Study on Cannabidiol for Joint Pain in Early Breast Cancer Patients on Hormone Therapy

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What is this study about?

This clinical trial is focused on studying the effects of a treatment for joint pain in patients with early-stage breast cancer. The patients involved in this study have hormone-receptor positive (HR+) breast cancer and are receiving a type of treatment known as adjuvant endocrine therapy, specifically using medications called aromatase inhibitors (AI). These medications can sometimes cause joint pain, which is the focus of this study. The treatment being tested is an oral solution containing cannabidiol (CBD), a compound derived from the cannabis plant. The study will compare the effects of CBD with a placebo to see if it can help reduce the joint pain associated with AI treatment.

The purpose of the study is to evaluate the effectiveness and safety of the CBD oral solution over a period of 12 weeks. Participants will be randomly assigned to receive either the CBD solution or a placebo, and neither the participants nor the researchers will know which treatment each participant is receiving. This is known as a double-blind study. The study will follow a 2×2 crossover design, meaning that participants will switch treatments halfway through the study. This allows researchers to compare the effects of both treatments within the same group of participants. The main goal is to see if there is a significant reduction in joint pain, as measured by a tool called the Brief Pain Inventory.

Throughout the study, participants will be monitored for any changes in their joint pain, as well as other factors such as stiffness and overall joint function. The study will also assess the impact of the treatment on participants’ quality of life, anxiety, and depression levels. Safety will be closely monitored, with attention to any side effects that may occur. The study aims to provide valuable information on whether CBD can be a helpful treatment for joint pain in patients undergoing AI therapy for early breast cancer.

1 joining the study

Upon joining the study, the patient will be randomly assigned to receive either the cannabidiol (CBD) oral solution or a placebo. This process is double-blind, meaning neither the patient nor the researchers know which treatment is being administered at any given time.

2 treatment phase 1

The patient will begin taking the assigned treatment, which consists of oral drops of either the CBD solution or placebo. The dosage and frequency will be determined by the study protocol and communicated to the patient at the start of this phase.

This phase will last for 12 weeks, during which the patient will continue their regular use of aromatase inhibitors (AIs) for breast cancer treatment.

3 evaluation and crossover

After the initial 12-week treatment period, the patient’s musculoskeletal symptoms will be evaluated using the Brief Pain Inventory Short Form (BPI-SF).

Following this evaluation, the patient will switch to the alternate treatment (from CBD to placebo or vice versa) for another 12 weeks.

4 treatment phase 2

During this second treatment phase, the patient will continue taking the new assigned treatment (CBD or placebo) as per the study protocol.

The patient will maintain their regular AI therapy throughout this period.

5 final evaluation

At the end of the second 12-week period, the patient’s symptoms will be reassessed using the same methods as before.

The study aims to determine the efficacy of CBD in reducing joint pain associated with AI therapy in breast cancer patients.

6 completion of study

Upon completion of the study, the patient will no longer receive the study treatments. Any further treatment or follow-up will be determined by the patient’s healthcare provider.

Who Can Join the Study?

The patient must understand, sign, and date a written consent form before any study procedures are done. They should be willing to attend study visits and follow the study procedures.
The patient must report an average joint pain score of 4 or higher out of 10 on a pain scale within 7 days before joining the study.
The patient must be willing and able to attend scheduled visits, follow treatment plans, and undergo laboratory tests and other study procedures.
Women who can become pregnant must have a negative pregnancy test within 7 days before joining the study.
Women who can become pregnant must agree to use highly effective birth control methods during the study and for 3 months after stopping the study treatment. Men are advised to use condoms during intercourse to prevent passing the drug through seminal fluid.
The patient must have adequate bone marrow and organ function, as shown by specific blood test results.
The patient must have normal heart function, as shown by an ECG test, with a specific heart rate and QTcF interval.
The patient must be part of a social security system or have similar benefits.
The patient must be 18 years or older at the time of joining the study.
The patient must have confirmed invasive breast cancer at stage I, II, or III.
The patient’s breast cancer must be positive for certain hormone receptors (ER and/or PgR).
The patient must have been taking a standard dose of one of the approved aromatase inhibitors (anastrozole, exemestane, or letrozole) for at least 21 days and not more than 36 months before joining the study.
If needed, the patient must have completed chemotherapy and/or radiotherapy according to guidelines before joining the study.
The patient must have a performance status score of 0 to 2, which indicates their ability to perform daily activities.

Who Cannot Join the Study?

Patients who are not experiencing joint pain related to their current treatment.
Patients who do not have stage I, II, or III hormone-receptor positive breast cancer.
Patients who are not currently receiving treatment with aromatase inhibitors, which are medications used to lower estrogen levels in the body.
Patients who do not report an average joint pain score of 4 or higher out of 10 on a pain scale.
Patients who are not within the specified age range for the study.
Patients who do not meet the gender requirements for the study.
Patients who are part of a vulnerable population that the study is not designed to include.

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name	City	Country	Status
Institut Gustave Roussy	Villejuif	France

Other Sites

Site Name	City	Country	Status
Gkzisqf Rexbkl	Chevilly-Larue	France

Trial status

Country	Status	Recruitment Start
France	Not yet recruiting	02.09.2024

Trial locations

Investigated drugs:

Cannabidiol

Cannabidiol (CBD) Oral Solution is being tested in this clinical trial to see if it can help reduce joint pain in patients with early breast cancer who are undergoing adjuvant endocrine therapy. The study aims to determine the effectiveness and safety of this solution over a 12-week period.

Investigated diseases:

Hormone-Receptor Positive Breast Cancer – This type of breast cancer is characterized by the presence of hormone receptors on the surface of cancer cells, which means the cancer cells may receive signals from hormones like estrogen or progesterone that could promote their growth. It is typically classified into stages I, II, and III, indicating the extent of cancer spread. In early stages, the cancer is usually confined to the breast or nearby lymph nodes. As it progresses, it may spread to more lymph nodes or other parts of the body. Patients often receive treatments such as surgery, radiation, and hormone therapy to manage the disease. Hormone therapy, like aromatase inhibitors, can lead to side effects such as musculoskeletal pain, which is a common concern for patients undergoing this treatment.

Trial ID:

2023-505380-36-01

Protocol code:

CSET 2021/3373

Trial Phase:

Therapeutic confirmatory (Phase III)

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Study on Cannabidiol for Joint Pain in Early Breast Cancer Patients on Hormone Therapy

What is this study about?

Who Can Join the Study?

Who Cannot Join the Study?