Condition: Post-Mastectomy Neuropathic Pain Syndrome · Sponsor: Centre Oscar Lambret
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.
This description comes directly from the study's public registry record.
Julien THERY, Project manager · +33 (0)3 20 29 59 18 · j-thery@o-lambret.fr
Victor DESTEIRDT, Clinical Research Associate-M · +33 (0)3 20 29 59 18 · v-desteirdt@o-lambret.fr
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| Centre Oscar Lambret | Lille, Hauts-de-France, France | Recruiting |
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Source record: clinicaltrials.gov/study/NCT06807164