SerCaBot-2302 - Serratus Plane Block (SPB) versus Capsaicin versus Botulinum toxin type A for the chronic neuropathic pain of post-mastectomy syndrome

Overview

Sponsor-declared trial summary

Key facts

Sponsor

Centre Oscar Lambret

Participant type

Patients

Age range

18-64 years, 65+ years

Gender

Female

Therapeutic area

Diseases [C] - Neoplasms [C04]

Trial duration

10 Jun 2025 → ongoing

Decision date (initial)

2025-01-22

Transition trial

No

Low-intervention

Yes

Rare-disease indication

No

Vulnerable population

No

Funding sources

Ligue Nationale Contre le Cancer

External identifiers

EU CT number

2024-517420-20-00

ClinicalTrials.gov

NCT06807164

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

Scope: Efficacy

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.

Secondary objectives 9

1. To compare the three treatment groups (SPB, botulinum toxin type A, and capsaicin) in term of pain control at 8 weeks;
2. To compare the three treatment groups (SPB, botulinum toxin type A, and capsaicin) in terms of changes over time in pain scores collected up to 24 weeks after treatment
3. To compare the three treatment groups (SPB, botulinum toxin type A, and capsaicin) in terms of changes over time in the neuropathic component assessed by the NPSI
4. To compare the three treatment groups (SPB, botulinum toxin type A, and capsaicin) in terms of early failure of the local analgesic treatment;
5. To compare the three treatment groups (SPB, botulinum toxin type A, and capsaicin) in terms of the necessity to change the line of systemic treatment or to carry out Transcutaneous Electrical Neurostimulation (TENS) due to ineffectiveness;
6. To compare the three treatment groups (SPB, botulinum toxin type A, and capsaicin) in terms of patient-reported improvement using the Patient General Impression of Change (PGIC) self-questionnaire;
7. To compare the three treatment groups (SPB, botulinum toxin type A, and capsaicin) in terms of treatment safety;
8. To compare the three treatment groups (SPB, botulinum toxin type A, and capsaicin) in terms of depression and anxiety assessed by the HADS self-questionnaire;
9. To compare the three treatment groups (SPB, botulinum toxin type A, and capsaicin) in terms of quality of life assessed by the SF12 questionnaire.

Conditions and MedDRA coding

Chronic neuropathic pain of post-mastectomy syndrome

Eligibility criteria

Principal inclusion / exclusion criteria as submitted by sponsor

Inclusion criteria 5

1. Women aged ≥ 18 years old
2. 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;
3. 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.
4. Patient affiliated with a health insurance plan
5. Patient informed and consenting to participate in the trial

Exclusion criteria 21

1. Ipsilateral breast cancer recurrence, regardless of the first treatment
2. Infection or inflammation at the injection site
3. Curative/effective anticoagulation
4. 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
5. Generalized muscle activity disorders (e.g., myasthenia, Lambert-Eaton syndrome)
6. Heart rate lower than 60/minute
7. Severe bradyarrhythmia due to sick sinus syndrome or second or third-degree atrioventricular block
8. State of depression (HADS score ≥ 11)
9. Other contraindication to any of the study treatments
10. Inability for the patient to follow the study schedule
11. History of breast or thoracic surgery prior to mastectomy with residual pain
12. Painful polyneuropathy related to chemotherapy requiring treatment
13. Ongoing or planned loco-regional adjuvant radiotherapy within the next 8 weeks
14. Treatment area unsuitable for potential treatment with botulinum toxin type A
15. Breast reconstruction using flap or lipofilling
16. Indication for breast reconstruction within the next 8 weeks
17. 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
18. Hypersensitivity or allergy to anesthetics, capsaicin, naropaine, clonidine hydrochloride, amide-type local anesthetics, botulinum toxin type A, or any excipient contained in the preparations
19. Inability for the patient or the healthcare team to administer the treatment within 2 weeks
20. 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
21. Patients under guardianship or curatorship

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 1

1. The primary endpoint assesses pain through self-assessment using the Numerical Pain Scale (NPS), rated from 0 to 10, at 8 weeks after treatment or 9 weeks after randomization. If treatment fails before 8 weeks, assessment may occur earlier. Self-assessment is preferred as it reflects the individual's perception of treatment efficacy. If local treatment is interrupted, the baseline NPS measurement will be used for the primary analysis.

Secondary endpoints 9

1. Success in pain control at 8 weeks defined by a reduction in pain of 3 points or more, versus failure in other cases
2. Evolution of the NPS after treatment, self-assessed by the patient according to the same modalities as for the primary endpoint, at 1, 2, 4, 6, 8, and 24 weeks after treatment (and at 13, 14, 16, and 18 weeks in case of treatment repetition at 12 weeks); data collection is planned during pain management consultations and between these consultations through remote evaluations
3. Evolution of the neuropathic component, self-assessed via the NPSI questionnaire, at 1, 2, 4, 6, 8, and 24 weeks after treatment (and at 13, 14, 16, and 18 weeks in case of treatment repetition at 12 weeks)
4. Early failure of local analgesic treatment, defined by: - Treatment failure: interruption of the procedure (due to intolerance in the Capsaicin and Botox-A groups, and due to technical problems in the SPB group); - Failure in pain control assessed 7 and 14 days after the procedure (or earlier in case of a call, minimum 72 hours), defined by no improvement in the NPS leading to the need to introduce a new systemic antineuropathic treatment, or the need to resort to TENS
5. Modification or introduction of a new systemic analgesic treatment (gabapentinoid, tricyclic antidepressant, IRSNA, opioids) or TENS
6. Adverse events possibly related to the treatment performed (capsaicin, botulinum toxin type A, or SPB block), during the local procedure and afterwards, graded according to the NCI-CTCAE v5.0 scale. Pain leading to cessation of the procedure as well as a hematoma or pneumothorax of grade 2 or more will be considered severe adverse events
7. HADS scale, measured at baseline and during visits at 8 and 24 weeks
8. Quality of Life scale (Health Related QOL: SF-12) measured at baseline and during visits at 8 and 24 weeks
9. Patient General Impression of Change (PGIC) self-assessment scale from 1 (no change or worse) to 7 (considerable improvement making a clear difference), measured during visits at 8 and 24 weeks

Investigational products

Investigational medicinal products (IMPs), comparators, placebo, auxiliary

Test 3

Auxiliary 8

Sponsors and contacts

Sponsor organisations, regulatory contacts, third parties

Centre Oscar Lambret

Sponsor organisation

Centre Oscar Lambret

Address

3 Rue Frederic Combemale

City

Lille

Postcode

59000

Country

France

Scientific contact point

Organisation

Centre Oscar Lambret

Contact name

Clinical Research Sponsor Unit

Public contact point

Organisation

Centre Oscar Lambret

Contact name

Clinical Research Sponsor Unit

Locations

1 EU/EEA country · 1 investigational sites

By country

Investigational sites

Country notifications

Trial-start, recruitment-start, end and early-termination notifications submitted per Member State

Results and documents

Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial

Documents 18 files

Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.

Application history

2 submissions — initial application plus substantial / non-substantial modifications