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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

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What is this trial about?

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

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.

The research process

The trial runs in 4 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Start of study treatment

    The use of tar-0520 gel begins. this is a gel containing brimonidine tartrate applied directly to the skin.

  2. Step 2

    Medication application

    The tar-0520 gel is used as a topical treatment, meaning it is applied to the surface of the skin. the amount used is 3.2 grams.

  3. Step 3

    Monitoring for side effects

    The occurrence of any adverse events, which are side effects or unexpected medical issues, is monitored. this includes serious adverse events, which are more severe health problems.

  4. Step 4

    Assessment of hand and foot syndrome

    The severity of hand and foot syndrome, also known as palmar-plantar erythrodysesthesia (a condition causing redness, swelling, or pain on the palms of the hands and soles of the feet), is evaluated by an oncologist (a doctor specializing in cancer treatment).

Who can join the trial?

5 criteria

  • 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 trial?

3 criteria

  • 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.
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Investigated drugs

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.

What is already known about the treatment

Brimonidine tartrate - This medication is applied directly to the skin in a gel form. It is currently used in medical practice to help reduce redness in the eyes, but it is being studied here to see if it can prevent skin irritation. It works by narrowing the small blood vessels near the surface of the skin, which helps to decrease swelling and redness. It is classified as an alpha-2 adrenergic agonist.

Investigated diseases

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 detailsLast updated 2 Oct 2026
Age18+ yearsPhasePhase IITrial ID2025-524008-32-00Estimated enrolment25 patientsSponsorTarian Pharma

sourced from the EU Clinical Trials Register and site verification

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On this site, “treatment” means an investigational medicine being studied in a clinical trial. Its safety and efficacy for the use being studied have not yet been confirmed, some participants may receive a placebo or a comparator medicine, and taking part does not guarantee any health benefit. The decision to take part is made by the doctor at the research site. This site is for information only and does not replace medical advice.

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