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Improvement of Quality of Life by Cannabinoids in Oncologic Patients

NCT06097533 · Status: RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 170

Last updated 2024-10-26

No results posted yet for this study

Summary

The goal is to explore whether the application of cannabis extract Avextra 10/10 solution is suitable to contribute to an improvement in the symptom burden and well-being of oncological palliative care patients. The primary objective of the study is to demonstrate the improvement in global symptom burden in the intervention arm compared to the placebo control group over a period of 12±2 days, as measured by a percentage change in the value of the Edmonton Symptom Assessment System total symptom distress score (ESAS TSDS) at baseline and after 12±2 days.

Conditions

  • Medical Oncology
  • Palliative Care
  • Quality of Life
  • Cannabinoids

Interventions

DRUG

Cannabisextrakt Avextra 10/10 Lösung

medical cannabinoids

Sponsors & Collaborators

  • Avextra Pharma GmbH

    collaborator UNKNOWN

  • SocraMetrics GmbH

    collaborator INDUSTRY

  • University Hospital Schleswig-Holstein

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
25 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-04-08
Primary Completion
2026-11-30
Completion
2026-11-30

Countries

  • Germany

Study Locations

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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 NCT06097533 on ClinicalTrials.gov