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SerCaBot-2302 - Serratus Plane Block (SPB) versus Capsaicin versus Botulinum toxin type A for the chronic neuropathic pain of post-mastectomy syndrome
EU CTIS ID: 2024-517420-20-00
What this study is testing
To evaluate the efficacy of a locoregional treatment using either SPB or Botox-A, compared to an 8% capsaicin patch, in combination with systemic treatment (+/- lidocaine patch), for the management of chronic neuropathic pain associated with post-mastectomy pain syndrome that is inadequately relieved by systemic treatment alone (+/- lidocaine patch), with the primary endpoint being the assessment at 8 weeks.
- Therapeutic exploratory (Phase II)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- Women aged ≥ 18 years old
- Unilateral breast cancer treated with total or partial mastectomy: - using sentinel lymph node technique (SLN) or axillary dissection; - with or without immediate breast reconstruction using a prosthesis; - associated or not with radiotherapy and/or chemotherapy;
- Patient presenting with at least moderate chronic neuropathic pain, defined by: NRS (Numerical Rating Scale) ≥ 3 and DN4 ≥ 4, Pain confined to a well-localized area (≤ 240 cm²) at the surgical site, in the axillary hollow, or on the inner side of the ipsilateral arm, Occurring between 3 and 9 months post-breast surgery, With indication for add-on locoregional therapy to a systemic treatment for chronic neuropathic pain, as recommended by the SFETD (French Society for the Study and Treatment of Pain)— tricyclic antidepressants, SNRIs, or a gabapentinoid at an appropriate dosage, plus a lidocaine patch—which has been in place and stable for at least 4 weeks.
- Patient affiliated with a health insurance plan
- Patient informed and consenting to participate in the trial
You likely can't join if
- Ipsilateral breast cancer recurrence, regardless of the first treatment
- Inability for the patient to follow the study schedule
- 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 unsuitable for potential treatment with botulinum toxin type A
See the full eligibility criteria
- Women aged ≥ 18 years old
- Unilateral breast cancer treated with total or partial mastectomy: - using sentinel lymph node technique (SLN) or axillary dissection; - with or without immediate breast reconstruction using a prosthesis; - associated or not with radiotherapy and/or chemotherapy;
- Patient presenting with at least moderate chronic neuropathic pain, defined by: NRS (Numerical Rating Scale) ≥ 3 and DN4 ≥ 4, Pain confined to a well-localized area (≤ 240 cm²) at the surgical site, in the axillary hollow, or on the inner side of the ipsilateral arm, Occurring between 3 and 9 months post-breast surgery, With indication for add-on locoregional therapy to a systemic treatment for chronic neuropathic pain, as recommended by the SFETD (French Society for the Study and Treatment of Pain)— tricyclic antidepressants, SNRIs, or a gabapentinoid at an appropriate dosage, plus a lidocaine patch—which has been in place and stable for at least 4 weeks.
- Patient affiliated with a health insurance plan
- Patient informed and consenting to participate in the trial
- Ipsilateral breast cancer recurrence, regardless of the first treatment
- Inability for the patient to follow the study schedule
- 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 unsuitable for potential treatment with botulinum toxin type A
- Breast reconstruction using flap or lipofilling
- Indication for breast reconstruction within the next 8 weeks
- Chronic pain of other 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, naropaine, clonidine hydrochloride, amide-type local anesthetics, botulinum toxin type A, or any excipient contained in the preparations
- Inability for the patient or the healthcare team to administer the treatment within 2 weeks
- Infection or inflammation at the injection site
- Pregnant or breastfeeding women, women of childbearing potential not using a highly effective method of contraception during the trial and for at least 1 month after the end of treatment
- Patients under guardianship or curatorship
- Curative/effective anticoagulation
- Clinical signs or medical history leading to the diagnosis of: - Hemostatic disorders, - 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
The study team makes the final eligibility decision.
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 listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling female, 65+ years, 18-64 years. The study team makes the final eligibility decision.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.