Phase III, single-center, randomized, double-blind, placebo-controlled, 2x2 cross- over study, assessing the efficacy of CBD in patients with early HR+ BC, presenting aromatase inhibitor-related musculoskeletal pain
Patient must understand, sign and date the written informed consent form (ICF) prior to any protocol-specific procedures performed. Patient should be able and willing to comply with study visits and procedure as per protocol.
Patient must be affiliated to a social security system or beneficiary of the same.
Patient is ≥ 18 years-old at the time of study inclusion
Patient has histologically confirmed invasive Stage I, II, III breast cancer.
Patient with distant metastases of breast cancer beyond regional lymph nodes (M1 disease according to AJCC 8th edition).
Patient has not recovered from clinical and laboratory acute toxicities of chemotherapy, radiotherapy and/or surgery (i.e. patient has toxicities attributed to prior anti-neoplastic therapy NCI CTCAE version 5.0 grade ≥1 at day of randomization, excluding alopecia and amenorrhea)
Patient has a concurrent invasive malignancy or a prior invasive malignancy whose treatment was completed within 2 years before ICF signature. Note: Patients with prior or concurrent in situ malignancies are eligible provided that adequate curative treatment is completed prior to randomization
Patient has previous history of bone fracture or surgery of the affected knees, hands or both within 6 months prior to enrolment or known rheumatologic diseases;
Crossover
CBD oil
DrugPatients will receive CBD-oral solution 2.5 mg/kg PO BID for a total of 12 weeks.
Placebo
DrugPatients will receive placebo for a total of 12 weeks.
Brief Pain Inventory - Short Form (BPI-SF) Interference score.
The BPI is a 14-item questionnaire that asks patients to rate pain over the last 24 hours and the degree to which it interfered with activities on a 0-10 scale, where higher scores indicate more pain.
Western Ontario and McMaster Universities Osteoarthritis scale (WOMAC).
This is a 24-item questionnaire that is used to assess pain, stiffness, and functioning in the knees and hips during the past week. The test questions are scored on a scale of 0-4, which correspond to: None (0), Mild (1), Moderate (2), Severe (3), and Extreme (4). The scores for each subscale are summed up, with a possible score range of 0-20 for Pain, 0-8 for Stiffness, and 0-68 for Physical Function. Usually a sum of the scores for all three subscales gives a total WOMAC score, however there are other methods that have been used to combine scores.\[1\] Higher scores on the WOMAC indicate worse pain, stiffness, and functional limitations.
EORTC QLQ-C30
The EORTC Quality of Life Questionnaire-C30 (EORTC QLQ-C30) contains 30 questions and assesses the quality of life of oncological patients multidimensionally over 10 subscales. All sub-scales and the 6 individual items have a score range from 0 to 100 points. A higher score represents better function and a higher quality of life. In the symptom subscale, however, a higher score represents a higher level of symptoms or problems.
EORTC QLQ-BR45.
The QLQ-BR45 is a supplementary questionnaire module to be employed in conjunction with the QLQ-C30. The QLQ-BR45 incorporates nine multi-item scales to assess body image, sexual functioning, breast satisfaction, systemic therapy side effects, arm symptoms, breast symptoms, endocrine therapy symptoms, skin mucosis symptoms, endocrine sexual symptoms. In addition, single items assess sexual enjoyment, future perspective and being upset by hair loss. All of the scales and single item measures range in score from 0 to 100. A high score for the functional scales and functional single items represents a high/healthy level of functioning, whereas a high score for the symptom scales and symptom item represents a high level of symptomatology or problems.
EORTC QLQ-FA12.
The FA12 is the new fatigue module designed to complement the EORTC QLQ-C30. It consists of 12 items, with four response categories for each item, coded with values from 1 to 4. In accordance with the scales of the EORTC QLQ-C30, the FA12 scores are transformed to the range 0-100, with higher levels indicating greater degrees of fatigue.
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