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Compares treatment options for Post-Mastectomy Neuropathic Pain Syndrome
Official title Serratus Plane Block (SPB) Versus Capsaïcine Versus Botox-A for Chronic Neuropathic Pain in Post-mastectomy Syndrome
ClinicalTrials.gov ID: NCT06807164
What this study is testing
What is Capsaicin 8% Patch?
Capsaicin 8% Patch is an investigational medicine, given as a pill taken by mouth, being studied as a potential treatment for post-mastectomy neuropathic pain syndrome.
Also referred to as Qutenza®.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- The goal of this phase II clinical trial is to study the effectiveness of a treatment with Serratus Plane Block (SPB) or Botox-A in comparison with capsaicin for the control of chronic neuropathic pain of post-mastectomy syndrom, that is not adequately managed by systemic treatment alone. The primary outcome will be the pain evaluation at 8 weeks.
- Phase 2: a mid-size study of how well it works
- Time commitment: about 24 months
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older, women only
You may be able to join if
- Women aged ≥ 18 years;
- Unilateral breast cancer treated by total or partial mastectomy:
- with sentinel lymph node technique (SLN) or axillary dissection;
- with or without immediate reconstruction using a prosthesis;
- associated or not with radiotherapy and/or chemotherapy;
You likely can't join if
- Ipsilateral breast cancer recurrence, regardless of the first treatment;
- History of breast or thoracic surgery prior to mastectomy with residual pain;
- Painful polyneuropathy related to chemotherapy requiring treatment;
- Ongoing or planned loco-regional adjuvant radiotherapy within the next 8 weeks;
- Treatment area not suitable for potential botulinum toxin type A treatment;
- Breast reconstruction using flap or lipomodelling;
See the full eligibility criteria
- Women aged ≥ 18 years;
- Unilateral breast cancer treated by total or partial mastectomy:
- with sentinel lymph node technique (SLN) or axillary dissection;
- with or without immediate reconstruction using a prosthesis;
- associated or not with radiotherapy and/or chemotherapy;
- Presenting moderate to severe chronic neuropathic pain, defined by:
- Numerical Pain Scale (NPS) ≥ 3 and DN4 ≥ 4,
- on a localised aera ((≤ 240 cm²), at the surgical site, in the axillary hollow, or on the inner side of the ipsilateral arm,
- between 3 and 9 months after breast surgery,
- with indication of additional locoregional treatment in complement to a systemic treatment of chronic neuropathic pain, as recommended by the SFETD - French Society for the Study and Treatment of Pain (tricyclic...
- Patient affiliated with a health insurance plan;
- Patient informed and having consented to participate in the trial.
- Ipsilateral breast cancer recurrence, regardless of the first treatment;
- History of breast or thoracic surgery prior to mastectomy with residual pain;
- Painful polyneuropathy related to chemotherapy requiring treatment;
- Ongoing or planned loco-regional adjuvant radiotherapy within the next 8 weeks;
- Treatment area not suitable for potential botulinum toxin type A treatment;
- Breast reconstruction using flap or lipomodelling;
- Indication for breast reconstruction within the next 8 weeks;
- Chronic pain of another etiology such as:
- Neuropathic pain secondary to a neuroma (localized pain),
- Radiodermatitis,
- Phantom breast pain,
- Lymphedema,
- Complex regional pain syndrome,
- Adhesive capsulitis,
- Fibromyalgia;
- Hypersensitivity or allergy to anesthetics, capsaicin, naropein, clonidine hydrochloride, an amide-type local anesthetic, botulinum toxin type A, or any excipient contained in the preparations;
- Infection or inflammation at the injection site;
- Therapeutic/effective anticoagulation;
- Clinical signs or medical history leading to the diagnosis of:
- Hemostasis disorder,
- Local infection,
- Severe renal insufficiency (creatinine clearance \< 30 mL/min),
- Thrombocytopenia \< 50,000 platelets/mm3;
- Generalized muscle activity disorders (e.g., myasthenia, Lambert-Eaton syndrome);
- Heart rate lower than 60/minute;
- Severe bradyarrhythmia due to sick sinus syndrome or second or third-degree atrioventricular block;
- State of depression (HADS score ≥ 11);
- Other contraindication to any of the study treatments;
- Inability for the patient to follow the study schedule;
- Inability for the patient or the healthcare team to perform the treatment within 2 weeks;
- Pregnant or breastfeeding women, women who are able to conceive and who do not use a highly effective method of contraception during the trial and for at least 1 month after the end of treatment ;
- Patient under guardianship or curatorship.
The study team makes the final eligibility decision.
Where it's taking place
- Lille, Hauts-de-France, France
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The study runs about 24 months per participant, based on its public description. The team confirms the exact schedule and number of visits before you enroll.
Who can join this trial?
This study is enrolling female, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Lille, Hauts-de-France, France. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.