AuthorisedTherapeutic confirmatory (Phase III)Interventional

Randomized, double-blind, Placebo-controlled, 2x2 cross over study assessing the efficacy and safety of cANnabidiol oral solution for joint pain of adjuvant enDOcrine theRApy in patients with early breast cancer (PANDORA)

The PANDORA study is investigating if a specific CBD oral solution, called LGP PURE CBD 200, can relieve joint pain in women with early breast cancer. These women are currently undergoing hormone therapy with aromatase inhibitors, which can sometimes cause painful joints. Researchers will compare the CBD solution to a liquid without any active medicine (a placebo) to see if the CBD is effective and safe. The study will also look at how CBD affects stiffness, physical function, and how participants feel overall, including their quality of life, mood, and any potential side effects. This research is a 'Phase III' study, which means it's a key step to confirm if the treatment works.

At a glance

Status

Authorised

Phase

Therapeutic confirmatory (Phase III)

Sponsor

Institut Gustave Roussy

Enrolment target

130

Start

09 Sep 2024

Patients with stage I

What is this study about?

Many women with early breast cancer take hormone therapy, called aromatase inhibitors, to help prevent the cancer from returning. While these medicines are very effective, a common side effect for some women is joint pain. This pain can sometimes be quite severe and can impact daily life.

This study, called PANDORA, is trying to find out if a specific oral CBD solution (LGP PURE CBD 200) can help ease this joint pain. Researchers want to see if CBD can make a meaningful difference to how much pain women experience, compared to taking a liquid that looks and tastes the same but doesn't contain any active medicine (a placebo). The study is designed very carefully so that neither the participants nor their doctors will know who is getting the CBD and who is getting the placebo, to ensure the results are as unbiased as possible.

Beyond just pain, the study will also look at other important aspects of a patient's health. This includes how well their joints can move, how stiff they feel, their general quality of life, and if there are any changes in their mood, like anxiety or feeling down. They will also keep a close eye on any side effects that might occur. The information gathered from this study could help future patients find better ways to manage their joint pain while undergoing crucial breast cancer treatment.

Key takeaways

Investigating CBD for joint pain caused by breast cancer hormone therapy.
Compares CBD solution to a dummy treatment (placebo).
Looks at pain levels, joint movement, quality of life, and mood.
Participants switch between CBD and placebo at different times.
Close monitoring for side effects and overall well-being.
Findings could help manage joint pain for breast cancer patients.

Who may be eligible?

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

Crucially, your breast cancer must be hormone-receptor positive, meaning your cancer cells grow in response to hormones, and you must be receiving a type of hormone therapy called an aromatase inhibitor.

To be eligible, you also need to be experiencing joint pain related to your aromatase inhibitor treatment. Specifically, your average joint pain score should be at least 4 out of 10.

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 aromatase inhibitors for your breast cancer?
Do you experience joint pain from your aromatase inhibitors, with an average pain score of at least 4 out of 10?

Answer every question to see your result.

What does participation involve?

If you join this study, you will take either the CBD oral solution or a placebo (a liquid without active medicine) for a period. You will switch between these two treatments at different times during the study, so everyone gets a chance to try both, without knowing which one they are taking at any given time. This 'cross-over' design helps researchers compare the effects accurately.

You will have several visits to the study clinic throughout the year. At these visits, you'll be asked to fill out questionnaires about your pain, joint movement (stiffness and function), quality of life, mood, and any medications you are taking. A nurse will also check for any side effects. You'll need to keep a daily diary to record your pain levels and any pain relievers you use. The study will also monitor how consistently you take the study medicine. The total duration of participation in the study is 37 weeks.

Potential risks and benefits

Taking part in this study could potentially offer a benefit by helping to reduce your joint pain from hormone therapy, if the CBD solution proves effective. However, there's also a chance you might receive the placebo and not experience any pain relief from the study medication. As with any medication, there's always a risk of side effects, which the research team will monitor closely. You are free to withdraw from the study at any time, for any reason, without it affecting your usual medical care.

Locations (1)

Some site locations are approximate. We're improving this — please verify with the trial team before travelling.

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Unverified
France

Common questions

What is CBD?

CBD, or cannabidiol, is a compound found in the cannabis plant. It's different from THC, which is the part of cannabis that causes a 'high'. This study uses a specific CBD oral solution.

What is a 'placebo'?

A placebo is a 'dummy' treatment that looks, tastes, and is given in the same way as the active medicine, but it doesn't contain any active ingredients. It helps researchers see if any changes are truly due to the medicine or just the expectation of feeling better.

Why don't I know if I'm getting CBD or the placebo?

This is called a 'double-blind' study. It means neither you nor your study doctor will know who is getting the CBD and who is getting the placebo. This helps ensure the results are unbiased and accurate.

What are 'aromatase inhibitors'?

Aromatase inhibitors are a type of hormone therapy used to treat hormone-receptor-positive breast cancer. They work by lowering the amount of oestrogen in the body.

Will I have to stop my current breast cancer treatment?

No, this study is designed for patients who are already receiving aromatase inhibitors for early breast cancer. You will continue your prescribed breast cancer treatment as usual.