Trials / Not Yet Recruiting
Not Yet RecruitingNCT06787118
Study Assessing the Efficacy and Safety of cANnabidiol Oral Solution for Joint Pain of Adjuvant enDOcrine theRApy in Patients With Early Breast Cancer
Randomized, Double-blind, Placebo-controlled, 2x2 Cross Over Study Assessing the Efficacy and Safety of cANnabidiol Oral Solution for Joint Pain of Adjuvant enDOcrine theRApy in Patients With Early Breast Cancer
- Status
- Not Yet Recruiting
- Phase
- Phase 3
- Study type
- Interventional
- Enrollment
- 130 (estimated)
- Sponsor
- Gustave Roussy, Cancer Campus, Grand Paris · Academic / Other
- Sex
- Female
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
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
Conditions
- Breast Cancer Stage I
- Breast Cancer Stage II
- Breast Cancer Stage III
- HR+ Breast Cancer
- AI-related Musculoskeletal Pain
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | CBD oil | Patients will receive CBD-oral solution 2.5 mg/kg PO BID for a total of 12 weeks. |
| DRUG | Placebo | Patients will receive placebo for a total of 12 weeks. |
Timeline
- Start date
- 2025-12-01
- Primary completion
- 2027-05-01
- Completion
- 2027-05-01
- First posted
- 2025-01-22
- Last updated
- 2025-12-02
Locations
1 site across 1 country: France
Source: ClinicalTrials.gov record NCT06787118. Inclusion in this directory is not an endorsement.