BridgeMD
Cannabis extrAct in oncology Patients for the treatment of TUmor Related symptom burden (CAPTURE)
EU CTIS ID: 2024-519568-42-00
What this study is testing
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.
- Therapeutic exploratory (Phase II)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- 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%)
You likely can't join if
- 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
The study team makes the final eligibility decision.
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 65+ years, 18-64 years. The study team makes the final eligibility decision.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.