Clinical trial NCT06097533: Improvement of Quality of Life by Cannabinoids in Oncologic Patients
Official title: Improvement of Quality of Life by Cannabinoids in Oncologic Patients (BEfindLichkeitsverbesserung Unter CANnabinoid-ExtrakTen Bei Onkologischen Patienten)
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE2
Conditions: Medical Oncology
Palliative Care
Quality of Life
Cannabinoids
Keywords: BELCANTO
Lead sponsor: University Hospital Schleswig-Holstein
Sponsor class: OTHER
Collaborators: name: Avextra Pharma GmbH
name: SocraMetrics GmbH
First posted: 2023-10-24
Enrollment: 170
Sex: ALL
Minimum age (years): 25
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
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

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

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

Primary outcomes:
measure: ESAS-TSDS score
timeFrame: 12 days
Secondary outcomes:
measure: Global Patient's Assessment
timeFrame: 12 days, 4 weeks, 8 weeks
measure: opioid dose as morphine equivalent
timeFrame: 12 days, 4 weeks, 8 weeks
measure: defined daily dosages (DDD) of neuropharmaceuticals
timeFrame: 12 days, 4 weeks, 8 weeks
measure: ESAS-TSDS score
timeFrame: 4 weeks, 8 weeks
measure: inappetence
timeFrame: 12 days, 4 weeks, 8 weeks
measure: NCCN distress thermometer
timeFrame: 12 days, 4 weeks, 8 weeks
measure: pain as VAS
timeFrame: 12 days, 4 weeks, 8 weeks
measure: sleep quality (Pittsburgh Sleep Quality Index, PSQI)
timeFrame: 12 days, 4 weeks, 8 weeks
measure: EORTC QLQ-C15 PAL
timeFrame: 12 days, 4 weeks, 8 weeks
measure: Adverse events (AE)
timeFrame: up to 8 weeks
measure: C-reactive protein (CRP)
timeFrame: 12 days, 4 weeks, 8 weeks
measure: 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
timeFrame: 12 days, 4 weeks, 8 weeks
Other outcomes:
Locations:
city: Kiel
country: Germany
facility: University Hospital Schleswig-Holstein
state: Schleswig-Holstein
city: Kiel
country: Germany
facility: University Hospital Schleswig-Holstein
state: Schleswig-Holstein
city: Lübeck
country: Germany
facility: University Hospital Schleswig-Holstein
state: Schleswig-Holstein
city: Hamburg
country: Germany
facility: Hubertus Wald Tumorzentrum Universitäres Cancer Center Hamburg (UCCH)
Study officials:
References: