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

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What is this trial about?

A plain-language summary of the goals, design and what participants do

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 breast cancer that is hormone-receptor positive, meaning their cancer cells grow in response to hormones. These patients are receiving a type of treatment called adjuvant endocrine therapy, specifically using medications known as aromatase inhibitors. These inhibitors can sometimes cause joint pain, which is the focus of this study.

The treatment being tested is an oral solution containing cannabidiol, also known as CBD. CBD is a compound derived from the cannabis plant, and it is being studied for its potential to relieve joint pain associated with aromatase inhibitors. The study will compare the effects of CBD with a placebo over a period of 12 weeks to see if it can help reduce the pain experienced by patients. The goal is to determine if CBD can effectively alleviate the musculoskeletal symptoms that some patients experience during their cancer treatment.

Participants in the study will receive either the CBD oral solution or a placebo in a randomized and double-blind manner, meaning neither the participants nor the researchers will know who is receiving the actual treatment or the placebo. This approach helps ensure the results are unbiased. The study will monitor the participants' joint pain and overall well-being throughout the trial period, using various assessments to gather data on the treatment's safety and effectiveness. The study aims to provide valuable insights into whether CBD can be a beneficial addition to the treatment plan for patients experiencing joint pain due to their cancer therapy.

The research process

The trial runs in 6 steps – from screening to follow-up. Each step says what happens and what the team monitors.

Step 1
Initial visit
Upon joining the study, you will attend an initial visit. During this visit, you will be asked to provide informed consent, which means you agree to participate after understanding the study details.
You will undergo a series of assessments to confirm eligibility, including a review of your medical history and current health status. A pregnancy test will be conducted if applicable.
Step 2
Randomization
After eligibility is confirmed, you will be randomly assigned to one of two groups. One group will receive the cannabidiol (CBD) oral solution, and the other will receive a placebo. This process is double-blind, meaning neither you nor the study team will know which group you are in.
Step 3
Treatment phase 1
You will begin taking the assigned oral drops. The dosage and frequency will be provided by the study team. This phase lasts for 12 weeks.
You will be required to attend scheduled visits for monitoring and to complete questionnaires about your joint pain and overall health.
Step 4
Washout period
After the first treatment phase, there will be a washout period. This is a break in treatment to ensure that the effects of the first phase do not influence the next phase. The duration of this period will be communicated to you by the study team.
Step 5
Treatment phase 2
You will switch to the other treatment (CBD or placebo) for another 12 weeks. This is part of the crossover design of the study.
Similar to the first phase, you will continue to attend scheduled visits and complete questionnaires.
Step 6
Final assessment
At the end of the second treatment phase, you will undergo a final assessment. This will include a review of your health status and any changes in your joint pain.
You will also be asked to provide feedback on your experience during the study.

Who can join the trial?

11 criteria

The patient must understand, sign, and date a written consent form before any study procedures are done. This means they agree to participate in the study.
The patient must be at least 18 years old.
The patient must have been diagnosed with stage I, II, or III breast cancer that is hormone-receptor positive (HR+). This means the cancer cells grow in response to hormones like estrogen or progesterone.
The patient must be taking one of the three approved aromatase inhibitors (AIs) for at least 21 days but not more than 36 months before joining the study. AIs are medications that lower estrogen levels in the body.
The patient must have completed any necessary chemotherapy or radiotherapy treatments before joining the study, if recommended by their doctor.
The patient must have an Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2. This is a scale used to assess how a patient's disease is progressing and how the disease affects their daily living abilities.
The patient must report an average joint pain score of 4 or higher out of 10 on a pain scale called the Brief Pain Inventory 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 and must agree to use highly effective birth control methods during the study and for 3 months after stopping treatment. Men are also advised to use condoms during this period.
The patient must have adequate bone marrow and organ function, as shown by specific blood test results.
The patient must have a normal 12-lead ECG test, which measures the heart's electrical activity, with specific values for heart rate and other measurements.

Who cannot join the trial?

7 criteria

Patients who do not have stage I, II, or III hormone-receptor positive (**HR+**) breast cancer.
Patients who are not receiving adjuvant aromatase inhibitors (**AI**), which are medications used to lower estrogen levels in the body.
Patients who do not experience **AI-related musculoskeletal pain**, which is pain in the muscles and joints caused by the medication.
Patients whose average joint pain score is less than 4 out of 10 on the Brief Pain Inventory, a tool used to measure pain levels.
Patients who are not within the specified age range for the study.
Patients who do not identify as female or male, as the study includes both genders.
Patients who are part of a vulnerable population, which may include groups like children, pregnant women, or those unable to give consent.

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Institut Gustave Roussy
Verified
Villejuif, France

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Investigated drugs

Cannabidiol is a substance that comes from the cannabis plant. In this study, it is used in the form of an oral solution. The purpose of using cannabidiol is to see if it can help reduce joint pain that some patients experience when they are undergoing hormone therapy for early breast cancer. The study aims to find out if taking cannabidiol for 12 weeks can make a difference in the level of pain patients feel, compared to not taking it.

Cannabidiol

What is already known about the treatment

Cannabidiol oral solution – This medication is taken by mouth in the form of a liquid solution. It is currently being studied in clinical trials to assess its effectiveness and safety for reducing joint pain in patients with early-stage hormone-receptor positive breast cancer who are experiencing pain due to aromatase inhibitor therapy. The main therapeutic use being investigated is the relief of musculoskeletal pain associated with cancer treatment. At the molecular level, cannabidiol is thought to interact with the body's endocannabinoid system, which plays a role in regulating pain and inflammation. It is classified pharmacologically as a cannabinoid, a type of compound found in cannabis plants.

Investigated diseases

Hormone-Receptor Positive Breast Cancer – This type of breast cancer is characterized by the presence of receptors for hormones like estrogen or progesterone on the surface of the cancer cells. These receptors allow the cancer cells to grow in response to these hormones. The disease progresses through stages I to III, where stage I is early and localized, while stage III indicates more extensive spread to nearby tissues or lymph nodes. Patients often receive adjuvant therapy, such as aromatase inhibitors, to reduce hormone levels and slow cancer growth. A common side effect of this treatment is musculoskeletal pain, particularly joint pain. This pain can significantly impact daily activities and quality of life.