigned to either a ghrelin group (n = 21) or a placebo group (n = 21). They received either intravenous infusions of synthetic human ghrelin (3 μg/kg) or saline twice daily for 1 week with cisplatin administration. The primary endpoint was changes in oral calorie intake, and the secondary endpoints were chemotherapy-related adverse events; appetite visual analog scale (VAS) scores; changes in gastrointestinal hormones and nutritional status, including rapid turnover proteins, and quality of life (QoL) estimated with the European Organization for Research and Treatment of Cancer QoL core questionnaire (QLQ-C30). RESULTS: Two patients were excluded from the final analysis: One patient suspended ghrelin administration because of excessive diaphoresis, and another patient in the placebo group failed to monitor the self-questionnaire. Food intake and appetite VAS scores were significantly higher in the ghrelin group than in the placebo group (18.2 ± 5.2 kcal/kg/day vs 12.7 ± 3.4 kcal/kg/day [P =.001] and 6.2 ± 0.9 vs 4.1 ± 0.9 [P <.0001], respectively). Patients in the ghrelin group had fewer adverse events during chemotherapy related to anorexia and nausea than patients in the control group. Significant deterioration was noted after chemotherapy in the placebo group in QoL scores, appetite, nausea and vomiting, and global health status. CONCLUSIONS: Short-Term administration of exogenous ghrelin at the start of cisplatin-based chemotherapy stimulated food intake and minimized adverse events.",
author = "Yuichiro Hiura and Shuji Takiguchi and Kazuyoshi Yamamoto and Tsuyoshi Takahashi and Yukinori Kurokawa and Makoto Yamasaki and Kiyokazu Nakajima and Hiroshi Miyata and Yoshiyuki Fujiwara and Masaki Mori and Kenji Kangawa and Yuichiro Doki",
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AU - Yamamoto, Kazuyoshi

AU - Takahashi, Tsuyoshi

AU - Kurokawa, Yukinori

AU - Yamasaki, Makoto

AU - Nakajima, Kiyokazu

AU - Miyata, Hiroshi

AU - Fujiwara, Yoshiyuki

AU - Mori, Masaki

AU - Kangawa, Kenji

AU - Doki, Yuichiro

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N2 - BACKGROUND: Cisplatin reduces plasma ghrelin levels through the 5-hydroxytryptamine (5-HT) receptor. This may cause cisplatin-induced gastrointestinal disorders and hinders the continuation of chemotherapy. The authors of this report conducted a prospective, randomized phase 2 trial to evaluate the effects of exogenous ghrelin during cisplatin-based chemotherapy. METHODS: Forty-Two patients with esophageal cancer who were receiving cisplatin-based neoadjuvant chemotherapy were assigned to either a ghrelin group (n = 21) or a placebo group (n = 21). They received either intravenous infusions of synthetic human ghrelin (3 μg/kg) or saline twice daily for 1 week with cisplatin administration. The primary endpoint was changes in oral calorie intake, and the secondary endpoints were chemotherapy-related adverse events; appetite visual analog scale (VAS) scores; changes in gastrointestinal hormones and nutritional status, including rapid turnover proteins, and quality of life (QoL) estimated with the European Organization for Research and Treatment of Cancer QoL core questionnaire (QLQ-C30). RESULTS: Two patients were excluded from the final analysis: One patient suspended ghrelin administration because of excessive diaphoresis, and another patient in the placebo group failed to monitor the self-questionnaire. Food intake and appetite VAS scores were significantly higher in the ghrelin group than in the placebo group (18.2 ± 5.2 kcal/kg/day vs 12.7 ± 3.4 kcal/kg/day [P =.001] and 6.2 ± 0.9 vs 4.1 ± 0.9 [P <.0001], respectively). Patients in the ghrelin group had fewer adverse events during chemotherapy related to anorexia and nausea than patients in the control group. Significant deterioration was noted after chemotherapy in the placebo group in QoL scores, appetite, nausea and vomiting, and global health status. CONCLUSIONS: Short-Term administration of exogenous ghrelin at the start of cisplatin-based chemotherapy stimulated food intake and minimized adverse events.

AB - BACKGROUND: Cisplatin reduces plasma ghrelin levels through the 5-hydroxytryptamine (5-HT) receptor. This may cause cisplatin-induced gastrointestinal disorders and hinders the continuation of chemotherapy. The authors of this report conducted a prospective, randomized phase 2 trial to evaluate the effects of exogenous ghrelin during cisplatin-based chemotherapy. METHODS: Forty-Two patients with esophageal cancer who were receiving cisplatin-based neoadjuvant chemotherapy were assigned to either a ghrelin group (n = 21) or a placebo group (n = 21). They received either intravenous infusions of synthetic human ghrelin (3 μg/kg) or saline twice daily for 1 week with cisplatin administration. The primary endpoint was changes in oral calorie intake, and the secondary endpoints were chemotherapy-related adverse events; appetite visual analog scale (VAS) scores; changes in gastrointestinal hormones and nutritional status, including rapid turnover proteins, and quality of life (QoL) estimated with the European Organization for Research and Treatment of Cancer QoL core questionnaire (QLQ-C30). RESULTS: Two patients were excluded from the final analysis: One patient suspended ghrelin administration because of excessive diaphoresis, and another patient in the placebo group failed to monitor the self-questionnaire. Food intake and appetite VAS scores were significantly higher in the ghrelin group than in the placebo group (18.2 ± 5.2 kcal/kg/day vs 12.7 ± 3.4 kcal/kg/day [P =.001] and 6.2 ± 0.9 vs 4.1 ± 0.9 [P <.0001], respectively). Patients in the ghrelin group had fewer adverse events during chemotherapy related to anorexia and nausea than patients in the control group. Significant deterioration was noted after chemotherapy in the placebo group in QoL scores, appetite, nausea and vomiting, and global health status. CONCLUSIONS: Short-Term administration of exogenous ghrelin at the start of cisplatin-based chemotherapy stimulated food intake and minimized adverse events.

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