Not yet recruitingPHASE3INTERVENTIONAL

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

This research study is investigating if a special type of CBD oil can reduce joint pain in women who have had early breast cancer. These women often experience joint pain as a side effect of their hormone therapy, which is known as aromatase inhibitor (AI) treatment. The study is a Phase 3 trial, meaning it's a key step to see if this CBD oil could become a new treatment option. Participants will receive either the CBD oil or a dummy treatment (placebo) to help researchers understand if CBD is truly making a difference. The aim is to find effective ways to manage AI-related pain, improving quality of life for these patients. It's a randomised, double-blind study, which means neither the patients nor the doctors will know who is getting the CBD oil and who is getting the placebo.

At a glance

Status

Not yet recruiting

Phase

PHASE3

Sponsor

Gustave Roussy, Cancer Campus, Grand Paris

Enrolment target

130

Start

01 Dec 2025

Estimated completion

01 May 2027

Breast Cancer Stage I Breast Cancer Stage II Breast Cancer Stage III HR+ Breast Cancer AI-related Musculoskeletal Pain

What is this study about?

This study is designed to explore a common and often challenging side effect for women who have been treated for breast cancer. Many women with early-stage breast cancer receive hormone therapy, often called aromatase inhibitors (AIs), to prevent the cancer from returning. While these treatments are very important, they can sometimes cause joint and muscle pain, making everyday life uncomfortable. This pain is known as AI-related musculoskeletal pain, and it can affect a patient's quality of life.

Researchers are looking into whether a specific oral CBD (cannabidiol) solution could help ease this joint pain. CBD is a chemical found in cannabis plants, but it doesn't cause the 'high' associated with recreational cannabis. The study is in its third phase, which means it has already shown some promise in earlier tests and is now being investigated in a larger group of people to confirm its effectiveness and safety.

The goal of this research is to find new and safe ways to manage this pain. By reducing discomfort, patients may find it easier to stick with their vital hormone therapy, improving their overall health and well-being. This study aims to provide clear answers about whether CBD could be a helpful option.

Key takeaways

This study investigates CBD oil for joint pain caused by hormone therapy in women with early breast cancer.
It's a Phase 3 trial, a crucial step to see if CBD could become a recognised treatment.
Participants will receive either CBD oil or a dummy treatment, with neither patient nor doctor knowing which.
The goal is to improve quality of life by reducing pain and helping patients stay on their vital breast cancer treatment.
You can leave the study at any time without affecting your medical care.
Close medical monitoring and support are provided throughout the study.

Who may be eligible?

This study is looking for women aged 18 or over who have been diagnosed with early-stage breast cancer (Stage I, II, or III).

To join, your breast cancer must be hormone receptor positive (meaning it's affected by hormones like oestrogen or progesterone) and you must be taking a specific type of hormone therapy called an aromatase inhibitor (like anastrozole, exemestane, or letrozole) for your breast cancer. You should have been on this treatment for at least three weeks but no longer than three years. You also need to be experiencing joint pain related to this hormone therapy, with your pain level being at least 4 out of 10 on a simple pain scale.

Before joining, you'll need to be able to understand and sign a consent form, agree to attend all study visits, and if you could become pregnant, you must be using effective contraception throughout the study and have a negative pregnancy test. Any past chemotherapy or radiotherapy should have been completed before you start this study.

Could this study suit you?

Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.

Are you 18 years old or older?
Have you been diagnosed with Stage I, II, or III hormone receptor-positive breast cancer?
Are you currently taking one of these hormone therapies: anastrozole, exemestane, or letrozole?
Have you been on this hormone therapy for at least 3 weeks but no more than 3 years?
Are you experiencing joint pain related to your hormone therapy, rated at least 4 out of 10?
If you could become pregnant, are you willing to use effective contraception during the study?

Answer every question to see your result.

What does participation involve?

If you decide to take part, you'll be given either the CBD oil or a dummy treatment (placebo) to take. Neither you nor your study doctor will know which one you're receiving. You'll need to attend regular clinic visits where the study team will monitor your pain levels, check for any side effects, and generally keep an eye on your health. You'll also have blood tests and other assessments throughout the study to track your progress.

The study involves a 'cross-over' design. This means that after a certain period, you might switch from the CBD oil to the placebo, or vice versa, without knowing it, allowing researchers to compare the effects more accurately. You'll need to follow a specific treatment plan and attend all scheduled appointments. The total duration of your involvement in the study will be explained to you by the study team.

Potential risks and benefits

Potential benefits of joining this study include the possibility that the CBD oil could ease your joint pain, improving your comfort and quality of life. Even if you receive the placebo, you'll be closely monitored by a medical team. However, there are potential risks, as with any medication. CBD can have side effects, which will be fully explained to you. You might also experience side effects from the placebo, or the study might not improve your pain. It's important to remember that you are free to withdraw from the study at any time, for any reason, without it affecting your usual medical care.

Locations (1)

Gustave Roussy
Verified postcode
Villejuif, France

Common questions

What is CBD oil?

CBD oil is a product that contains cannabidiol, a substance from the cannabis plant. It's different from cannabis that makes you feel 'high' because it doesn't contain the psychoactive component (THC) in significant amounts.

Why are aromatase inhibitors used?

Aromatase inhibitors are a type of hormone treatment given to women with certain types of breast cancer to help prevent the cancer from coming back.

What does 'randomised' and 'double-blind' mean?

Randomised means you'll be assigned to either the CBD group or the placebo group by chance. Double-blind means neither you nor your doctors will know which treatment you are receiving, to keep the results unbiased.

Will I still get my usual cancer treatment?

Yes, this study is about managing a side effect of your existing breast cancer treatment. You will continue to receive your standard care.

What if the CBD oil doesn't help my pain?

Your pain will be regularly monitored during the study. If your pain isn't getting better, the study team will discuss other pain management options with you.

How to find out more

Barbara PISTILLI, MD

barbara.pistilli@gustaveroussy.fr +33 1 42 11 42 93 Official trial record

Always speak to your GP or specialist before deciding to take part in a study.