Ongoing Clinical Trials for Post Breast Therapy Pain Syndrome

Currently, there are 2 ongoing clinical trials investigating new treatment approaches for Post Breast Therapy Pain Syndrome (also known as Postmastectomy Syndrome, Chronic Neuropathic Pain of Post-Mastectomy Syndrome). These trials are testing different pain management techniques including botulinum toxin type A, capsaicin patches, and nerve block procedures in women who continue to experience chronic pain after breast cancer surgery.

Clinical trial locations

• France
  • Study Comparing Serratus Plane Block, Capsaicin, and Botulinum Toxin Type A for Chronic Pain in Post-Mastectomy Patients
• Spain
  • Study on Botulinum Toxin Type A and Capsaicin for Treating Postmastectomy Pain in Women After Breast Cancer Surgery

Study Comparing Serratus Plane Block, Capsaicin, and Botulinum Toxin Type A for Chronic Pain in Post-Mastectomy Patients

This clinical trial in France is evaluating three different treatment approaches for women experiencing chronic nerve pain after mastectomy surgery. The study compares a nerve block technique, a topical pain relief patch, and an injectable medication to determine which provides the most effective pain relief.

Main inclusion criteria:

• Women aged 18 years or older
• Previous surgery for breast cancer in one breast, including mastectomy with or without breast reconstruction
• Experiencing at least moderate chronic nerve pain that scores 3 or higher on a pain scale
• Pain occurring between 3 and 9 months after surgery
• Pain persisting despite trying first-line treatments for at least 4 weeks, such as medications like venlafaxine, gabapentin, or tricyclic antidepressants
• Pain located in a specific area at the surgical site, armpit, or inner arm on the same side as the surgery

Main exclusion criteria:

• Men are not eligible for this study
• Participants outside the specified age range cannot join
• Vulnerable populations requiring special protection or care are excluded

Study focus and goals:

The trial aims to find effective treatments for chronic nerve pain that continues after breast surgery. Participants are randomly assigned to receive one of three treatments: a Serratus Plane Block (a nerve block injection), an 8% capsaicin patch (applied to the skin), or Botulinum toxin type A (injected into the affected area). The main assessment occurs 8 weeks after treatment begins, where participants rate their pain on a scale from 0 to 10. Additional evaluations are conducted at regular intervals over 24 weeks to track changes in pain levels, quality of life, and any side effects. This research seeks to identify which treatment option offers the best pain management for women dealing with this challenging condition.

Investigational treatments being tested:

• Serratus Plane Block: A regional anesthesia technique involving injection of a local anesthetic near the serratus anterior muscle to block pain signals
• Capsaicin patch: An 8% capsaicin patch derived from chili peppers that works by desensitizing pain receptors in the skin
• Botulinum toxin type A: An injectable neurotoxin that blocks nerve signals causing muscle contractions, helping to alleviate pain

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

This clinical trial in Spain is comparing two treatment options for women experiencing moderate to severe pain after breast cancer surgery. The study tests whether botulinum toxin type A injections or capsaicin patches are more effective in managing this type of pain.

Main inclusion criteria:

• Women over 18 years old
• Previous surgery for a single breast tumor
• Experiencing moderate to severe pain related to postmastectomy syndrome
• Signed informed consent to participate in the study

Main exclusion criteria:

• Men cannot participate
• Patients who have not undergone surgery for a single breast tumor are excluded
• Patients without moderate to severe pain related to postmastectomy syndrome cannot join
• Patients outside the specified age range are not eligible
• Vulnerable populations are excluded from participation

Study focus and goals:

This trial investigates whether botulinum toxin type A injections or topical capsaicin patches provide better pain relief for women suffering from postmastectomy syndrome. Participants are randomly assigned to receive one of the two treatments, and neither the participants nor the researchers know which treatment is being given, ensuring unbiased results. Throughout the study, pain intensity is regularly measured using a visual scale, and researchers record the type of pain experienced, such as burning, stabbing, pressure, or numbness. Side effects, patient satisfaction levels, and any additional pain medications used are also monitored. The study is estimated to conclude by December 2025.

Investigational treatments being tested:

• Botulinum Toxin type A: An injectable medication that blocks nerve signals causing muscle contractions, helping to reduce pain and discomfort in the affected area
• Topical Capsaicin: A cream or ointment applied to the skin, containing an active ingredient from chili peppers that affects skin nerves to reduce pain sensations

Summary

Both ongoing clinical trials for Post Breast Therapy Pain Syndrome focus on finding effective pain management solutions for women who continue to experience chronic pain after breast cancer surgery. A notable observation is that both studies are testing botulinum toxin type A and capsaicin, suggesting these treatments are considered promising options by the research community. The French trial takes a broader approach by including a third treatment option—the Serratus Plane Block—while the Spanish study focuses on a direct comparison between the two medication approaches.

Geographically, these trials are being conducted in Western Europe, specifically in France and Spain, indicating regional research interest in this condition. Both studies specifically target women, as postmastectomy syndrome primarily affects female breast cancer survivors. The trials employ similar eligibility criteria, requiring participants to have moderate to severe chronic pain that has not responded adequately to initial treatments.

These research efforts represent important steps toward improving quality of life for women living with persistent pain after breast cancer treatment, a condition that can significantly impact daily functioning and well-being.