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

NCT06787118 | Not Yet Recruiting Phase 3

• 2 other identifiers: 2023-505380-36-012021/3373
• Study Type: interventional
• Target: 130
• Locations: 1 country
• Sites: 1

Brief 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

Outcome Measures

Primary Outcomes (1)

• 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.

  Baseline, 4 weeks, 12 weeks, 13 weeks, 17 weeks, 25 weeks, 37 weeks after starting treatment.

Secondary Outcomes (10)

• Western Ontario and McMaster Universities Osteoarthritis scale (WOMAC).

  Baseline, 4 weeks, 12 weeks, 13 weeks, 17 weeks, 25 weeks, 37 weeks after starting treatment.

• EORTC QLQ-C30

  Baseline, 4 weeks, 12 weeks, 13 weeks, 17 weeks, 25 weeks, 37 weeks after starting treatment.

• EORTC QLQ-BR45.

  Baseline, 4 weeks, 12 weeks, 13 weeks, 17 weeks, 25 weeks, 37 weeks after starting treatment.

• EORTC QLQ-FA12.

  Baseline, 4 weeks, 12 weeks, 13 weeks, 17 weeks, 25 weeks, 37 weeks after starting treatment.

• Hospital Anxiety and Depression Scale (HADS).

  Baseline, 4 weeks, 12 weeks, 13 weeks, 17 weeks, 25 weeks, 37 weeks after starting treatment.

Study Arms (2)

Arm 1 (CBD then Placebo)

EXPERIMENTAL

12 weeks CBD-oral solution 2.5 mg/kg x 2/day followed by 12 weeks placebo. A 1-week off-therapy period (wash out) +/-2 days will be performed between study periods.

Drug: CBD oil; Drug: Placebo

Arm 2 (Placebo then CBD)

EXPERIMENTAL

12 weeks Placebo followed by 12 weeks CBD-oral solution 2.5 mg/kg x 2/day (5 mg/kg/day). A 1-week off-therapy period (wash out) +/-2 days will be performed between study periods.

Drug: CBD oil; Drug: Placebo

Interventions

CBD oil DRUG

Patients will receive CBD-oral solution 2.5 mg/kg PO BID for a total of 12 weeks.

Arm 1 (CBD then Placebo); Arm 2 (Placebo then CBD)

Placebo DRUG

Patients will receive placebo for a total of 12 weeks.

Arm 1 (CBD then Placebo); Arm 2 (Placebo then CBD)

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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 has histologically confirmed invasive Stage I, II, III breast cancer.
• Patient has breast cancer that is positive for ER and/or PgR (nuclear staining of any intensity ≥ 10%)
• Patients should be taking a standard dose of one of the three approved AIs (i.e., anastrozole, exemestane, or letrozole) for at least 21 days, and not more than 36 months before trial registration; premenopausal patients are eligible if they are receiving AIs and ovarian function suppression (LHRH agonist).
• If indicated, patient has completed adjuvant and/or neoadjuvant chemotherapy according to the institutional guidelines, prior to randomization.
• If indicated, patient has completed adjuvant radiotherapy according to the institutional guidelines, prior to randomization.
• Patient has an Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2.
• Patients should report an Interference pain score of ≥ 4 out of 10 on the Brief Pain Inventory (BPI, Appendix 2) within 7 days before registration.
• Patient must be willing and able to comply with scheduled visits, treatment plans, laboratory tests, and other trial procedures.
• Women of childbearing potential (CBP), defined as all women physiologically capable of becoming pregnant, must have confirmed negative urine or serum pregnancy test (for β- hCG) within 14 days of randomization.
• Women of CBP, defined as all women physiologically capable of becoming pregnant, must be willing to use highly effective methods of contraception. It is recommended that sexually active males use a condom during intercourse and it is strongly advised that they do not father a child in this period (a condom is required to be used also by vasectomized men as well as during intercourse with a male partner in order to prevent delivery of the drug via seminal fluid). In all patients, contraception must continue during the trial treatment and for 3 months after stopping it, due to AI treatment. For women, highly effective contraception methods include:
• Total abstinence (when this is in line with the preferred and usual lifestyle of the patient). Periodic abstinence (e.g. calendar, ovulation, symptothermal, post-ovulation methods) and withdrawal are not acceptable methods of contraception;
• Female sterilization (have had surgical bilateral oophorectomy with or without hysterectomy), total hysterectomy or tubal ligation at least 6 weeks before taking trial treatment. In case of bilateral oophorectomy alone, only when the reproductive status of the woman has been confirmed by follow-up hormone level assessment;
• Placement of an intrauterine device (IUD). Notes:

You may not qualify if:

• 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;
• Patient has received opioids analgesics, systemic NSAIDs, topical analgesics, oral, intra-articular or intramuscular corticosteroids for treatment of joint pain or joint stiffness within 28 days prior registration;
• Patient has active hepatitis B virus (HBV) or hepatitis C virus (HCV) infection.
• Patients with moderate (Child-Pugh B) hepatic impairment or severe (Child-Pugh C) hepatic impairment.
• Patient has impairment of gastrointestinal (GI) function or GI disease that may significantly alter the absorption of the oral trial treatments (e.g. uncontrolled ulcerative diseases, uncontrolled nausea, vomiting or diarrhea, malabsorption syndrome, or small bowel resection).
• Patient has any other concurrent severe and/or uncontrolled medical condition that would, in the Investigators judgment, cause unacceptable safety risks, contraindicate patient participation in the clinical trial or compromise compliance with the protocol (e.g. chronic pancreatitis, chronic active hepatitis, liver cirrhosis or any other significant liver disease, active untreated or uncontrolled fungal, bacterial or viral infections, active infection requiring systemic anti-bacterial therapy, etc.) or limit life expectancy to ≤5 years.
• Participation in a prior interventional study and received trial treatment with an investigational product (or used an investigational device) within 30 days prior to randomization or within 5 half-lives of the investigational product, whichever is longer.
• Pregnant or breast-feeding (lactating) women or women who plan to become pregnant or breastfeed during the trial.
• Patient under guardianship or deprived of his liberty by a judicial or administrative decision or under justice protection or under curatorship or unable of giving his consent
• Patient with a known hypersensitivity to CBD or any of the excipients of CBD
• Previous serious adverse reaction to any cannabinoid product such as cannabinoid related psychosis, panic attack or delirium.
• Recreational or medicinal cannabis or synthetic cannabinoid based medications (including Sativex®) within 2 weeks before study entry

Sponsors & Collaborators

• Gustave Roussy, Cancer Campus, Grand Paris: lead

Study Sites (1)

Gustave Roussy

Villejuif, 94805, France

Location

Related Links

• In 2018, Little Green Pharma pioneered the Australian medical cannabis market and were able to launch Australia's first locally grown cannabis medicine.

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Central Study Contacts

Barbara PISTILLI, MD

CONTACT

+33 1 42 11 42 93; barbara.pistilli@gustaveroussy.fr

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 16, 2025
• First Posted: January 22, 2025
• Study Start: December 1, 2025
• Primary Completion (Estimated): May 1, 2027
• Study Completion (Estimated): May 1, 2027
• Last Updated: December 2, 2025

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)