NCT05315999

Protreat-Trial: Prophylactic Antiemetic Treatment of Opioid-induced Nausea and Vomiting (OINV) in Palliative Care

Protreat-Trial: Prophylactic Antiemetic Treatment of Opioid-induced Nausea and Vomiting (OINV) in Palliative Care: a Randomized Controlled Phase II Feasibility Trial

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 30 (actual)
• Sponsor: Gerhild Becker · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

Palliative cancer patients with tumor pain often suffer from nausea and vomiting when starting pain therapy with opioids. The objective of the clinical pilot trial is to evaluate the efficacy and tolerability of palonosetron in the prophylactic treatment of opioid-induced nausea and vomiting.

Detailed description

Pain is one of the most common and debilitating symptoms in patients with advanced cancer and opioids are the main stay of treatment for cancer pain. However, initiation of opioid-therapy is frequently hindered by OINV. OINV is a highly distressing symptom and can affect medication compliance, enteral absorption, and quality of life.This Phase II feasibility study is conducted to assess the feasibility of the prophylactic antiemetic treatment of OINV with palonosetron in comparison to placebo. The objective is to investigate the feasibility of patient recruitment and implementation of the study design as well as to obtain an initial estimate of the antiemetic efficacy and safety of prophylactic treatment of OINV with palonosetron compared to placebo. A total of 30 palliative patients starting an opioid-therapy (WHO II \& III) for cancer pain will be randomly assigned to receive either a single dose of placebo or palonosetron. Safety and efficiency assessment are based on patient reports regarding OINV, pain and safety parameters during the following 6 days.

Conditions

• Nausea
• Vomiting
• Pain
• Advanced Cancer

Interventions

Type	Name	Description
DRUG	Palonosetron Hydrochloride	Palonosetron (500µg): single dose per os 1-2 hours before the start of opioid-therapy (WHO II \& III)
DRUG	Placebo	Placebo: single dose per os 1-2 hours before the start of opioid-therapy (WHO II \& III)

Timeline

• Start date: 2022-05-03
• Primary completion: 2024-12-18
• Completion: 2024-12-18
• First posted: 2022-04-07
• Last updated: 2025-03-19

Locations

1 site across 1 country: Germany