II, III hormone-receptor positive (HR+) breast cancer (BC) receiving adjuvant aromatase inhibitors (AI) and presenting AI-related musculoskeletal pain (reported average joint pain score of ≥ 4 out of 10 on the Brief Pain Inventory), Patients with stage I
Conditions
Brief summary
The primary endpoint is efficacy of CBD on AI-associated pain, measured by the BPI-SF. A one-point difference in BPI average joint pain is considered a minimal important difference and clinically meaningful
Detailed description
Articular function, stiffness and pain of knees and hips as measured by the Western Ontario and McMaster Universities Osteoarthritis scale (WOMAC) Qol Qol domains will be assessed using: EORTC QLQ-C30 EORTC QLQ-BR45 (Aaronson et al. 1993; Bjelic-Radisic et al. 2020), and the fatigue subscale EORTC QLQ-FA12, Anxiety and depression. Anxiety and depression will be assessed using the Hospital Anxiety and Depression Scale (HADS), Adherence : patient’s self-reporting through the questionnaire MIS (medication intake survey), collected at baseline and weeks 4, 12, 13, 17, 25 and 37, Safety. A trained research nurse will collect side effects measured by CTCAE V.5. An adverse event (AE) is defined as any untoward medical occurrence, in a patient or clinical trial subject treated by a medicinal product and which does not necessarily have a causal relationship with this treatment. The AE collected will be particularly focused on nausea, constipation, cognitive dysfunction, nervous system and psychiatric side effects. Drug consumption and Hospitalizations associated with nervous system and psychiatric disorders, Risk-taking behavior. Information on risk perception and attitude in risk-taking situations will be evaluated with the DOSPERT (Domain-Specific Risk-Taking) scale., Daily pain medication consumption for muskuloskeletal symptoms collected through a daily diary filled in by each participant, Drug addiction will be assessed using the CAST questionnaire
Interventions
Sponsors
Institut Gustave Roussy
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary endpoint is efficacy of CBD on AI-associated pain, measured by the BPI-SF. A one-point difference in BPI average joint pain is considered a minimal important difference and clinically meaningful | — |
Secondary
| Measure | Time frame |
|---|---|
| Articular function, stiffness and pain of knees and hips as measured by the Western Ontario and McMaster Universities Osteoarthritis scale (WOMAC) Qol Qol domains will be assessed using: EORTC QLQ-C30 EORTC QLQ-BR45 (Aaronson et al. 1993; Bjelic-Radisic et al. 2020), and the fatigue subscale EORTC QLQ-FA12, Anxiety and depression. Anxiety and depression will be assessed using the Hospital Anxiety and Depression Scale (HADS), Adherence : patient’s self-reporting through the questionnaire MIS (medication intake survey), collected at baseline and weeks 4, 12, 13, 17, 25 and 37, Safety. A trained research nurse will collect side effects measured by CTCAE V.5. An adverse event (AE) is defined as any untoward medical occurrence, in a patient or clinical trial subject treated by a medicinal product and which does not necessarily have a causal relationship with this treatment. The AE collected will be particularly focused on nausea, constipation, cognitive dysfunction, nervous system and psy | — |
Countries
France
Outcome results
None listed