Trial Title:
Improvement of Quality of Life by Cannabinoids in Oncologic Patients
NCT ID:
NCT06097533
Condition:
Medical Oncology
Palliative Care
Quality of Life
Cannabinoids
Conditions: Keywords:
BELCANTO
Study type:
Interventional
Study phase:
Phase 2
Overall status:
Recruiting
Study design:
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)
Primary purpose:
Treatment
Masking:
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Masking description:
IMPs are centrally blinded and randomised at the pharmacy.
Intervention:
Intervention type:
Drug
Intervention name:
Cannabisextrakt Avextra 10/10 Lösung
Description:
medical cannabinoids
Arm group label:
Cannabisextrakt Avextra 10/10 Lösung
Arm group label:
Placebo
Other name:
Cannabisextrakt Avextra 10/10 solution
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.
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
Criteria for eligibility:
Criteria:
Inclusion Criteria:
- ≥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%)
Exclusion Criteria:
- 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
Gender:
All
Minimum age:
25 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
University Hospital Schleswig-Holstein
Address:
City:
Kiel
Zip:
24105
Country:
Germany
Status:
Recruiting
Contact:
Last name:
Justus Domschikowski, M.D.
Phone:
0431 500
Phone ext:
26511
Email:
Justus.Domschikowski@uksh.de
Contact backup:
Last name:
Claudia Schmalz, M.D.
Email:
Claudia.Schmalz@uksh.de
Facility:
Name:
University Hospital Schleswig-Holstein
Address:
City:
Kiel
Zip:
24105
Country:
Germany
Status:
Recruiting
Contact:
Last name:
Anne Letsch, Prof.
Phone:
0431500
Phone ext:
22510
Email:
Anne.Letsch@uksh.de
Contact backup:
Last name:
Bjoern N Heydrich, M.D.
Phone:
0431500
Phone ext:
22513
Email:
Bjoern.Heydrich@uksh.de
Facility:
Name:
University Hospital Schleswig-Holstein
Address:
City:
Lübeck
Country:
Germany
Status:
Recruiting
Contact:
Last name:
Franziska Hamm, M.D.
Phone:
0451 500
Phone ext:
44195
Email:
AnnaFranziska.Hamm@uksh.de
Contact backup:
Last name:
Kim Luley, M.D.
Email:
Kim.Luley@uksh.de
Facility:
Name:
Hubertus Wald Tumorzentrum Universitäres Cancer Center Hamburg (UCCH)
Address:
City:
Hamburg
Zip:
20246
Country:
Germany
Status:
Recruiting
Contact:
Last name:
Matthias Rostock, M.D.
Phone:
+4940 7410
Phone ext:
52490
Email:
m.rostock@uke.de
Contact backup:
Last name:
Marianne Sinn, M.D.
Email:
ma.sinn@uke.de
Start date:
April 8, 2024
Completion date:
November 30, 2026
Lead sponsor:
Agency:
University Hospital Schleswig-Holstein
Agency class:
Other
Collaborator:
Agency:
Avextra Pharma GmbH
Agency class:
Other
Collaborator:
Agency:
SocraMetrics GmbH
Agency class:
Industry
Source:
University Hospital Schleswig-Holstein
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06097533
