A double-blind, crossover, randomized dose-comparison trial of granisetron for the prevention of acute and delayed nausea and emesis in children receiving moderately emetogenic carboplatin-based chemotherapy

Su G. Berrak, Nihal Ozdemir, Nadi Bakirci, Emine Turkkan, Cengiz Canpolat, Bahar Beker, Asim Yoruk

Research output: Contribution to journalArticle

12 Citations (Scopus)

Abstract

Background: Granisetron is a safe and effective prophylaxis for nausea and vomiting associated with moderate to highly emetogenic chemotherapy. Few trials have been conducted to determine the optimal effective dose of granisetron in children with cancer. The objective of this report was to compare two doses of granisetron in patients with optic pathway tumors receiving moderately emetogenic doses of carboplatin. Patients and methods: In this double-blind, crossover, randomized study, antiemetic efficacy and tolerability of two dose levels (10 and 40 μg/kg) of granisetron in the prevention of acute and delayed nausea/emesis were compared in children and young adults. A total of 18 patients (13 boys) aged 1-23 years (median 7.7 years) treated with a moderately emetogenic dose of carboplatin were randomly assigned to receive either 10 or 40 μg/kg of slow granisetron intravenous (i.v.) infusions at alternating cycles of chemotherapy in a blinded fashion until the end of the study period or until their chemotherapy regimen ended. In this way, the patients acted as their own controls. Results: Patients in the granisetron 10 and 40 μg/kg groups received 104 and 121 cycles of chemotherapy, respectively. There was no significant difference in antiemetic efficacy in terms of nausea and emesis between the dose groups in the first 5 days of chemotherapy. The treatment was well tolerated. Conclusion: We conclude that granisetron 10 and 40 μg/kg have comparable efficacy in controlling carboplatin-induced acute and delayed nausea/emesis and is well tolerated in children and young adults.

Original languageEnglish (US)
Pages (from-to)1163-1168
Number of pages6
JournalSupportive Care in Cancer
Volume15
Issue number10
DOIs
StatePublished - Oct 2007
Externally publishedYes

Fingerprint

Granisetron
Carboplatin
Nausea
Vomiting
Drug Therapy
Antiemetics
Young Adult
Double-Blind Method
Intravenous Infusions
Cross-Over Studies
Neoplasms

Keywords

  • Antiemetic
  • Chemotherapy
  • Dose comparison
  • Efficacy
  • Granisetron

ASJC Scopus subject areas

  • Oncology
  • Nursing(all)

Cite this

A double-blind, crossover, randomized dose-comparison trial of granisetron for the prevention of acute and delayed nausea and emesis in children receiving moderately emetogenic carboplatin-based chemotherapy. / Berrak, Su G.; Ozdemir, Nihal; Bakirci, Nadi; Turkkan, Emine; Canpolat, Cengiz; Beker, Bahar; Yoruk, Asim.

In: Supportive Care in Cancer, Vol. 15, No. 10, 10.2007, p. 1163-1168.

Research output: Contribution to journalArticle

Berrak, Su G. ; Ozdemir, Nihal ; Bakirci, Nadi ; Turkkan, Emine ; Canpolat, Cengiz ; Beker, Bahar ; Yoruk, Asim. / A double-blind, crossover, randomized dose-comparison trial of granisetron for the prevention of acute and delayed nausea and emesis in children receiving moderately emetogenic carboplatin-based chemotherapy. In: Supportive Care in Cancer. 2007 ; Vol. 15, No. 10. pp. 1163-1168.
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T1 - A double-blind, crossover, randomized dose-comparison trial of granisetron for the prevention of acute and delayed nausea and emesis in children receiving moderately emetogenic carboplatin-based chemotherapy

AU - Berrak, Su G.

AU - Ozdemir, Nihal

AU - Bakirci, Nadi

AU - Turkkan, Emine

AU - Canpolat, Cengiz

AU - Beker, Bahar

AU - Yoruk, Asim

PY - 2007/10

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N2 - Background: Granisetron is a safe and effective prophylaxis for nausea and vomiting associated with moderate to highly emetogenic chemotherapy. Few trials have been conducted to determine the optimal effective dose of granisetron in children with cancer. The objective of this report was to compare two doses of granisetron in patients with optic pathway tumors receiving moderately emetogenic doses of carboplatin. Patients and methods: In this double-blind, crossover, randomized study, antiemetic efficacy and tolerability of two dose levels (10 and 40 μg/kg) of granisetron in the prevention of acute and delayed nausea/emesis were compared in children and young adults. A total of 18 patients (13 boys) aged 1-23 years (median 7.7 years) treated with a moderately emetogenic dose of carboplatin were randomly assigned to receive either 10 or 40 μg/kg of slow granisetron intravenous (i.v.) infusions at alternating cycles of chemotherapy in a blinded fashion until the end of the study period or until their chemotherapy regimen ended. In this way, the patients acted as their own controls. Results: Patients in the granisetron 10 and 40 μg/kg groups received 104 and 121 cycles of chemotherapy, respectively. There was no significant difference in antiemetic efficacy in terms of nausea and emesis between the dose groups in the first 5 days of chemotherapy. The treatment was well tolerated. Conclusion: We conclude that granisetron 10 and 40 μg/kg have comparable efficacy in controlling carboplatin-induced acute and delayed nausea/emesis and is well tolerated in children and young adults.

AB - Background: Granisetron is a safe and effective prophylaxis for nausea and vomiting associated with moderate to highly emetogenic chemotherapy. Few trials have been conducted to determine the optimal effective dose of granisetron in children with cancer. The objective of this report was to compare two doses of granisetron in patients with optic pathway tumors receiving moderately emetogenic doses of carboplatin. Patients and methods: In this double-blind, crossover, randomized study, antiemetic efficacy and tolerability of two dose levels (10 and 40 μg/kg) of granisetron in the prevention of acute and delayed nausea/emesis were compared in children and young adults. A total of 18 patients (13 boys) aged 1-23 years (median 7.7 years) treated with a moderately emetogenic dose of carboplatin were randomly assigned to receive either 10 or 40 μg/kg of slow granisetron intravenous (i.v.) infusions at alternating cycles of chemotherapy in a blinded fashion until the end of the study period or until their chemotherapy regimen ended. In this way, the patients acted as their own controls. Results: Patients in the granisetron 10 and 40 μg/kg groups received 104 and 121 cycles of chemotherapy, respectively. There was no significant difference in antiemetic efficacy in terms of nausea and emesis between the dose groups in the first 5 days of chemotherapy. The treatment was well tolerated. Conclusion: We conclude that granisetron 10 and 40 μg/kg have comparable efficacy in controlling carboplatin-induced acute and delayed nausea/emesis and is well tolerated in children and young adults.

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KW - Chemotherapy

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KW - Efficacy

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