Serratus Plane Block (SPB) Versus Capsaïcine Versus Botox-A for Chronic Neuropathic Pain in Post-mastectomy Syndrome
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexFemale
Age18+
SponsorCentre Oscar Lambret
About this trial
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.
Eligibility criteria
Qualifiers
Women aged ≥ 18 years;
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;
Disqualifiers
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;
Trial design
Treatments tested in this trial
- Capsaicin 8% Patch
- Serratus Plane Block
- Botulinum Toxin A
Treatment groups
123 Participants
are divided into 3 treatment groupsSponsors and collaborators
Centre Oscar Lambret
Lead sponsor
Ligue contre le cancer, France
Collaborator
Santelys Association
Collaborator
CTD-CNO, Caen
Collaborator
Source ClinicalTrials.gov