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

NCT05315999 | Completed Phase 2

• 1 other identifier: P003161
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief 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

Nausea; Vomiting; Pain; Advanced Cancer

Outcome Measures

Primary Outcomes (2)

• Feasibility of the study design

  Rates of patient recruitment per month, screening failures, drop-out from the trial.

  12 months

• Number of patients who show no relevant increase of nausea

  Number of patients who show no relevant increase of nausea after starting opioid therapy at any of the following 6 days. Nausea scores are assessed on an increasing 11-point numeric rating scale (NRS) from 0 to 10, 0 meaning that the symptom is absent and 10 that it is of the worst possible severity according to the Edmonton Symptom Assessment Schedule (ESAS). Relevant is an increase on this NRS ≥1, which reflects the minimal clinically important difference (MCID) for nausea

  day 1 to day 6

Secondary Outcomes (11)

• Complete response of OINV

  day 1 to day 6

• Time to OINV

  day 1 to day 6

• Nausea

  day 1 to day 6

• Vomiting

  day 1 to day 6

• Pain control

  day 1 to day 6

Study Arms (2)

Palonosetron Hydrochloride

EXPERIMENTAL

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

Drug: Palonosetron Hydrochloride

Placebo

PLACEBO COMPARATOR

Placebo: single dose per os 1-2 hours before the start of opioid-therapy (WHO II \& III)

Drug: Placebo

Interventions

Palonosetron Hydrochloride DRUG

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

Palonosetron Hydrochloride

Placebo DRUG

Placebo: single dose per os 1-2 hours before the start of opioid-therapy (WHO II \& III)

Placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients aged ≥18 years
• Opioid naïve (no opioids intake within last 72 hours) patients in whom opioid therapy (WHO II \& III) is started to treat cancer pain;
• Palliative (not curable) cancer pain patients;
• Patients must have a score for nausea on a 0-10 numeric rating scale (NRS) \< 3 at screening visit;
• Written informed consent obtained according to international guidelines and local laws;
• Ability of patient to understand nature, importance, and individual consequences of clinical trial;
• Patients must be able to adhere to the study visit schedule and other protocol requirements.

You may not qualify if:

• Patient's death is imminent (judged by the "surprise" question of the treating physician or nurse: "Would you be surprised if this patient died within the next 7 days?"); If the answer is "no", trial subject cannot participate;
• Participation in the trial considered inappropriate based on the patient's physical, social, psychological, or spiritual condition (judgement of treating physician or nurse);
• Patients receiving antiemetic treatment within the last 72 h before study treatment period
• Patients if they are known to start a treatment causing acute nausea and/or emesis during study period
• Patients with contraindications or hypersensitivity to opioids or palonosetron, fructose, soya, lactose or peanut intolerance;
• Patients unable to take oral medications or patients receiving medication via PEG-tube;
• Patients undergoing dialyses treatment;
• Known or persistent abuse of medication, drugs, or alcohol;
• Current or planned pregnancy, nursing period;
• Patients who are sexually active and unwilling to use highly effective contraceptive methods. The following contraceptive methods with a Pearl Index lower than 1% are regarded as highly effective:
• Oral hormonal contraception ('pill')
• Dermal hormonal contraception
• Vaginal hormonal contraception (NuvaRing®)
• Contraceptive plaster
• Long-acting injectable contraceptives

Sponsors & Collaborators

• Gerhild Becker: lead

Study Sites (1)

Clinic for Palliative Care, Medical Center, University of Freiburg

Freiburg im Breisgau, D-79106, Germany

Location

MeSH Terms

Conditions

Nausea; Vomiting; Pain

Interventions

Palonosetron

Condition Hierarchy (Ancestors)

Signs and Symptoms, Digestive; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Neurologic Manifestations

Intervention Hierarchy (Ancestors)

Quinuclidines; Heterocyclic Compounds, Bridged-Ring; Heterocyclic Compounds; Isoquinolines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring

Study Officials

• Gerhild Becker, Prof. Dr. med.

  Clinic for Palliative Care, Medical Center, University of Freiburg, Germany

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Prof. Dr. med.

Study Record Dates

• First Submitted: March 2, 2022
• First Posted: April 7, 2022
• Study Start: May 3, 2022
• Primary Completion: December 18, 2024
• Study Completion: December 18, 2024
• Last Updated: March 19, 2025

Record last verified: 2024-12

Data Sharing

• IPD Sharing: Will not share

Locations

DE (1)