Post-Mastectomy Neuropathic Pain SyndromePhase 2SERCABOTNCT06807164

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

A Phase 2 study testing Capsaicin 8% Patch, Serratus Plane Block and Botulinum Toxin A in people with Post-Mastectomy Neuropathic Pain Syndrome, run by Centre Oscar Lambret at 1 site in France.

Withdrawn

Withdrawn. The study stopped before anyone enrolled.

Official record

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Trial summary

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. Read more about this study

Who is it for?: Ages 18 years and older, women only
Conditions the study is for: Post-Mastectomy Neuropathic Pain Syndrome
What is being tested?: Capsaicin 8% Patch, Serratus Plane Block and Botulinum Toxin A
Type of treatment: Pill or oral medicine, Injection or infusion, Surgery or procedure
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 0 participants
Where: 1 siteFrance
Study dates: 10 Jun 2025to 22 Sep 2026
Phase: Phase 2
Are there results?: None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
Women only
No healthy volunteers
Adult, Older adult

Who may be able to join

Women aged ≥ 18 years;
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;
Presenting moderate to severe chronic neuropathic pain, defined by:

Show all 12Show fewer

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;
Patient affiliated with a health insurance plan;
Patient informed and having consented to participate in the trial.

Who cannot join

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;
Treatment area not suitable for potential botulinum toxin type A treatment;
Breast reconstruction using flap or lipomodelling;

Show all 32Show fewer

Indication for breast reconstruction within the next 8 weeks;
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;
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;
Infection or inflammation at the injection site;
Therapeutic/effective anticoagulation;
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;
Generalized muscle activity disorders (e.g., myasthenia, Lambert-Eaton syndrome);
Heart rate lower than 60/minute;
Severe bradyarrhythmia due to sick sinus syndrome or second or third-degree atrioventricular block;
State of depression (HADS score ≥ 11);
Other contraindication to any of the study treatments;
Inability for the patient to follow the study schedule;
Inability for the patient or the healthcare team to perform the treatment within 2 weeks;
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 ;
Patient under guardianship or curatorship.

Trial locations and contacts

1 site in 1 country.

France1 site

Centre Oscar Lambret
Lille, Hauts-de-France, 59000

Other trials in France

About this study

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.

Read the detailed description

SerCaBot is a randomized, open-label, phase II clinical trial designed to evaluate the efficacy of a treatment with Serratus Plane Block (SPB) or Botox-A compared to capsaicin for the control of chronic neuropathic pain of post-mastectomy syndrom, that is not adequately managed by systemic treatment alone.

123 patients with will be recruited over 24 months at the Centre Oscar Lambret.

This clinical trial will be proposed to patients with chronic neuropathic pain of post-mastectomy syndrome that is not adequately managed by systemic treatment alone.

After consent, an inclusion assessment will be carried out including clinical examination, anamnesis, pain assessment (questionnaires PCS, NPS, DN4, NPSI and collect of antalgic treatment) and evaluation of quality of life (questionnaire SF12) and depression (questionnaire HADS).

Patients will then be randomly assigned to one of three treatment groups : Capsaicin, Botox-A, SPB (41 patients per group). The randomization will be balanced 1:1:1, controlled by minimisation (with a random factor set at 0.8) for the distribution of the following factors:

Pain level at enrolment (continuous NPS)
Axillary dissection (yes vs. no)
Loco-regional adjuvant radiotherapy (yes vs. no)
Prior change of systemic treatment (yes vs. no)

The study treatment will be administered 1 to 2 weeks after randomization. Treatment will be stopped prematurely in the event of unacceptable toxicity or complication. In each group, a repeat of the treatment may be considered after 12 weeks if further pain control is required. In the SPB group, a repeat is also possible every 2 weeks.

Patients will be followed for 24 weeks after the study treatment. Follow-up will include:

2 medical visits at 8 weeks and at 24 weeks including pain assessment (questionnaires NPS, NPSI, record of antalgic treatment), record of adverse events related to study treatment and assessment of quality of life (SF12 questionnaire) and depression (questionnaire HADS).
remote assessment at week-1, week-2, week-4 and week-6 including assessment of pain (questionnaires NPS, NPSI, record of antalgic treatment) and record of adverse events. This remote assessment will be repeated in case of repetition of treatment at week 12.

Patients will withdraw from the study after the 24 week medical visit. Early withdrawal will be possible in case of patient's decision of withdrawal, breast surgery during follow-up, or death.

Conditions: Post-Mastectomy Neuropathic Pain Syndrome
Being tested: Capsaicin 8% Patch, Serratus Plane Block, Botulinum Toxin A
Keywords: Breast cancer, Chronic neuropathic pain, Post-mastectomy pain, Serratus Plane Block (SPB), Capsaicin, Pain management, Botulinum toxin type A
Medical subject headings: Breast Neoplasms, Agnosia

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Capsaicin 8% PatchDrug
Also called Qutenza®
One or two capsaicin patch (8%) are applied for 60 minutes to the site of neuropathic pain, in day-hospital. An oral, antalgic pre-medication may be done with one of the following medications (alone or association): paracetamol 1g, nefopam 30 mg, tramadol 100 mg, morphine 10mg, oxycodone 5mg. Capsaicin will be administered in addition to a systemic treatment that has been ongoing for at least 4 weeks. If pain persists, the capsaicin patch application may be repeated at 12 weeks.
Serratus Plane BlockProcedure or surgery
Also called SPB
The Serratus Plane Block (SPB) is a nerve block performed by a trained anesthesiologist to provide localized pain relief. It involves the injection of a local anesthetic: Maximum 150 mg naropeine combined with 150 μg clonidine hydrochloride into the serratus anterior plane under ultrasound guidance. An anesthesiologist will perform the procedure in a post-interventional recovery room, with light sedation.The SBP will be carried out in addition to a systemic treatment that has been ongoing for at least 4 weeks. The SPB may be repeated every two weeks up to four times in the initial 8-week period, with an additional repeat at 12 weeks if pain control remains insufficient.
Botulinum Toxin AProcedure or surgery
Also called Botox-A, Botox
Botulinum Toxin A (Botox-A) is injected into the affected area, with a total of 300 units administered across up to 60 injection sites. An anesthesiologist will perform the procedure in a post-interventional recovery room, with light sedation. This intervention will be carried out in addition to a systemic treatment that has been ongoing for at least 4 weeks, and is aimed at providing prolonged pain relief for post-mastectomy neuropathic pain. Light sedation is provided, and injections may be repeated at 12 weeks if necessary.

Study groups in NCT06807164
Study group	Role	What they receive
Capsaicin 8% Patch (Control)	Active comparator	Participants in this arm will receive an 8% capsaicin patch in a single treatment session in addition to a systemic treatment that has been ongoing for at least 4 weeks. If pain persists, the capsaicin patch application may be repeated at 12 weeks. Receives: Drug: Capsaicin 8% Patch
Serratus Plane Block (SPB)	Experimental	Participants in this arm will undergo a Serratus Plane Block (SPB), a local anesthetic injection administered by a trained anesthesiologist, in addition to a systemic treatment that has been ongoing for at least 4 weeks. The SPB can be repeated every two weeks up to a maximum of four sessions within the initial 8-week period if pain persists. A repeat treatment may be considered at 12 weeks if further pain control is needed. This intervention aims to provide extended pain relief for neuropathic pain in post-mastectomy patients Receives: Procedure: Serratus Plane Block
Botulinum Toxin A (Botox-A) Injection	Experimental	This arm involves administration of Botulinum Toxin A (Botox-A) at the site of pain, in addition to a systemic treatment that has been ongoing for at least 4 weeks. If pain remains unresolved, the injection may be repeated at 12 weeks. Botox-A is used here as a local, long-lasting analgesic intervention aimed at reducing chronic neuropathic pain in patients post-mastectomy. Receives: Procedure: Botulinum Toxin A

What is being measured

The primary outcome is the main question the study is designed to answer.

Pain assessment using Numerical Pain Scale (END)
The primary outcome measure is pain assessed by self-evaluation using the Numerical Pain Scale (END) ranging from 0 (no pain) to 10 (worst pain imaginable) at rest, evaluated 8 weeks after treatment (or 9 weeks after randomization if treatment was not performed). The patient's self-assessment reflects individual treatment efficacy. In case of treatment interruption due to immediate intolerance or technical issues, the baseline END will be considered for the primary analysis.
Measured: 8 weeks after treatment initiation, or the closest measurement within +/- 1 week if the 8-week data is missing.

Secondary outcomes (9)

Success of Pain Control
Defined as a reduction in pain of 3 points or more on the Numerical Pain Scale (END) at 8 weeks, with failure indicated in other cases.
Measured: Assessed at 8 weeks post-treatment.
Evolution of Pain Scores
Change in pain levels as self-reported by the patient using the END at 1, 2, 4, 6, 8, and 24 weeks after treatment (and at 13, 14, 16, and 18 weeks if treatment is repeated at 12 weeks).
Measured: Assessed at multiple time points: 1, 2, 4, 6, 8, and 24 weeks.
Neuropathic Component Evaluation
Change in neuropathic symptoms assessed via the Neuropathic Pain Symptom Inventory (NPSI) at 1, 2, 4, 6, 8, and 24 weeks after treatment (and at 13, 14, 16, and 18 weeks if treatment is repeated at 12 weeks).
Measured: Assessed at multiple time points: 1, 2, 4, 6, 8, and 24 weeks.
Early Treatment Failure
Early failure of local analgesic treatment defined by failure to perform the procedure (due to intolerance or technical issues) or failure to control pain as evaluated at 7 and 14 days post-procedure.
Measured: Assessed at 7 and 14 days post-treatment
Modification of introduction of New Analgesic Treatment
Documentation of any change in systemic treatement or introduction of new analgesic treatments (e.g., antiepileptics, antidepressants, opioids), with dosages collected at 1, 2, 4, 6, 8, and 24 weeks after treatment (and at 13, 14, 16, and 18 weeks if treatment is repeated).
Measured: Assessed at multiple time points: 1, 2, 4, 6, 8, and 24 weeks.
Adverse Events
Monitoring of adverse events possibly related to the treatment (capsaicin, botulinum toxin type A, or SBP block) during and after the local procedure, graded according to NCI-CTCAE v5.0.
Measured: From study treatment to 24-weeks follow-up
HADS Scale Evaluation
Assessment of anxiety and depression using the Hospital Anxiety and Depression Scale (HADS) at baseline, 8 weeks, and 24 weeks.
Measured: Assessed at baseline, 8 weeks, and 24 weeks.
Quality of Life Assessment
Evaluation of health-related quality of life using the SF12 scale at baseline, 8 weeks, and 24 weeks.
Measured: Assessed at baseline, 8 weeks, and 24 weeks.
Patient General Impression of Change (PGIC)
Self-assessment of change in condition from 1 (no change or worse) to 7 (considerable improvement) measured at 8 weeks and 24 weeks.
Measured: Assessed at 8 weeks and 24 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

10 Jun 202522 Sep 2026

First posted4 Feb 2025
Study start10 Jun 2025
Primary completion22 Sep 2026
Study completion22 Sep 2026

Why it stopped: No recruitment

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for Post-Mastectomy Neuropathic Pain SyndromeStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 2
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Model description: Phase 2, randomized clinical trial, open-label, evaluating 3 interventions : Capsaicin, Botox-A, SPB
Masking: None (open label)
Enrolment: 0 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT06807164
Sponsor's protocol ID: SERCABOT-2302
Other IDs: 2024-517420-20-00
Acronym: SERCABOT
Status last verified: Oct 2026
First submitted: 29 Jan 2025
Last updated: 6 Oct 2026
Results posted: No
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No

Study at a glance

From the registry record, last updated by the sponsor on 6 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Serratus Plane Block (SPB) Versus Capsaïcine Versus Botox-A for Chronic Neuropathic Pain in Post-mastectomy Syndrome
ClinicalTrials.gov ID: NCT06807164
Acronym / sponsor ID: SERCABOT / SERCABOT-2302
Conditions: Post-Mastectomy Neuropathic Pain Syndrome
Keywords: Breast cancer, Chronic neuropathic pain, Post-mastectomy pain, Serratus Plane Block (SPB), Capsaicin, Pain management, Botulinum toxin type A
Phase: Phase 2
Study type: Interventional
Recruitment status: WithdrawnReason stopped: No recruitment
Enrolment: 0 participants (actual)
Lead sponsor: Centre Oscar LambretUniversity, hospital or other
Collaborators: Ligue contre le cancer, France, Santelys Association, CTD-CNO, Caen
Study start: 10 Jun 2025 (actual)
Primary completion: 22 Sep 2026 (actual)
Study completion: 22 Sep 2026 (actual)
First posted: 4 Feb 2025 (actual)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

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.

Detailed description

123 patients with will be recruited over 24 months at the Centre Oscar Lambret.

This clinical trial will be proposed to patients with chronic neuropathic pain of post-mastectomy syndrome that is not adequately managed by systemic treatment alone.

Pain level at enrolment (continuous NPS)
Axillary dissection (yes vs. no)
Loco-regional adjuvant radiotherapy (yes vs. no)
Prior change of systemic treatment (yes vs. no)

Patients will be followed for 24 weeks after the study treatment. Follow-up will include:

2 medical visits at 8 weeks and at 24 weeks including pain assessment (questionnaires NPS, NPSI, record of antalgic treatment), record of adverse events related to study treatment and assessment of quality of life (SF12 questionnaire) and depression (questionnaire HADS).
remote assessment at week-1, week-2, week-4 and week-6 including assessment of pain (questionnaires NPS, NPSI, record of antalgic treatment) and record of adverse events. This remote assessment will be repeated in case of repetition of treatment at week 12.

Patients will withdraw from the study after the 24 week medical visit. Early withdrawal will be possible in case of patient's decision of withdrawal, breast surgery during follow-up, or death.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 3
Model description: Phase 2, randomized clinical trial, open-label, evaluating 3 interventions : Capsaicin, Botox-A, SPB

Arm	Type	Receives
Capsaicin 8% Patch (Control)	Active comparator	Drug: Capsaicin 8% PatchParticipants in this arm will receive an 8% capsaicin patch in a single treatment session in addition to a systemic treatment that has been ongoing for at least 4 weeks. If pain persists, the capsaicin patch application may be repeated at 12 weeks.
Serratus Plane Block (SPB)	Experimental	Procedure: Serratus Plane BlockParticipants in this arm will undergo a Serratus Plane Block (SPB), a local anesthetic injection administered by a trained anesthesiologist, in addition to a systemic treatment that has been ongoing for at least 4 weeks. The SPB can be repeated every two weeks up to a maximum of four sessions within the initial 8-week period if pain persists. A repeat treatment may be considered at 12 weeks if further pain control is needed. This intervention aims to provide extended pain relief for neuropathic pain in post-mastectomy patients
Botulinum Toxin A (Botox-A) Injection	Experimental	Procedure: Botulinum Toxin AThis arm involves administration of Botulinum Toxin A (Botox-A) at the site of pain, in addition to a systemic treatment that has been ongoing for at least 4 weeks. If pain remains unresolved, the injection may be repeated at 12 weeks. Botox-A is used here as a local, long-lasting analgesic intervention aimed at reducing chronic neuropathic pain in patients post-mastectomy.

Who may qualify

Ages: 18 years and older
Sex: Female only
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (12 listed)

Women aged ≥ 18 years;
Unilateral breast cancer treated by total or partial mastectomy:
Presenting moderate to severe chronic neuropathic pain, defined by:
Patient affiliated with a health insurance plan;
Patient informed and having consented to participate in the trial.

Key exclusion criteria (32 listed)

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;
Treatment area not suitable for potential botulinum toxin type A treatment;

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Capsaicin 8% PatchAlso: Qutenza®One or two capsaicin patch (8%) are applied for 60 minutes to the site of neuropathic pain, in day-hospital. An oral, antalgic pre-medication may be done with one of the following medications (alone or association): paracetamol 1g, nefopam 30 mg, tramadol 100 mg, morphine 10mg, oxycodone 5mg. Capsaicin will be administered in addition to a systemic treatment that has been ongoing for at least 4 weeks. If pain persists, the capsaicin patch application may be repeated at 12 weeks.	Drug	Capsaicin 8% Patch (Control)
Serratus Plane BlockAlso: SPBThe Serratus Plane Block (SPB) is a nerve block performed by a trained anesthesiologist to provide localized pain relief. It involves the injection of a local anesthetic: Maximum 150 mg naropeine combined with 150 μg clonidine hydrochloride into the serratus anterior plane under ultrasound guidance. An anesthesiologist will perform the procedure in a post-interventional recovery room, with light sedation.The SBP will be carried out in addition to a systemic treatment that has been ongoing for at least 4 weeks. The SPB may be repeated every two weeks up to four times in the initial 8-week period, with an additional repeat at 12 weeks if pain control remains insufficient.	Procedure or surgery	Serratus Plane Block (SPB)
Botulinum Toxin AAlso: Botox-A, BotoxBotulinum Toxin A (Botox-A) is injected into the affected area, with a total of 300 units administered across up to 60 injection sites. An anesthesiologist will perform the procedure in a post-interventional recovery room, with light sedation. This intervention will be carried out in addition to a systemic treatment that has been ongoing for at least 4 weeks, and is aimed at providing prolonged pain relief for post-mastectomy neuropathic pain. Light sedation is provided, and injections may be repeated at 12 weeks if necessary.	Procedure or surgery	Botulinum Toxin A (Botox-A) Injection

Primary outcome

Pain assessment using Numerical Pain Scale (END)
Time frame: 8 weeks after treatment initiation, or the closest measurement within +/- 1 week if the 8-week data is missing.
The primary outcome measure is pain assessed by self-evaluation using the Numerical Pain Scale (END) ranging from 0 (no pain) to 10 (worst pain imaginable) at rest, evaluated 8 weeks after treatment (or 9 weeks after randomization if treatment was not performed). The patient's self-assessment reflects individual treatment efficacy. In case of treatment interruption due to immediate intolerance or technical issues, the baseline END will be considered for the primary analysis.

9 secondary outcomes

Success of Pain Control
Time frame: Assessed at 8 weeks post-treatment.
Evolution of Pain Scores
Time frame: Assessed at multiple time points: 1, 2, 4, 6, 8, and 24 weeks.
Neuropathic Component Evaluation
Time frame: Assessed at multiple time points: 1, 2, 4, 6, 8, and 24 weeks.
Early Treatment Failure
Time frame: Assessed at 7 and 14 days post-treatment
Modification of introduction of New Analgesic Treatment
Time frame: Assessed at multiple time points: 1, 2, 4, 6, 8, and 24 weeks.
Adverse Events
Time frame: From study treatment to 24-weeks follow-up
HADS Scale Evaluation
Time frame: Assessed at baseline, 8 weeks, and 24 weeks.
Quality of Life Assessment
Time frame: Assessed at baseline, 8 weeks, and 24 weeks.
Patient General Impression of Change (PGIC)
Time frame: Assessed at 8 weeks and 24 weeks

Results and safety

The study was withdrawn before enrolling participants, so there are no results.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 6 Oct 2026.
Individual participant dataSharing planned: No

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Didier DELBROUCK, Anesthesiologist principal investigator

Centre Oscar Lambret

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Capsaicin 8% Patch, Serratus Plane Block and Botulinum Toxin A in people with Post-Mastectomy Neuropathic Pain Syndrome, run by Centre Oscar Lambret at 1 site in France.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 12 inclusion and 32 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: withdrawn, as of the sponsor's last update on 6 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study was withdrawn before enrolling participants, so there are no results.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Pain assessment using Numerical Pain Scale (END) (time frame: 8 weeks after treatment initiation, or the closest measurement within +/- 1 week if the 8-week data is missing.). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06807164.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Oct 2026.