A study to evaluate the safety of brimonidine tartrate gel in preventing hand and foot syndrome in patients with colorectal or breast cancer treated with capecitabine

2 1 1

What is this study about?

This study investigates the use of TAR-0520 gel to prevent Hand and Foot Syndrome. This condition, also known as palmar-plantar erythrodysesthesia, is a side effect that can occur in people receiving certain types of chemotherapy, such as capecitabine, used to treat colorectal cancer or breast cancer. The condition typically involves redness, swelling, pain, or numbness on the palms of the hands and the soles of the feet.

The main goal of this research is to evaluate the safety of applying TAR-0520 gel, which contains the active substance brimonidine tartrate, to the skin. During the study, participants will use this topical gel, which is applied directly to the skin, to see if it can help prevent the skin reactions associated with their cancer treatment.

Who Can Join the Study?

You must be a man or a woman who is at least 18 years old at the time of your first screening visit.
You must have been diagnosed with breast cancer or colorectal cancer (cancer of the colon or rectum).
Your treatment plan must include capecitabine, which is a type of chemotherapy (medicine used to kill cancer cells), used as a monotherapy (meaning it is the only drug being used for treatment).
The cancer treatment can be in an adjuvant or neoadjuvant setting (treatment given after surgery to prevent cancer from returning, or before surgery to shrink a tumor) or a palliative setting (treatment intended to relieve symptoms and improve quality of life rather than cure the disease).
You must be starting capecitabine at a specific dose of at least 1000 mg per square meter of body surface area, taken twice daily every 2 out of every 3 weeks.

Who Cannot Join the Study?

You cannot participate if you have previously taken capecitabine, which is a type of chemotherapy medication used to treat cancer.
You are excluded if you already have neuropathy of grade 2 or higher, which is a type of nerve damage that causes symptoms like numbness, tingling, or pain in the hands or feet. This condition must not interfere with the ability to judge hand and foot syndrome, which is a skin reaction (redness, swelling, or pain) that can happen during certain cancer treatments.
You cannot join the study if you have Raynaud’s syndrome, a condition where blood vessels in the fingers or toes narrow excessively in response to cold or stress, or if you have other vascular peripheral disorders, which are problems with the blood vessels located in your arms or legs.

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

No sites found in this category

Other Sites

Site Name	City	Country	Status
Izzvrkoi Plvoxhttnpkmdtc Cztoip Cljegi	Marseille	France

Trial status

Country	Status	Recruitment Start
France	Not yet recruiting	16.03.2026

Trial locations

Investigated drugs:

Brimonidine Tartrate

Brimonidine tartrate gel is a topical medicine applied to the skin. In this study, it is being tested to see if it can help prevent hand and foot syndrome in patients undergoing cancer treatment.

Capecitabine-induced hand and foot syndrome – This condition occurs as a reaction to the use of certain cancer medications. It primarily affects the palms of the hands and the soles of the feet. The skin in these areas may become red, swollen, or painful. Some individuals might also experience peeling or blistering of the skin. The symptoms typically develop gradually during the course of the medication regimen.

Trial ID:

2025-524008-32-00

Trial Phase:

Therapeutic exploratory (Phase II)

Other Trials to Consider

#1 Clinical Trials Search in Europe

A study to evaluate the safety of brimonidine tartrate gel in preventing hand and foot syndrome in patients with colorectal or breast cancer treated with capecitabine

What is this study about?

Who Can Join the Study?

Who Cannot Join the Study?