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New hope for breast cancer survivors: study tests three pain-blocking treatments

NCT ID NCT06807164

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Sep 18, 2026 · Updated 2 times

Summary

This study tests three treatments—a nerve block (SPB), Botox, and capsaicin—to see which works best for chronic nerve pain after mastectomy. 123 women whose pain is not controlled by standard medicines will be randomly assigned to one of the three groups. The main goal is to measure pain relief 8 weeks after treatment.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

About 123 people

The number the study aims to enrol. It can still change while the study runs.

Expected to start

Oct 2026

An estimate. Start dates often move.

Expected to finish

Dec 2027

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Female participants only

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria : 1. Women aged ≥ 18 years; 2. Unilateral breast cancer treated by total or partial mastectomy: * 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; 3. Presenting moderate to severe chronic neuropathic pain, defined by: * Numerical Pain Scale (NPS) ≥ 3 and DN4 ≥ 4, * on a localised aera ((≤ 240 cm²), at the surgical site, in the axillary hollow, or on the inner side of the ipsilateral arm, * between 3 and 9 months after breast surgery, * with indication of additional locoregional treatment in complement to a systemic treatment of chronic neuropathic pain, as recommended by the SFETD - French Society for the Study and Treatment of Pain (tricyclic antidepressants or IRSNA or gabapentinoid PLUS lidocaine patch, at the appropriate dosage) and implemented for at least 4 weeks; 4. Patient affiliated with a health insurance plan; 5. Patient informed and having consented to participate in the trial. Exclusion Criteria : 1. Ipsilateral breast cancer recurrence, regardless of the first treatment; 2. History of breast or thoracic surgery prior to mastectomy with residual pain; 3. Painful polyneuropathy related to chemotherapy requiring treatment; 4. Ongoing or planned loco-regional adjuvant radiotherapy within the next 8 weeks; 5. Treatment area not suitable for potential botulinum toxin type A treatment; 6. Breast reconstruction using flap or lipomodelling; 7. Indication for breast reconstruction within the next 8 weeks; 8. Chronic pain of another etiology such as: * Neuropathic pain secondary to a neuroma (localized pain), * Radiodermatitis, * Phantom breast pain, * Lymphedema, * Complex regional pain syndrome, * Adhesive capsulitis, * Fibromyalgia; 9. Hypersensitivity or allergy to anesthetics, capsaicin, naropein, clonidine hydrochloride, an amide-type local anesthetic, botulinum toxin type A, or any excipient contained in the preparations; 10. Infection or inflammation at the injection site; 11. Therapeutic/effective anticoagulation; 12. Clinical signs or medical history leading to the diagnosis of: * Hemostasis disorder, * Local infection, * Severe renal insufficiency (creatinine clearance \< 30 mL/min), * Thrombocytopenia \< 50,000 platelets/mm3; 13. Generalized muscle activity disorders (e.g., myasthenia, Lambert-Eaton syndrome); 14. Heart rate lower than 60/minute; 15. Severe bradyarrhythmia due to sick sinus syndrome or second or third-degree atrioventricular block; 16. State of depression (HADS score ≥ 11); 17. Other contraindication to any of the study treatments; 18. Inability for the patient to follow the study schedule; 19. Inability for the patient or the healthcare team to perform the treatment within 2 weeks; 20. Pregnant or breastfeeding women, women who are able to conceive and who do not use a highly effective method of contraception during the trial and for at least 1 month after the end of treatment ; 21. Patient under guardianship or curatorship.

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Conditions

The condition(s) this trial relates to.

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    1 site. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Centre Oscar Lambret

    RECRUITING

    Lille, Hauts-de-France, 59000, France