Improvement of Quality of Life by Cannabinoids in Oncologic Patients (BELCANTO)
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ClinicalTrials.gov Identifier: NCT06097533 |
Recruitment Status :
Not yet recruiting
First Posted : October 24, 2023
Last Update Posted : October 24, 2023
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Medical Oncology Palliative Care Quality of Life Cannabinoids | Drug: Cannabisextrakt Avextra 10/10 Lösung | Phase 2 Phase 3 |
Study Type : | Interventional (Clinical Trial) |
Estimated Enrollment : | 170 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Intervention 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 (Participant, Care Provider, Investigator, Outcomes Assessor) |
Masking Description: | IMPs are centrally blinded and randomised at the pharmacy. |
Primary Purpose: | Treatment |
Official Title: | Improvement of Quality of Life by Cannabinoids in Oncologic Patients (BEfindLichkeitsverbesserung Unter CANnabinoid-ExtrakTen Bei Onkologischen Patienten) |
Estimated Study Start Date : | December 1, 2023 |
Estimated Primary Completion Date : | November 30, 2026 |
Estimated Study Completion Date : | November 30, 2026 |
Arm | Intervention/treatment |
---|---|
Experimental: Cannabisextrakt Avextra 10/10 Lösung
Solution with tetrahydrocannabinol and cannabidiol
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Drug: Cannabisextrakt Avextra 10/10 Lösung
medical cannabinoids |
Placebo Comparator: Placebo
Sesame oil, Ph.Eur. Linseed oil, Ph.Eur
|
Drug: Cannabisextrakt Avextra 10/10 Lösung
medical cannabinoids |
- ESAS-TSDS score [ Time Frame: 12 days ]Symptom change as percentage change in ESAS-TSDS score after 12±2 days compared to baseline between intervention group and placebo control group.
- Global Patient's Assessment [ Time Frame: 12 days, 4 weeks, 8 weeks ]
- opioid dose as morphine equivalent [ Time Frame: 12 days, 4 weeks, 8 weeks ]
- defined daily dosages (DDD) of neuropharmaceuticals [ Time Frame: 12 days, 4 weeks, 8 weeks ]
- ESAS-TSDS score [ Time Frame: 4 weeks, 8 weeks ]
- inappetence [ Time Frame: 12 days, 4 weeks, 8 weeks ]
- NCCN distress thermometer [ Time Frame: 12 days, 4 weeks, 8 weeks ]
- pain as VAS [ Time Frame: 12 days, 4 weeks, 8 weeks ]
- sleep quality (Pittsburgh Sleep Quality Index, PSQI) [ Time Frame: 12 days, 4 weeks, 8 weeks ]
- EORTC QLQ-C15 PAL [ Time Frame: 12 days, 4 weeks, 8 weeks ]European Organization for Research and Treatment of Cancer Quality of Life Palliative
- Adverse events (AE) [ Time Frame: up to 8 weeks ]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)
- C-reactive protein (CRP) [ Time Frame: 12 days, 4 weeks, 8 weeks ]
- 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 [ Time Frame: 12 days, 4 weeks, 8 weeks ]
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
Ages Eligible for Study: | 25 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- ≥25 years old and legally competent
- Palliative oncological therapy
- ECOG status 1, 2 or 3, incapacitated for work
- ESAS TSDS > 15
- Nutritional Risk Screening > 3
- Pain numerical rating scale > 3
- informed consent
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for WOCBP:
- Negative pregnancy test
- Reliable contraception (Pearl Index < 1%)
Exclusion Criteria:
- nausea/vomiting
- Inability to understand and complete the questionnaires
- Cannabis use in the last 2 years
- Alcohol addiction
- Pregnancy/lactation
- Contraindications or intolerance to the study medication
- Simultaneous participation in other clinical studies
- Any other condition as judged by the investigator, e.g. non-compliance
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT06097533
Germany | |
University Hospital Schleswig-Holstein | |
Kiel, Schleswig-Holstein, Germany, 24105 | |
Contact: Justus Domschikowski, M.D. | |
University Hospital Schleswig-Holstein | |
Lübeck, Schleswig-Holstein, Germany | |
Contact: Franziska Hamm, M.D. | |
Hubertus Wald Tumorzentrum Universitäres Cancer Center Hamburg (UCCH) | |
Hamburg, Germany, 20246 | |
Contact: Matthias Rostock, M.D. |
Responsible Party: | University Hospital Schleswig-Holstein |
ClinicalTrials.gov Identifier: | NCT06097533 |
Other Study ID Numbers: |
BELCANTO 2022-004137-39 ( EudraCT Number ) DRKS00031009 ( Registry Identifier: German Clinical Trials Register ) |
First Posted: | October 24, 2023 Key Record Dates |
Last Update Posted: | October 24, 2023 |
Last Verified: | October 2023 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | Undecided |
Plan Description: | Aggregated data can be shared. Individual data only after internal and IRB review. |
Studies a U.S. FDA-regulated Drug Product: | No |
Studies a U.S. FDA-regulated Device Product: | No |