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

NCT05315999 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 30

Last updated 2025-03-19

No results posted yet for this study

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.

Conditions

Interventions

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)

Sponsors & Collaborators

  • Gerhild Becker

    lead OTHER

Principal Investigators

  • Gerhild Becker, Prof. Dr. med. · Clinic for Palliative Care, Medical Center, University of Freiburg, Germany

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-05-03
Primary Completion
2024-12-18
Completion
2024-12-18

Countries

  • Germany

Study Locations

More Related Trials

Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05315999 on ClinicalTrials.gov