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Study on Botulinum Toxin Type A and Capsaicin for Treating Postmastectomy Pain in Women After Breast Cancer Surgery

Verified siteRegistered drugNo placebo
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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 treatment of Postmastectomy Syndrome, a condition that can cause moderate to severe pain in women who have undergone surgery for breast cancer. The study will compare two treatments: Botulinum Toxin type A, also known by its code name NT 201, and topical Capsaicin. Botulinum Toxin type A is a solution for injection, while Capsaicin is applied as a cutaneous patch on the skin.

The purpose of the study is to determine how effective these treatments are in managing pain associated with Postmastectomy Syndrome. Participants will be randomly assigned to receive either Botulinum Toxin type A or Capsaicin. The study will be conducted in a way that neither the participants nor the researchers know which treatment is being administered, ensuring unbiased results. The trial will involve regular assessments of pain intensity and the type of pain experienced, such as burning or stabbing sensations.

Throughout the study, any side effects will be recorded, along with the level of satisfaction participants feel with their treatment. The use of any additional pain relief medications will also be monitored. This trial aims to provide valuable insights into the management of pain for women suffering from Postmastectomy Syndrome following breast cancer surgery.

The research process

The trial runs in 5 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Joining the study

    Upon joining the study, eligibility is confirmed. Participants must be women over 18 years of age who have undergone surgery for unilateral breast cancer and experience moderate to severe pain associated with postmastectomy syndrome.

    Participants must provide a signed informed consent form to proceed.

  2. Step 2

    Initial assessment

    An initial assessment is conducted to record the intensity of pain using a visual analogue scale (VAS).

    The predominant pain perception is characterized, noting sensations such as burning, stabbing, pressure, or numbness.

  3. Step 3

    Treatment administration

    Participants are randomly assigned to receive either botulinum toxin type A or topical capsaicin.

    Botulinum toxin type A is administered as a solution for injection, given intramuscularly.

    Topical capsaicin is applied using a cutaneous patch for transdermal use.

  4. Step 4

    Ongoing monitoring

    Throughout the study, pain intensity is regularly recorded using the VAS.

    Side effects are monitored and recorded.

    The degree of patient satisfaction with the treatment is assessed.

    Any additional pain relief medications taken by participants are documented.

  5. Step 5

    Study conclusion

    The study is estimated to conclude by December 1, 2025.

    Final assessments are conducted to evaluate the effectiveness of the treatments in managing postmastectomy syndrome pain.

Who can join the trial?

4 criteria

  • Women over 18 years old who have had surgery for a single breast tumor.
  • Patients experiencing painful symptoms that are part of postmastectomy syndrome, which is pain after breast surgery.
  • Patients with pain that is considered moderate to severe.
  • Patients who have signed a form agreeing to participate in the study, known as an informed consent form.

Who cannot join the trial?

5 criteria

  • Patients who are not women cannot participate.
  • Patients who have not undergone surgery for a single breast tumor cannot participate.
  • Patients who do not have moderate to severe pain related to Postmastectomy Syndrome cannot participate. Postmastectomy Syndrome is a condition that can occur after breast surgery, causing pain and other symptoms.
  • Patients who are not within the specified age range cannot participate. The age range is typically defined by the study, but it is not specified here.
  • Patients who belong to a vulnerable population cannot participate. A vulnerable population includes groups who may have limited ability to give informed consent or are at higher risk of harm.
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Investigated drugs

  • Botulinum Toxin type A

    is a medication used in this study to help reduce pain. It works by blocking nerve signals that cause muscles to contract, which can help relieve pain and discomfort in the affected area. In this trial, it is being tested for its effectiveness in treating pain after breast surgery.

  • Topical Capsaicin

    is a cream or ointment applied to the skin. It contains an active ingredient derived from chili peppers, which can help reduce pain by affecting the nerves in the skin. In this study, it is being used to see if it can effectively manage pain in women who have undergone breast surgery.

What is already known about the treatment

  • Botulinum Toxin Type A

    This medication is administered through injection and is currently being studied for its effectiveness in treating postmastectomy syndrome, a condition that can cause significant pain after breast surgery. It is well-documented in medical literature for various uses, including muscle relaxation. The main therapeutic indication in this trial is to alleviate moderate to severe pain associated with postmastectomy syndrome. At the molecular level, Botulinum Toxin Type A works by blocking the release of a neurotransmitter called acetylcholine, which reduces muscle contractions and pain. It is classified as a neurotoxin.

  • Topical Capsaicin

    This medication is applied directly to the skin and is being evaluated for its potential to relieve pain in postmastectomy syndrome. Capsaicin is widely recognized in medical literature for its pain-relieving properties. The primary therapeutic indication in this study is to manage moderate to severe pain following breast surgery. Capsaicin works by affecting the sensory nerves, leading to a decrease in the sensation of pain over time. It is classified as a topical analgesic.

Investigated diseases

Postmastectomy Syndrome – This condition occurs in some individuals who have undergone surgery to remove one or both breasts, typically due to breast cancer. It is characterized by persistent pain in the chest wall, armpit, or arm on the side of the surgery. The pain can vary in intensity and may be described as burning, stabbing, or a sensation of pressure or numbness. The syndrome is thought to result from nerve damage during surgery, leading to chronic pain. It can significantly affect the quality of life, as the pain may be constant or occur intermittently. The condition is not classified as a rare disease.
Trial detailsLast updated 2 Oct 2026
Age18+ yearsPhasePhase IIITrial ID2024-513609-29-01Protocol codeSPM 2024Estimated enrolment30 patientsSponsorFundacion Para El Fomento De La Investigacion Sanitaria Y Biomedica De La Comunitat Valenciana

sourced from the EU Clinical Trials Register and site verification

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