Improvement of Quality of Life by Cannabinoids in Oncologic Patients (BELCANTO)

Overview

Sponsor-declared trial summary

Key facts

Sponsor

Universitaetsklinikum Schleswig-Holstein AöR

Participant type

Patients

Age range

18-64 years

Gender

Male and Female

Therapeutic area

Not possible to specify, Diseases [C] - Pathological Conditions, Signs and Symptoms [C23]

Trial duration

8 Nov 2023 → 19 Feb 2026

Decision date (initial)

2024-11-04

Transition trial

Yes

Low-intervention

No

Rare-disease indication

No

Vulnerable population

No

Funding sources

AVEXTRA Pharma GmbH, 10707 Berlin, Germany

External identifiers

EU CT number

2024-518917-24-00

EudraCT number

2022-004137-39

ClinicalTrials.gov

NCT06097533

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

Scope: Others

Proof of improvement of global symptom-burden in comparison to placebo-controlgroup in a timeframe of 12 +/- days, measured by a comparison of the Edmonton Symptom Assessment System total symptom distress score (ESAS TSDS) –rating at the time of study-start and after 12 +/- 2 days. The results of the clinical trial shall generate evidence for the use of Cannabisextract Avextra 10/10 solution in palliative oncology an das a basis for planning future trials in this field.

Secondary objectives 1

1. Global Patient’s Assessment (GPA) Change of the morphin-equivalent-dosage during the trial Change (number + defined daily dosage of other (indirect) analgetic drugs (timepoints vs. baseline) Symptomchange (change of ESAS-TSDS-rating) (timepoints vs. baseline) Change disappetence (timepoints vs. baseline) Change NCCN-Distress-Thermometer (timepoints vs. baseline) + 6 others

Conditions and MedDRA coding

oncology, palliative care, quality of life

Eligibility criteria

Principal inclusion / exclusion criteria as submitted by sponsor

Inclusion criteria 8

1. 25 years or older and legally able
2. palliative-oncological therapy
3. ECOG status 1, 2 or 3, unable to work
4. Nutritional Risk Screening ≥ 3
5. Pain numerical rating scale ≥ 4
6. informed consent
7. if WOCBP: negative pregnancytest, safe contraception (Pearl Index < 1%)
8. ESAS TSDS (item 1-8) ≥ 16

Exclusion criteria 9

1. Sickness ≥ grade 3 (CTCAE) or vomitting ≥ grad 2 (CTCAE) in preceding week (exclusioncriterium only)
2. Disability to understand and fill out the questionaires
3. Use of cannabis in the last 6 months
4. alcoholaddiction
5. pregnancy/ breastfeeding
6. contraindicationen or intolerance of IMP
7. bloodpressure systolic <100 mgHg or diastolic <60 mmHg
8. simultaneous participation in other clinical trials; participation in non-interventional trials is in general allowed
9. Any other condition due to judgement of investigator (i.e. Non-Compliance)

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 1

1. Change of symptoms as change of the ESAS-TSDS-rating after 12+/- days in comparison to baseline between the intervention-group and placebo-group.

Secondary endpoints 12

1. Global Patient’s Assessment (GPA)
2. Absolute and relative change the opioid-dosage (prescribed independently according to standard of care/ freedom of therapy) as morphin-aequivalent-dosing in the course of the trial between the groups (interventional and placebo-group) )
3. Change in count and defined daily dosage (DDD) of other analgetic drugs (direct or indirect) like NSAID, Glucocorticoids, neuropharmaceutics at the timepoint of capture in comparison to baseline between the groupsbaseline)
4. Symptomchange (change of ESAS-TSDS-rating) at the timepoints of capture in comparison to baseline between the groupsvs. baseline) Change disappetence (timepoints vs. baseline) Change NCCN-Distress-Thermometer (timepoints vs. baseline)
5. Change disappetence (visual analog-scale) at the timepoints of capture in comparison to baseline between the groups
6. Changeof NCCN-Distress-Thermometer at the timepoint sof capture in comparison to baseline between the groups
7. Change of pain (numerical rating scale) at the timeppoints of capturte in comparsion to baselin between the groups
8. Change of quality of sleep (Pittsburgh sleepauality index, PSQI) at the timepoints of capture in comparison to bseline betweent he groups
9. Change of the result of an Quality-Of-Life-Questionaire (European Organsation for Research and Treatment of Cancer Quality of Life Palliativ, EORTC QLQ-C15 PAL) at the timepoints of capture in comparison to baseline and between the groups
10. Appearence, frequence and severity of Adverse Events (AE) coded according to Medical Dictionalry for Regulatory Activities (MeDRA) and evaluated follwing NCI Common Terminology Criteria for Adverse Events (CTCAE) and and comparison between the groups
11. Absolute value and change of plasmaconcentration of C-reacive protein (CRP) in comparison to baseline between the groups (derived from routine samples according to standard-of-care).
12. Stratified evaluation of the analyses named above, according to kind and stadium of the oncological disease (ICD-10), way of treatment, sex, weight, high-/low-dose and age.

Investigational products

Investigational medicinal products (IMPs), comparators, placebo, auxiliary

Test 1

Placebo 1

Sponsors and contacts

Sponsor organisations, regulatory contacts, third parties

Universitaetsklinikum Schleswig-Holstein AöR

Sponsor organisation

Universitaetsklinikum Schleswig-Holstein AöR

Address

Arnold-Heller-Strasse 3, Brunswik Brunswik

City

Kiel

Postcode

24105

Country

Germany

Scientific contact point

Organisation

Universitaetsklinikum Schleswig-Holstein AöR

Contact name

Prof. Thomas Herdegen

Public contact point

Organisation

Universitaetsklinikum Schleswig-Holstein AöR

Contact name

Prof. Thomas Herdegen

Locations

1 EU/EEA country · 7 investigational sites

By country

Investigational sites

Country notifications

Trial-start, recruitment-start, end and early-termination notifications submitted per Member State

Results and documents

Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial

Documents 13 files

Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.

Application history

3 submissions — initial application plus substantial / non-substantial modifications