Efficacy of Prophylactic Treatment for Oxycodone-Induced Nausea and Vomiting Among Patients with Cancer Pain (POINT)

A Randomized, Placebo-Controlled, Double-Blind Trial

Hiroaki Tsukuura, Masayuki Miyazaki, Tatsuya Morita, Mihoko Sugishita, Hiroshi Kato, Yuka Murasaki, Bishal Gyawali, Yoko Kubo, Masahiko Ando, Masashi Kondo, Kiyofumi Yamada, Yoshinori Hasegawa, Yuichi Ando

Research output: Contribution to journalArticle

1 Citation (Scopus)

Abstract

Background: Although opioid-induced nausea and vomiting (OINV) often result in analgesic undertreatment in patients with cancer, no randomized controlled trials have evaluated the efficacy of prophylactic antiemetics for preventing OINV. We conducted this randomized, placebo-controlled, double-blind trial to evaluate the efficacy and safety of prophylactic treatment with prochlorperazine for preventing OINV. Materials and Methods: Cancer patients who started to receive oral oxycodone were randomly assigned in a 1:1 ratio to receive either prochlorperazine 5 mg or placebo prophylactically, given three times daily for 5 days. The primary endpoint was the proportion of patients who had a complete response (CR) during the 120 hours of oxycodone treatment. CR was defined as no emetic episode and no use of rescue medication for nausea and vomiting during 5 days. Key secondary endpoints were the proportion of patients with emetic episodes, proportion of patients with moderate or severe nausea, quality of life, and proportion of treatment withdrawal. Results: From November 2013 through February 2016, a total of 120 patients were assigned to receive prochlorperazine (n = 60) or placebo (n = 60). There was no significant difference in CR rates (69.5% vs. 63.3%; p =.47) or any secondary endpoint between the groups. Patients who received prochlorperazine were more likely to experience severe somnolence (p =.048). Conclusion: Routine use of prochlorperazine as a prophylactic antiemetic at the initiation of treatment with opioids is not recommended. Further research is needed to evaluate whether other antiemetics would be effective in preventing OINV in specific patient populations. Implications for Practice: Prophylactic prochlorperazine seems to be ineffective in preventing opioid-induced nausea and vomiting (OINV) and may cause adverse events such as somnolence. Routine use of prophylactic prochlorperazine at the initiation of treatment with opioids is not recommended. Further research is needed to evaluate whether other antiemetics would be effective in preventing OINV in specific patient populations.

Original languageEnglish
Pages (from-to)367-374
Number of pages8
JournalOncologist
Volume23
Issue number3
DOIs
Publication statusPublished - 01-03-2018

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Oxycodone
Prochlorperazine
Nausea
Vomiting
Opioid Analgesics
Placebos
Antiemetics
Emetics
Therapeutics
Cancer Pain
Research
Population
Analgesics
Neoplasms
Randomized Controlled Trials
Quality of Life
Safety

All Science Journal Classification (ASJC) codes

  • Oncology
  • Cancer Research

Cite this

Tsukuura, Hiroaki ; Miyazaki, Masayuki ; Morita, Tatsuya ; Sugishita, Mihoko ; Kato, Hiroshi ; Murasaki, Yuka ; Gyawali, Bishal ; Kubo, Yoko ; Ando, Masahiko ; Kondo, Masashi ; Yamada, Kiyofumi ; Hasegawa, Yoshinori ; Ando, Yuichi. / Efficacy of Prophylactic Treatment for Oxycodone-Induced Nausea and Vomiting Among Patients with Cancer Pain (POINT) : A Randomized, Placebo-Controlled, Double-Blind Trial. In: Oncologist. 2018 ; Vol. 23, No. 3. pp. 367-374.
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title = "Efficacy of Prophylactic Treatment for Oxycodone-Induced Nausea and Vomiting Among Patients with Cancer Pain (POINT): A Randomized, Placebo-Controlled, Double-Blind Trial",
abstract = "Background: Although opioid-induced nausea and vomiting (OINV) often result in analgesic undertreatment in patients with cancer, no randomized controlled trials have evaluated the efficacy of prophylactic antiemetics for preventing OINV. We conducted this randomized, placebo-controlled, double-blind trial to evaluate the efficacy and safety of prophylactic treatment with prochlorperazine for preventing OINV. Materials and Methods: Cancer patients who started to receive oral oxycodone were randomly assigned in a 1:1 ratio to receive either prochlorperazine 5 mg or placebo prophylactically, given three times daily for 5 days. The primary endpoint was the proportion of patients who had a complete response (CR) during the 120 hours of oxycodone treatment. CR was defined as no emetic episode and no use of rescue medication for nausea and vomiting during 5 days. Key secondary endpoints were the proportion of patients with emetic episodes, proportion of patients with moderate or severe nausea, quality of life, and proportion of treatment withdrawal. Results: From November 2013 through February 2016, a total of 120 patients were assigned to receive prochlorperazine (n = 60) or placebo (n = 60). There was no significant difference in CR rates (69.5{\%} vs. 63.3{\%}; p =.47) or any secondary endpoint between the groups. Patients who received prochlorperazine were more likely to experience severe somnolence (p =.048). Conclusion: Routine use of prochlorperazine as a prophylactic antiemetic at the initiation of treatment with opioids is not recommended. Further research is needed to evaluate whether other antiemetics would be effective in preventing OINV in specific patient populations. Implications for Practice: Prophylactic prochlorperazine seems to be ineffective in preventing opioid-induced nausea and vomiting (OINV) and may cause adverse events such as somnolence. Routine use of prophylactic prochlorperazine at the initiation of treatment with opioids is not recommended. Further research is needed to evaluate whether other antiemetics would be effective in preventing OINV in specific patient populations.",
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Tsukuura, H, Miyazaki, M, Morita, T, Sugishita, M, Kato, H, Murasaki, Y, Gyawali, B, Kubo, Y, Ando, M, Kondo, M, Yamada, K, Hasegawa, Y & Ando, Y 2018, 'Efficacy of Prophylactic Treatment for Oxycodone-Induced Nausea and Vomiting Among Patients with Cancer Pain (POINT): A Randomized, Placebo-Controlled, Double-Blind Trial', Oncologist, vol. 23, no. 3, pp. 367-374. https://doi.org/10.1634/theoncologist.2017-0225

Efficacy of Prophylactic Treatment for Oxycodone-Induced Nausea and Vomiting Among Patients with Cancer Pain (POINT) : A Randomized, Placebo-Controlled, Double-Blind Trial. / Tsukuura, Hiroaki; Miyazaki, Masayuki; Morita, Tatsuya; Sugishita, Mihoko; Kato, Hiroshi; Murasaki, Yuka; Gyawali, Bishal; Kubo, Yoko; Ando, Masahiko; Kondo, Masashi; Yamada, Kiyofumi; Hasegawa, Yoshinori; Ando, Yuichi.

In: Oncologist, Vol. 23, No. 3, 01.03.2018, p. 367-374.

Research output: Contribution to journalArticle

TY - JOUR

T1 - Efficacy of Prophylactic Treatment for Oxycodone-Induced Nausea and Vomiting Among Patients with Cancer Pain (POINT)

T2 - A Randomized, Placebo-Controlled, Double-Blind Trial

AU - Tsukuura, Hiroaki

AU - Miyazaki, Masayuki

AU - Morita, Tatsuya

AU - Sugishita, Mihoko

AU - Kato, Hiroshi

AU - Murasaki, Yuka

AU - Gyawali, Bishal

AU - Kubo, Yoko

AU - Ando, Masahiko

AU - Kondo, Masashi

AU - Yamada, Kiyofumi

AU - Hasegawa, Yoshinori

AU - Ando, Yuichi

PY - 2018/3/1

Y1 - 2018/3/1

N2 - Background: Although opioid-induced nausea and vomiting (OINV) often result in analgesic undertreatment in patients with cancer, no randomized controlled trials have evaluated the efficacy of prophylactic antiemetics for preventing OINV. We conducted this randomized, placebo-controlled, double-blind trial to evaluate the efficacy and safety of prophylactic treatment with prochlorperazine for preventing OINV. Materials and Methods: Cancer patients who started to receive oral oxycodone were randomly assigned in a 1:1 ratio to receive either prochlorperazine 5 mg or placebo prophylactically, given three times daily for 5 days. The primary endpoint was the proportion of patients who had a complete response (CR) during the 120 hours of oxycodone treatment. CR was defined as no emetic episode and no use of rescue medication for nausea and vomiting during 5 days. Key secondary endpoints were the proportion of patients with emetic episodes, proportion of patients with moderate or severe nausea, quality of life, and proportion of treatment withdrawal. Results: From November 2013 through February 2016, a total of 120 patients were assigned to receive prochlorperazine (n = 60) or placebo (n = 60). There was no significant difference in CR rates (69.5% vs. 63.3%; p =.47) or any secondary endpoint between the groups. Patients who received prochlorperazine were more likely to experience severe somnolence (p =.048). Conclusion: Routine use of prochlorperazine as a prophylactic antiemetic at the initiation of treatment with opioids is not recommended. Further research is needed to evaluate whether other antiemetics would be effective in preventing OINV in specific patient populations. Implications for Practice: Prophylactic prochlorperazine seems to be ineffective in preventing opioid-induced nausea and vomiting (OINV) and may cause adverse events such as somnolence. Routine use of prophylactic prochlorperazine at the initiation of treatment with opioids is not recommended. Further research is needed to evaluate whether other antiemetics would be effective in preventing OINV in specific patient populations.

AB - Background: Although opioid-induced nausea and vomiting (OINV) often result in analgesic undertreatment in patients with cancer, no randomized controlled trials have evaluated the efficacy of prophylactic antiemetics for preventing OINV. We conducted this randomized, placebo-controlled, double-blind trial to evaluate the efficacy and safety of prophylactic treatment with prochlorperazine for preventing OINV. Materials and Methods: Cancer patients who started to receive oral oxycodone were randomly assigned in a 1:1 ratio to receive either prochlorperazine 5 mg or placebo prophylactically, given three times daily for 5 days. The primary endpoint was the proportion of patients who had a complete response (CR) during the 120 hours of oxycodone treatment. CR was defined as no emetic episode and no use of rescue medication for nausea and vomiting during 5 days. Key secondary endpoints were the proportion of patients with emetic episodes, proportion of patients with moderate or severe nausea, quality of life, and proportion of treatment withdrawal. Results: From November 2013 through February 2016, a total of 120 patients were assigned to receive prochlorperazine (n = 60) or placebo (n = 60). There was no significant difference in CR rates (69.5% vs. 63.3%; p =.47) or any secondary endpoint between the groups. Patients who received prochlorperazine were more likely to experience severe somnolence (p =.048). Conclusion: Routine use of prochlorperazine as a prophylactic antiemetic at the initiation of treatment with opioids is not recommended. Further research is needed to evaluate whether other antiemetics would be effective in preventing OINV in specific patient populations. Implications for Practice: Prophylactic prochlorperazine seems to be ineffective in preventing opioid-induced nausea and vomiting (OINV) and may cause adverse events such as somnolence. Routine use of prophylactic prochlorperazine at the initiation of treatment with opioids is not recommended. Further research is needed to evaluate whether other antiemetics would be effective in preventing OINV in specific patient populations.

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