Improvement of Quality of Life by Cannabinoids in Oncologic Patients

NCT ID: NCT06097533

Last Updated: 2024-10-26

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: PHASE2
• Total Enrollment: 170 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-04-08
• Study Completion Date: 2026-11-30

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.

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

Conditions

Medical Oncology; Palliative Care; Quality of Life; Cannabinoids

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

Cannabisextrakt Avextra 10/10 Lösung

Solution with tetrahydrocannabinol and cannabidiol

Group Type: EXPERIMENTAL

Cannabisextrakt Avextra 10/10 Lösung

Intervention Type: DRUG

medical cannabinoids

Placebo

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

Group Type: PLACEBO_COMPARATOR

Cannabisextrakt Avextra 10/10 Lösung

Intervention Type: DRUG

medical cannabinoids

Interventions

Cannabisextrakt Avextra 10/10 Lösung

medical cannabinoids

Intervention Type: DRUG

Other Intervention Names

Cannabisextrakt Avextra 10/10 solution

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

• Minimum Eligible Age: 25 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Avextra Pharma GmbH

UNKNOWN

Sponsor Role: collaborator

SocraMetrics GmbH

INDUSTRY

Sponsor Role: collaborator

University Hospital Schleswig-Holstein

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Hubertus Wald Tumorzentrum Universitäres Cancer Center Hamburg (UCCH)

Hamburg, City state of Hamburg, Germany

Site Status: RECRUITING

University Hospital Schleswig-Holstein

Kiel, Schleswig-Holstein, Germany

Site Status: RECRUITING

University Hospital Schleswig-Holstein

Kiel, Schleswig-Holstein, Germany

Site Status: RECRUITING

University Hospital Schleswig-Holstein

Lübeck, Schleswig-Holstein, Germany

Site Status: RECRUITING

Countries

Germany

Central Contacts

Justus Domschikowski, M.D.

Role: CONTACT

Justus.Domschikowski@uksh.de

0431500 ext. 26511

Thomas Herdegen, Prof.

Role: CONTACT

Thomas.Herdegen@uksh.de

0431500 ext. 30402

Facility Contacts

Matthias Rostock, M.D.

Role: primary

m.rostock@uke.de

+4940 7410 ext. 52490

Marianne Sinn, M.D.

Role: backup

ma.sinn@uke.de

Justus Domschikowski, M.D.

Role: primary

Justus.Domschikowski@uksh.de

0431 500 ext. 26511

Claudia Schmalz, M.D.

Role: backup

Claudia.Schmalz@uksh.de

Anne Letsch, Prof.

Role: primary

Anne.Letsch@uksh.de

0431500 ext. 22510

Bjoern N Heydrich, M.D.

Role: backup

Bjoern.Heydrich@uksh.de

0431500 ext. 22513

Franziska Hamm, M.D.

Role: primary

AnnaFranziska.Hamm@uksh.de

0451 500 ext. 44195

Kim Luley, M.D.

Role: backup

Kim.Luley@uksh.de

Other Identifiers

2022-004137-39

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

DRKS00031009

Identifier Type: REGISTRY

Identifier Source: secondary_id

BELCANTO

Identifier Type: -

Identifier Source: org_study_id