Cannabis extrAct in Oncology Patients for the Treatment of TUmor Related Symptom Burden

Официальное название

Cannabis extrAct in Oncology Patients for the Treatment of TUmor Related Symptom Burden (CAPTURE)

Обзор

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.

Подробное описание

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.

Вмешательства

• Препарат Cannabis 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
• Другое Placebo
  Mixture of fatty oils with components according to the oil monographs of the European Pharmacopoeia

Первичные конечные точки

• Multidimensional assessment of the state of health: Edmonton Symptom Assessment System questionnaire(ESAS) [Срок оценки: 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]

Вторичные конечные точки (8)

• NRS -2002 Nutrition Score Risk Screening [Срок оценки: The NRS will be assessed at baseline (day0), at visit1 (day 14), at visit2 (day 28), visit3 (day 42)up to 2 months]
• Sleep qualit- PSQI questionnaire [Срок оценки: The PSQI questionnaire will be completed at baseline, visit2 (day 28) and visit4 (day 56) up to 2 months]
• Neuropathic pain - DN4 questionnaire [Срок оценки: 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]
• Cancer-related asthenia - BFI questionnnaire [Срок оценки: 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]
• Antineoplastic therapies [Срок оценки: Antineoplastic drugs are documented at all visits up to 2 months.]
• Concomitant medications [Срок оценки: Concomitant medications are documented at all visits up to 2 months]
• adverse events [Срок оценки: 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]
• treatment compliance [Срок оценки: Intake of the investigational drug will be documented at all visits by monitoring the patient's diary up to 2 months]

Критерии участия

Критерии включения

• Written informed consent
• Individuals of any sex, gender, sexual orientation, and ethnicity aged 18 or over
• No previous use of Cannabis in the last 6 months
• 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:

• presence of physical symptoms, such as moderate or severe pain, nausea, vomiting, loss of appetite
• presence of psychological symptoms, such as anxiety, depression and insomnia
• ECOG ≤ 3
• ESAS-TSDS score ≥ 16
• Patients on stable therapy with "Level II" or Level III" opioids according to the WHO analgesic scale and/or with adjuvants
• Women of childbearing age (Women Of Child Bearing Potential, WOCBP) are eligible for the study only if:

• Negative pregnancy test
• 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.
• 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.

Критерии исключения

• 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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Двойное слепое

Основная цель

Поддерживающая терапия

Центры проведения

Италия · 1 центр

• IRCCS Fondazione G. Pascale — Naples

Идентификаторы

NCT: NCT07459920 · CAPTURE · 2024-519568-42-00

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

Открыть это исследование на ClinicalTrials.gov ↗