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Study Assessing the Efficacy and Safety of cANnabidiol Oral Solution for Joint Pain of Adjuvant enDOcrine theRApy in Patients With Early Breast Cancer

NCT06787118 · Status: NOT_YET_RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 130

Last updated 2025-12-02

No results posted yet for this study

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

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.

Sponsors & Collaborators

  • Gustave Roussy, Cancer Campus, Grand Paris

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
DOUBLE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-12-31
Primary Completion
2027-05-31
Completion
2027-05-31

Countries

  • France

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06787118 on ClinicalTrials.gov