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Medical OncologyPhase 2BELCANTONCT06097533

Improvement of Quality of Life by Cannabinoids in Oncologic Patients

A Phase 2 study testing Cannabisextrakt Avextra 10/10 Lösung in people with Medical Oncology and Palliative Care, run by University Hospital Schleswig-Holstein at 3 sites in Germany.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 25 years and older
Conditions the study is for
Medical Oncology, Palliative Care, Quality of Life
What is being tested?
Cannabisextrakt Avextra 10/10 Lösung
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
79 participants
Where
3 sitesGermany
Study dates
8 Apr 2024to 5 Feb 2026
Phase
Phase 2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 25 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • ≥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
Show all 10Show fewer
  • informed consent
  • for WOCBP:
  • Negative pregnancy test
  • Reliable contraception (Pearl Index < 1%)

Who cannot join

  • 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

Trial locations and contacts

3 sites in 1 country.

Germany3 sites

  • Hubertus Wald Tumorzentrum Universitäres Cancer Center Hamburg (UCCH)

    Hamburg, Free and Hanseatic City of Hamburg, 20246

  • University Hospital Schleswig-Holstein

    Kiel, Schleswig-Holstein, 24105

  • University Hospital Schleswig-Holstein

    Lübeck, Schleswig-Holstein

Other trials in Germany

About this study

Official title: Improvement of Quality of Life by Cannabinoids in Oncologic Patients (BEfindLichkeitsverbesserung Unter CANnabinoid-ExtrakTen Bei Onkologischen Patienten)

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.

Read the detailed description

170 oncological patients in palliative treatment will be randomized 1:1 to an THC:CBD-interventional arm and an placebo-arm. At the timepoints baseline, 12±2 days, 18±3 days, four weeks and eight weeks, the global burden of symptoms (ESAS TSDS), quality of life (EORTC QLQ C15 PAL) and other parameter will be measured and the intraindividual difference in comparison with the baseline will be compared between the groups. This study is intended to provide a significant contribution to Evidence-based medicine (EbM) of CAM in palliative medicine as well as for elderly and severely ill subjects (resp.) in general.

The following gain of knowledge is expected:

  • substancial and reliable effects of CAM in elderly subjects being in a multimorbid and psychologically very stressful situation of illness and life (resp.).
  • substancial and reliable effects of CAM in aduld subjects being in a oncologically and palliative situation of illness and life (resp.).
  • compatibility of a CAM-therapy in multimorbid patients with polypharmacotherapy.
  • importance of CAM for the very frequent psychovegetative disturbance and comorbidities of many illnesses like sleepnesness, loss of appetite, nausea, fear and affective disturbance.
  • possible reduction of costs and improved economics through CAM
Being tested
Cannabisextrakt Avextra 10/10 Lösung
Keywords
BELCANTO

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Cannabisextrakt Avextra 10/10 LösungDrug

    Also called Cannabisextrakt Avextra 10/10 solution

    medical cannabinoids

Study groups in NCT06097533
Study groupRoleWhat they receive
Cannabisextrakt Avextra 10/10 LösungExperimentalSolution with tetrahydrocannabinol and cannabidiol
Receives: Drug: Cannabisextrakt Avextra 10/10 Lösung
PlaceboPlacebo comparatorSesame oil, Ph.Eur. Linseed oil, Ph.Eur
Receives: Drug: Cannabisextrakt Avextra 10/10 Lösung

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: 12 days

Secondary outcomes (12)

  1. Global Patient's Assessment

    Scale to evaluate the absolute severity and the change in comparison with the preceding measurement

    Measured: 12 days, 4 weeks, 8 weeks

  2. opioid dose as morphine equivalent

    Measured: 12 days, 4 weeks, 8 weeks

  3. defined daily dosages (DDD) of neuropharmaceuticals

    Measured: 12 days, 4 weeks, 8 weeks

  4. ESAS-TSDS score

    Edmonton Symptom Assessment System

    Measured: 4 weeks, 8 weeks

  5. inappetence

    Measured: 12 days, 4 weeks, 8 weeks

  6. NCCN distress thermometer

    Measured: 12 days, 4 weeks, 8 weeks

  7. pain as VAS

    Measured: 12 days, 4 weeks, 8 weeks

  8. sleep quality (Pittsburgh Sleep Quality Index, PSQI)

    contains 19 self-rated questions and 5 questions rated by the bed partner or roommate (if one is available)

    Measured: 12 days, 4 weeks, 8 weeks

  9. EORTC QLQ-C15 PAL

    European Organization for Research and Treatment of Cancer Quality of Life Palliative

    Measured: 12 days, 4 weeks, 8 weeks

  10. Adverse events (AE)

    Adverse events (AE) incidence, frequency and severity coded according to the Medical Dictionary for Regulatory Activities (MedDRA) and scored according to the NCI Common Terminology Criteria for Adverse Events (CTCAE)

    Measured: up to 8 weeks

  11. C-reactive protein (CRP)

    Measured: 12 days, 4 weeks, 8 weeks

  12. all endpoints stratified by stage of oncological disease (ICD-10), treatment modalities, gender, weight, high/low dose, renal function and age whereever possible and meaningful

    Measured: 12 days, 4 weeks, 8 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted24 Oct 2023
  2. Study start8 Apr 2024
  3. Primary completion5 Feb 2026
  4. Study completion5 Feb 2026

Why it stopped: Given the current recruitment rate and the changes in the treatment landscape, there is no reasonable expectation of achieving the planned sample size.

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Model description
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)
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
79 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06097533
Sponsor's protocol ID
BELCANTO
Other IDs
2022-004137-39, DRKS00031009
Acronym
BELCANTO
Status last verified
Oct 2026
First submitted
18 Oct 2023
Last updated
16 Oct 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided: Aggregated data can be shared. Individual data only after internal and IRB review.

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Cannabisextrakt Avextra 10/10 Lösung in people with Medical Oncology and Palliative Care, run by University Hospital Schleswig-Holstein at 3 sites in Germany.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 10 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 16 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 3 sites in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study was stopped early (reason given: Given the current recruitment rate and the changes in the treatment landscape, there is no reasonable expectation of achieving the planned sample size.). Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

ESAS-TSDS score (time frame: 12 days). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06097533.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Oct 2026.

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