Cannabis extrAct in oncology Patients for the treatment of TUmor Related symptom burden (CAPTURE)

Overview

Sponsor-declared trial summary

Key facts

Sponsor

IRCCS Istituto Nazionale Tumori Fondazione Pascale

Participant type

Patients

Age range

18-64 years, 65+ years

Gender

Male and Female

Therapeutic area

Diseases [C] - Neoplasms [C04]

Decision date (initial)

2025-08-21

Transition trial

No

Low-intervention

No

Rare-disease indication

No

Vulnerable population

Yes

Funding sources

Avextra Pharma GmbH

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

Scope: Efficacy, Therapy

To asess the therapeutic add-on effect of the balanced THC/CBD extract (Cannabis extract Avextra 10/10 oral solution) on symptom burden in patients with advanced oncologic disease receiving active treatment with WHO level II or III opioids and adjuvants therapies, compared to placebo, as measured by the Edmonton Symptom Assessment System Total Symptom Distress Score (ESAS-TSDS) at 8 weeks post randomization.

Secondary objectives 1

1. To assess the impact of the therapeutic add-on of a balanced THC/CBD extract (Avextra 10/10 oral solution) in patients with advanced oncologic disease receiving active treatment with WHO step II or III opioids and adjuvant therapies, compared to placebo, in terms of: 1. Nutritional status at 8 weeks 2. Sleep quality at 8 weeks 3. Neuropathic pain at 8 weeks 4. Functional interference at 8 weeks 5. Severity of clinical symptoms assessed by ESAS subscores at 8 weeks 6. ESAS-TSDS response rate at 8 weeks 7. Adherence to antineoplastic therapies 8. Requirement for opioids and adjuvant therapies 9. Treatment tolerability 10. Feasibility of the intervention 11. Longitudinal changes in ESAS-TSDS and ESAS subscores 12. Longitudinal changes in nutritional status, sleep quality, neuropathic pain, and functional interference

Conditions and MedDRA coding

Patients with advanced oncologic disease receiving active treatment with WHO level II or III opioids and adjuvants therapies

Eligibility criteria

Principal inclusion / exclusion criteria as submitted by sponsor

Inclusion criteria 1

1. 1. Written informed consent 2. Individuals of any sex, gender, sexual orientation, and ethnicity aged 18 years or older 3. No prior use of cannabis within the past 6 months 4. Patients with advanced oncologic disease, life expectancy of at least 6 months, currently undergoing active antineoplastic treatment, and experiencing a clinically relevant impairment in quality of life, defined by the presence of at least one of the following: a. Physical symptoms such as moderate to severe pain, nausea, vomiting, anorexia, or fatigue b. Psychological symptoms such as anxiety, depression, or insomniaù 5. PS ECOG ≤ 3 6. ESAS-TSDS score ≥ 16 7. Patients on stable therapy with opioids classified as "Level II" or "Level III" according to the WHO analgesic scale and/or receiving adjuvant medications 8. Women of Childbearing Potential (WOCBP) are eligible for the study only if: a. Negative pregnancy test b. Requirement to use effective contraception (defined as the use of two methods with a Pearl Index < 1%)

Exclusion criteria 1

1. Patients will be considered ineligible if they meet any of the following criteria: 1. Inability to understand and complete the questionnaires 2. Known hypersensitivity/allergy to THC or CBD 3. Psychiatric disorders related to schizophrenia or psychosis 4. Personal history of any type of substance abuse or addiction 5. Pregnancy or breastfeeding 6. Feeding via percutaneous endoscopic gastrostomy (PEG) 7. Any other clinical condition that, in the investigator's judgment, could compromise the participant's safety or their ability to adhere to the study protocol. 8. Participation in other clinical trials within the past 30 days

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 1

1. ESAS-TSDS, defined as the total score derived from the sum of individual ratings for each of the nine symptoms included in the ESAS questionnaire.

Secondary endpoints 1

1. 1. NRS-2002 (Nutrition Risk Screening) score 2. Global Pittsburgh Sleep Quality Index (PSQI) score, reported as both the proportion of patients with sleep disturbances and the median total score 3. Douleur Neuropathique 4 (DN4) questionnaire score, reported as the proportion of patients with neuropathic pain and the median total score 4. Brief Fatigue Inventory (BFI) score 5. ESAS subscores at 8 weeks 6.Proportion of responders based on ESAS-TSDS at 8 weeks 7.Proportion of patients requiring

Investigational products

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

Test 1

Placebo 1

Sponsors and contacts

Sponsor organisations, regulatory contacts, third parties

IRCCS Istituto Nazionale Tumori Fondazione Pascale

Sponsor organisation

IRCCS Istituto Nazionale Tumori Fondazione Pascale

Address

Via Mariano Semmola 52

City

Naples

Postcode

80131

Country

Italy

Scientific contact point

Organisation

IRCCS Istituto Nazionale Tumori Fondazione Pascale

Contact name

Maria Carmela Piccirillo

Public contact point

Organisation

IRCCS Istituto Nazionale Tumori Fondazione Pascale

Contact name

Maria Carmela Piccirillo

Locations

1 EU/EEA country · 1 investigational sites

By country

Investigational sites

Results and documents

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

Documents 26 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