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Serratus Plane Block (SPB) Versus Capsaïcine Versus Botox-A for Chronic Neuropathic Pain in Post-mastectomy Syndrome

Study acronym: SERCABOT
StatusWithdrawn
PhasePhase 2
Started
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Record History

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  1. Trial status changed: Recruiting → Withdrawn Sponsor's reason: No recruitment Show 4 more changesShow less
    • Enrollment target: estimated 123 to confirmed 0
    • Primary completion date changed from estimate of Aug 30, 2027 to Sep 22, 2026
    • Start date changed from estimate of Oct 31, 2026 to Jun 10, 2025
    • Site details revised
  2. Start date: Mar 31, 2026 to Oct 31, 2026
    • Eligibility criteria expanded, about 44 words
    • Study description expanded, about 6 words
  3. Re-verified, no change to tracked fieldsv5
  4. Start date: Jun 30, 2025 to Mar 31, 2026v4
  5. Trial status: Not Yet Recruiting to Recruitingv3 Show 7 more changesShow less
    • Primary completion date: Feb 1, 2027 to Aug 30, 2027
    • Start date: Feb 1, 2025 to Jun 30, 2025
    • Study completion date: Aug 1, 2027 to Dec 30, 2027
    • Secondary endpoints revised (9)
    • Study description expanded, about 25 words
    • Site details revised
    • Eligibility criteria expanded, about 1 word
  6. Site contact updated
    • Collaborators: 4 to 3
    v2
  7. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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. 123 patients with chronic neuropathic pain of post-mastectomy syndrom insufficiently relieved by systemic treatment alone will be recruited over 24 months at the Centre Oscar Lambret. Patients will be randomly assigned to one of three treatment groups (41 patients per group): Capsaicin Botulinum toxin A SPB Patients will be followed for 24 weeks after the study treatment. The follow-up will include remote evaluation and 2 medical visits during which pain and quality of life will be assessed.
Trial Details
NCT Number NCT06807164
Lead Sponsor Centre Oscar Lambret
Collaborators: Ligue contre le cancer, France, Santelys Association, CTD-CNO, Caen
Conditions
(from sponsor)		 Post-Mastectomy Neuropathic Pain Syndrome
Related terms Agnosia, Breast Neoplasms
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov