NCT06097533

Brief 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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
170

participants targeted

Target at P75+ for phase_2

Timeline
7mo left

Started Apr 2024

Geographic Reach
1 country

4 active sites

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress79%
Apr 2024Nov 2026

First Submitted

Initial submission to the registry

October 18, 2023

Completed
6 days until next milestone

First Posted

Study publicly available on registry

October 24, 2023

Completed
6 months until next milestone

Study Start

First participant enrolled

April 8, 2024

Completed
2.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 30, 2026

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 30, 2026

Last Updated

October 26, 2024

Status Verified

October 1, 2024

Enrollment Period

2.6 years

First QC Date

October 18, 2023

Last Update Submit

October 23, 2024

Conditions

Medical OncologyPalliative CareQuality of LifeCannabinoids

Keywords

BELCANTO

Outcome Measures

Primary Outcomes (1)

  • ESAS-TSDS score

    Symptom change as percentage change in ESAS-TSDS score after 12±2 days compared to baseline between intervention group and placebo control group.

    12 days

Secondary Outcomes (12)

  • Global Patient's Assessment

    12 days, 4 weeks, 8 weeks

  • opioid dose as morphine equivalent

    12 days, 4 weeks, 8 weeks

  • defined daily dosages (DDD) of neuropharmaceuticals

    12 days, 4 weeks, 8 weeks

  • ESAS-TSDS score

    4 weeks, 8 weeks

  • inappetence

    12 days, 4 weeks, 8 weeks

  • +7 more secondary outcomes

Study Arms (2)

Cannabisextrakt Avextra 10/10 Lösung

EXPERIMENTAL

Solution with tetrahydrocannabinol and cannabidiol

Drug: Cannabisextrakt Avextra 10/10 Lösung

Placebo

PLACEBO COMPARATOR

Sesame oil, Ph.Eur. Linseed oil, Ph.Eur

Drug: Cannabisextrakt Avextra 10/10 Lösung

Interventions

Cannabisextrakt Avextra 10/10 LösungDRUG

medical cannabinoids

Also known as: Cannabisextrakt Avextra 10/10 solution
Cannabisextrakt Avextra 10/10 LösungPlacebo

Eligibility Criteria

Age25 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • ≥25 years old and legally competent
  • Palliative oncological therapy
  • ECOG status 1, 2 or 3, incapacitated for work
  • ESAS TSDS \> or equals 16
  • Nutritional Risk Screening \> or equals 3
  • Pain numerical rating scale \> or equals 4
  • informed consent
  • for WOCBP:
  • Negative pregnancy test
  • Reliable contraception (Pearl Index \< 1%)

You may not qualify if:

  • nausea \> or equals grade 3 (CTCAE) or vomiting \> or equals grade 2 (CTCAE) in the preceding week
  • Inability to understand and complete the questionnaires
  • Cannabis use in the last 6 weeks
  • Alcohol addiction
  • Pregnancy/lactation
  • Contraindications or intolerance to the study medication (esp. psychosis)
  • Simultaneous participation in other clinical studies (sumulataneous participation in non-interventional studies (i.e. biomarker-studies, registries) is allowed, if the study-aim does not interfere with measures of the second study)
  • Any other condition as judged by the investigator, e.g. non-compliance

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (4)

Hubertus Wald Tumorzentrum Universitäres Cancer Center Hamburg (UCCH)

Hamburg, Hamburg, 20246, Germany

RECRUITING

University Hospital Schleswig-Holstein

Kiel, Schleswig-Holstein, 24105, Germany

RECRUITING

University Hospital Schleswig-Holstein

Kiel, Schleswig-Holstein, 24105, Germany

RECRUITING

University Hospital Schleswig-Holstein

Lübeck, Schleswig-Holstein, Germany

RECRUITING

Central Study Contacts

Justus Domschikowski, M.D.

CONTACT

0431500Justus.Domschikowski@uksh.de

Thomas Herdegen, Prof.

CONTACT

0431500Thomas.Herdegen@uksh.de

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Masking Details
IMPs are centrally blinded and randomised at the pharmacy.
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: Multi-center, prospective, interventional, randomized, two-arm, placebo-controlled, parallel, double-blinded clinical trial according to German Drug Law (AMG)/GCP and German Narcotic Drugs Act (BtMG)
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 18, 2023

First Posted

October 24, 2023

Study Start

April 8, 2024

Primary Completion (Estimated)

November 30, 2026

Study Completion (Estimated)

November 30, 2026

Last Updated

October 26, 2024

Record last verified: 2024-10

Locations

DE(4)