Advanced Malignant Solid Tumor
Conditions
Keywords
TUmor Related symptom burden, Oncology patients, balanced THC/CBD extract
Brief summary
CAPTURE is a prospective, interventional, randomized, phase 2, double-blind, placebo-controlled study assessing 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 oncological 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.
Detailed description
Secondary objectives are: to assess the impact of the therapeutic add-on of a balanced THC/CBD extract (Avextra 10/10 oral solution) compared to placebo, in terms of: nutritional status, sleep quality, neuropathic pain, functional interference, severity of clinical symptoms assessed by ESAS sub scores and ESAS-TSDS response rate at 8 weeks.
Interventions
DRUGCannabis Extract Oil
Cannabis extract 10:10 oil solution consisting of 10 mg/ml 9 Tetrahydrocannabinol (THC and 10 mg/ml Cannabidiol ( diluted in medium chain triglyceride oil
OTHERPlacebo
Mixture of fatty oils with components according to the oil monographs of the European Pharmacopoeia
Sponsors
National Cancer Institute, Naples
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Written informed consent 2. Individuals of any sex, gender, sexual orientation, and ethnicity aged 18 or over 3. No previous use of Cannabis in the last 6 months 4. Patients with advanced oncological neoplasia with a life expectancy of at least 6 months on active antineoplastic treatment and with a compromised quality of life defined by at least one of the following criteria: 1. presence of physical symptoms, such as moderate or severe pain, nausea, vomiting, loss of appetite 2. presence of psychological symptoms, such as anxiety, depression and insomnia 5. ECOG ≤ 3 6. ESAS-TSDS score ≥ 16 7. Patients on stable therapy with "Level II" or Level III" opioids according to the WHO analgesic scale and/or with adjuvants 8. Women of childbearing age (Women Of Child Bearing Potential, WOCBP) are eligible for the study only if: 1. Negative pregnancy test 2. Willingness to use effective contraception (concurrent use of two methods with a Pearl Index \< 1%) during treatment and for at least 3 months after the last dose of the investigational product. 9. Male participants with partners of childbearing potential must agree to use condoms (with spermicide, if available) in combination with an additional highly effective contraceptive method used by their partner, during treatment period and for at least 3 months after the last dose of the investigational product.
Exclusion criteria
* 1\. Inability to understand and complete the questionnaires required by the study 2. Known hypersensitivity/allergy to THC or CBD 3. Psychiatric illness related to schizophrenia/psychosis 4. Personal history of any type of addiction 5. Pregnancy / breastfeeding 6. PEG feeding 7. Any other medical condition that, in the opinion of the physician, would affect the participant's safety or ability to comply with the study protocol 8. Concurrent participation in other clinical studies started less than 30 days ago
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Multidimensional assessment of the state of health: Edmonton Symptom Assessment System questionnaire(ESAS) | The ESAS questionnaire will be completed at baseline (day0), at visit1 (day 14), at visit2 (day 28), visit3 (day 42) and visit4 (day52) up to 2 months | ESAS-TSDS (Total Symptom Distress Score) is defined as the total score derived from the sum of individual ratings for each of the nine symptoms included in the ESAS questionnaire |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| NRS -2002 Nutrition Score Risk Screening | The NRS will be assessed at baseline (day0), at visit1 (day 14), at visit2 (day 28), visit3 (day 42)up to 2 months | change from baseline (day0) to visit 4 (day 56) and longitudinal change from baseline to visit4, including values at visit1 (day 14), visit2 (day 28), visit3 (day 42) |
| Sleep qualit- PSQI questionnaire | The PSQI questionnaire will be completed at baseline, visit2 (day 28) and visit4 (day 56) up to 2 months | PSQI global score in terms of proportion of patients with sleep disturbance and median score |
| Neuropathic pain - DN4 questionnaire | The DN4 questionnaire will be completed at baseline (day0), at visit1 (day 14), at visit2 (day 28), visit3 (day 42) and visit4 (day52) up to 2 months | change from baseline to visit4 (day 56) and longitudinal change from baseline to visit4, including values at visit1 (day 14), visit2 (day 28), visit3 (day 42) |
| Cancer-related asthenia - BFI questionnnaire | The BFI questionnaire will be completed at baseline (day0), at visit1 (day 14), at visit2 (day 28), visit3 (day 42) and visit4 (day52) up to 2 months | change from baseline to visit4 (day 56) and longitudinal change from baseline to visit4, including values at visit1 (day 14), visit2 (day 28), visit3 (day 42) |
| Antineoplastic therapies | Antineoplastic drugs are documented at all visits up to 2 months. | Proportion of patients requiring dose reductions, treatment delays, and discontinuation of antineoplastic treatment for reasons other than disease progression |
| Concomitant medications | Concomitant medications are documented at all visits up to 2 months | Average dose of concomitant analgesic and adjuvant drugs |
| adverse events | Adverse events, their severity and relationship to the investigational medicinal product will be documented at all visits (according to the CTC-AE system) up to 2 months | Incidence of adverse events judged by the investigator to be related to the investigational medicinal product by intensity. |
| treatment compliance | Intake of the investigational drug will be documented at all visits by monitoring the patient's diary up to 2 months | Proportion of patients requiring discontinuation of study treatment due to toxicity and overall duration of study treatment |
Countries
Italy
Outcome results
None listed