Clinical Trials Logo

Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT06097533
Other study ID # BELCANTO
Secondary ID 2022-004137-39DR
Status Not yet recruiting
Phase Phase 2/Phase 3
First received
Last updated
Start date December 1, 2023
Est. completion date November 30, 2026

Study information

Verified date October 2023
Source University Hospital Schleswig-Holstein
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical 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. 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.


Recruitment information / eligibility

Status Not yet recruiting
Enrollment 170
Est. completion date November 30, 2026
Est. primary completion date November 30, 2026
Accepts healthy volunteers No
Gender All
Age group 25 Years and older
Eligibility 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 - 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

Study Design


Related Conditions & MeSH terms


Intervention

Drug:
Cannabisextrakt Avextra 10/10 Lösung
medical cannabinoids

Locations

Country Name City State
Germany Hubertus Wald Tumorzentrum Universitäres Cancer Center Hamburg (UCCH) Hamburg
Germany University Hospital Schleswig-Holstein Kiel Schleswig-Holstein
Germany University Hospital Schleswig-Holstein Lübeck Schleswig-Holstein

Sponsors (3)

Lead Sponsor Collaborator
University Hospital Schleswig-Holstein Avextra Pharma GmbH, SocraMetrics GmbH

Country where clinical trial is conducted

Germany, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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 Global Patient's Assessment 12 days, 4 weeks, 8 weeks
Secondary opioid dose as morphine equivalent 12 days, 4 weeks, 8 weeks
Secondary defined daily dosages (DDD) of neuropharmaceuticals 12 days, 4 weeks, 8 weeks
Secondary ESAS-TSDS score 4 weeks, 8 weeks
Secondary inappetence 12 days, 4 weeks, 8 weeks
Secondary NCCN distress thermometer 12 days, 4 weeks, 8 weeks
Secondary pain as VAS 12 days, 4 weeks, 8 weeks
Secondary sleep quality (Pittsburgh Sleep Quality Index, PSQI) 12 days, 4 weeks, 8 weeks
Secondary EORTC QLQ-C15 PAL European Organization for Research and Treatment of Cancer Quality of Life Palliative 12 days, 4 weeks, 8 weeks
Secondary 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) up to 8 weeks
Secondary C-reactive protein (CRP) 12 days, 4 weeks, 8 weeks
Secondary 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 12 days, 4 weeks, 8 weeks
See also
  Status Clinical Trial Phase
Active, not recruiting NCT05559255 - Changes in Pain, Spasticity, and Quality of Life After Use of Counterstrain Treatment in Individuals With SCI N/A
Completed NCT06238557 - Prospective Evaluation of Psychological Consequences and Impact on Long-term Quality of Life
Recruiting NCT05563805 - Exploring Virtual Reality Adventure Training Exergaming N/A
Completed NCT05472935 - Asynchronous Mindfulness Based Stress Reduction to Reduce Burnout in Licensed Clinical Social Workers N/A
Recruiting NCT04444544 - Quality of Life and High-Risk Abdominal Cancer Surgery
Completed NCT04281953 - Impact on Quality of Life of Long-term Ototoxicity in Cancer Survivors
Recruiting NCT05546931 - Mobile Health Program for Rural Hypertension N/A
Active, not recruiting NCT04746664 - Effects of Nutrition Counselling on Old Age People's Nutritional Status and Quality of Life in Bahir Dar City, North West Ethiopia N/A
Completed NCT05387174 - Nursing Intervention in Two Risk Factors of the Metabolic Syndrome and Quality of Life in the Climacteric Period N/A
Recruiting NCT04142827 - The Effect of Long Term Therapy With High Flow Humidification Compared to Usual Care in Patients With Bronchiectasis (BX) N/A
Active, not recruiting NCT05903638 - A Pilot RCT: the Impact of a Virtual MBSR Course on Women With Primary Infertility N/A
Completed NCT05538455 - Investigating ProCare4Life Impact on Quality of Life of Elderly Subjects With Neurodegenerative Diseases N/A
Completed NCT06216015 - Exercise Training and Kidney Transplantation N/A
Completed NCT03813420 - Sleep Quality of Physiotherapy Students Quality of Life and Physical Activity Level N/A
Recruiting NCT05550545 - Infant RSV Infections and Health-related Quality of Life of Families
Completed NCT05346588 - THRIVE Feasibility Trial Phase 3
Recruiting NCT05233020 - Robotic Versus Hybrid Assisted Ventral Hernia Repair N/A
Terminated NCT03304184 - The Role of Biodentine in Class V Dental Lesions on Oral Health Related Quality of Life Phase 3
Completed NCT05063305 - Probiotics, Immunity, Stress, and QofL N/A
Recruiting NCT05380856 - Sacral Neuromodulation for Neurogenic Lower Urinary Tract, Bowel and Sexual Dysfunction N/A