Improvement of Quality of Life by Cannabinoids in Oncologic Patients

Study acronym: BELCANTO
StatusTerminated
PhasePhase 2
Started

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Record History

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  1. Trial terminated Sponsor's reason: Given the current recruitment rate and the changes in the treatment landscape, there is no reasonable expectation of achieving the planned sample size. Show 7 more changesShow less
    • Final enrollment: 79 participants (planned 170)
    • Primary completion date changed from estimate of Nov 30, 2026 to Feb 5, 2026
    • Study sites: 4 to 3
    • Interventions: Cannabisextrakt Avextra 10/10 Lösung (Drug) to Cannabisextrakt Avextra 10/10 Lösung (Drug)
    • Eligibility criteria expanded, about 12 words
    • Secondary endpoints: details revised at 2 of 12 entries
    • Study description expanded, about 5 words
  2. Phase: Phase 2/3 to Phase 2
    • Eligibility criteria expanded, about 48 words
    v3
  3. Trial status: Not Yet Recruiting to Recruitingv2 Show 4 more changesShow less
    • Start date changed from estimate of Dec 1, 2023 to Apr 8, 2024
    • Study sites: 3 to 4
    • Secondary endpoints: details revised at 3 of 12 entries
    • Study description expanded, about 188 words
  4. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
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.
Trial Details
NCT Number NCT06097533
Lead Sponsor University Hospital Schleswig-Holstein
Collaborators: Avextra Pharma GmbH, SocraMetrics GmbH
Conditions
(from sponsor)		 Medical Oncology, Palliative Care, Quality of Life, Cannabinoids
Enrollment 79 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov