Breast Cancer PatientPhase 3CAPTRANENCT03794388
Evaluation in the Treatment of Neuropathic Pain Post Breast Surgery
A Phase 3 study testing Capsaicin and Pregabalin in people with Breast Cancer Patient, run by Institut Cancerologie de l'Ouest at 11 sites in France.
Trial summary
Breast cancer is the most common cancer in women in Europe. Therefore, breast cancer has become a chronic disease and patients need to learn to live with it as well as with the adverse effects related to the disease itself or to the therapies used. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Breast Cancer Patient
- What is being tested?
- Capsaicin and Pregabalin
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 140 participants
- Where
- 11 sitesFrance
- Study dates
- 19 Mar 2019to 18 Nov 2022
- Phase
- Phase 3
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male or female who had first breast cancer surgery, regardless of the type of surgery
- Age ≥ 18 years
- Healthy, non-irritated skin on painful areas to treat
- During the inclusion visit to M4 post surgery, neuropathic pain of the breast and / or axillary area corresponding to inter-brachial neuralgia with a DN4≥4 score.
- Obtaining the signed written consent of the patient
- Major patient affiliated to a social security scheme
Who cannot join
- Contraindications specific to the treatments studied : capsaicine and pregabalin
- Diabetic patient
- Previous treatment with capsaicin or pregabalin
- Opioid treatment> 80 mg / day (oral morphine equivalent) in progress- Topical treatment of pain between surgery and inclusion visit
- Uncontrolled hypertension (systolic blood pressure ≥ 180 mmHg or diastolic blood pressure ≥ 90 mmHg) or recent history (<3 months) of cardiovascular events (stroke, heart attack, pulmonary embolism)
- Creatinine clearance (CLcr) <60mL / min according to the Cockcroft-Gault formula
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- Pregnant woman, likely to be pregnant or breastfeeding
- Persons deprived of their liberty or guardianship (including curators),
- Impossibility of submitting to the medical follow-up of the test for geographical, social or psychological reasons
Trial locations and contacts
11 sites in 1 country.
11 sites in 1 country
France11 sites
Institut de Cancerologie de L'Ouest
Angers, 49000
Chu Grenoble
Grenoble, 38700
Chd Vendee
La Roche-sur-Yon, 85025
Centre Oscar Lambret
Lille, 59020
Hopital Saint Vincent de Paul
Lille, 59020
Centre Leon Berard
Lyon, 69008
CHU NICE
Nice, 06003
Institut Jean Godinot
Reims, 51100
Institut Curie
Saint-Cloud, 92210
Iuct Oncopole
Toulouse, 31052
Ch Valenciennes
Valenciennes, 53322
About this study
Official title: Multicentric, Open, Randomized Study Comparing Topical Treatment by Patch of Capsaicin to 8% (Qutenza) to Pregabalin Oral in the Early Treatment of Neuropathic Pain After Primary Surgery for Breast Cancer
Breast cancer is the most common cancer in women in Europe. Therefore, breast cancer has become a chronic disease and patients need to learn to live with it as well as with the adverse effects related to the disease itself or to the therapies used.
As noted in the third "Plan cancer", pain is a major criterion in the quality of life of patients treated for breast cancer.
Read more
Neuropathic pain was defined in 2011 by the international Association for the Study of Pain (I.A.S.P.) as the direct result of a lesion or disease affecting the somato-sensory system.
Surgical treatment is often the first treatment of breast cancer. It can be conservative by performing a partial mastectomy (lumpectomy or quadrantectomy) or non-preservative by total mastectomy.
Intercostobrachial neuralgia (NICB) or Post mastectomy painful Syndrome (MPRR) was first described by Wood in 1978 as "chronic pain beginning immediately or early after a mastectomy" Or a lumpectomy affecting the anterior thorax, armpit and/or arm in its upper half. These post-surgical pains are related to a lesion of the nerves in the breast area.
In particular, the intercostobrachial nerve can be severed, stretched or crushed during surgery.
Post-operative neuropathic pain in patients with breast cancer is underdiagnosed either by general practitioner or in a specialized environment.
The diagnosis of neuropathic pain is performed during examination and clinical examination. Several scales allow to detect neuropathic pain but only the DN4 is recognized to be the most specific and sensitive scale.
Patients do not always express this pain. They do not always reconcile with the surgery. Either because the pain occurs a long time after the surgery, or they find it normal to get hurt. These diagnostic difficulties cause a delay in setting up a suitable analgesic treatment.
However, neuropathic pain responds poorly to common analgesics. Diagnosis, evaluation and early management of neuropathic pain are a priority in order to avoid their chronicization, to improve the quality of life of patients with breast cancer and to enable them to return to work quickly.
We therefore assume that the diagnosis of early neuropathic pain at 2 months of surgery associated with initiation of appropriate topical treatment without the systemic effects of conventional oral treatments, would reduce the incidence of Chronic neuropathic pain 6 months after surgery.
- Conditions
- Breast Cancer Patient
- Being tested
- Capsaicin, Pregabalin
- Keywords
- Breast cancer patient, Surgery, Inter Costobrachial Neuralgia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CapsaicinDrug
Also called qutenza EU/1/09/524/001
Application of capsaicin patches at 8% on painful area
PregabalinDrug
Also called Lyrica
Taking Pregabalin tablets
| Study group | Role | What they receive |
|---|---|---|
| Arm CAPSAICINE topical | Experimental | Application of capsaicin patches at 8% on the painful area
1 to 2 patches will be administered during the consultation. If necessary, a second application will be realized 3 months later. Receives: Drug: Capsaicin |
| Arm PREGABALINE | Active comparator | Pregabalin tablets will be initiated at a dose of 50 mg / day taken in 2 doses Depending on the tolerance, the dose will be increased to 100 mg / day and then to 150 mg / day to reach a maximum dose of 600 mg / day.
An interval of 3 to 7 days must be observed between each dose increase. Receives: Drug: Pregabalin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Neuropathic Pain Score at 2 Months (Numeric Rating Scale 0-10)
Pain intensity was assessed using an 11-point Numeric Rating Scale (NRS), ranging from 0 to 10, where:
- 0 indicates no pain,
- 10 indicates the worst imaginable pain. Higher scores represent worse pain. The score was collected at 2 months
Measured: 2 months
Secondary outcomes (1)
Change From Baseline to 6 Months in Neuropathic Pain Score (Numeric Rating Scale 0-10)
Neuropathic pain intensity was assessed using an 11-point Numeric Rating Scale (NRS) ranging from 0 to 10, where 0 indicates no pain and 10 indicates the worst imaginable pain.
The outcome measure represents the change in NRS score from baseline to 6 months, calculated as the score at 6 months minus the score at baseline.
Negative values indicate an improvement in pain, and positive values indicate worsening of pain.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jan 2019
- Study start19 Mar 2019
- Primary completion18 Nov 2022
- Study completion18 Nov 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Breast Cancer PatientStudies 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 3
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Multicenter, open, randomized study
- Masking
- None (open label)
- Enrolment
- 140 participants (actual)
Sponsor and investigators
- Lead sponsor
- Institut Cancerologie de l'Ouest
- Sponsor type
- University, hospital or other
- Collaborators
- Grünenthal GmbH
- Responsible party
- Sponsor
- Investigators
- DENIS DUPOIRON, MD, Study director, Institut de Cancérologie de l'Ouest
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03794388
- Sponsor's protocol ID
- ICO-A-2018-10
- Acronym
- CAPTRANE
- Status last verified
- Mar 2026
- First submitted
- 5 Nov 2018
- Last updated
- 5 May 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- 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 5 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Multicentric, Open, Randomized Study Comparing Topical Treatment by Patch of Capsaicin to 8% (Qutenza) to Pregabalin Oral in the Early Treatment of Neuropathic Pain After Primary Surgery for Breast Cancer
- ClinicalTrials.gov ID
- NCT03794388
- Acronym / sponsor ID
- CAPTRANE / ICO-A-2018-10
- Conditions
- Breast Cancer Patient
- Keywords
- Breast cancer patient, Surgery, Inter Costobrachial Neuralgia
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 140 participants (actual)
- Lead sponsor
- Institut Cancerologie de l'OuestUniversity, hospital or other
- Collaborators
- Grünenthal GmbH
- Study start
- 19 Mar 2019 (actual)
- Primary completion
- 18 Nov 2022 (actual)
- Study completion
- 18 Nov 2022 (actual)
- First posted
- 7 Jan 2019 (actual)
- Results
- Posted 5 May 2026
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Breast cancer is the most common cancer in women in Europe. Therefore, breast cancer has become a chronic disease and patients need to learn to live with it as well as with the adverse effects related to the disease itself or to the therapies used.
As noted in the third "Plan cancer", pain is a major criterion in the quality of life of patients treated for breast cancer.
Neuropathic pain was defined in 2011 by the international Association for the Study of Pain (I.A.S.P.) as the direct result of a lesion or disease affecting the somato-sensory system.
Surgical treatment is often the first treatment of breast cancer. It can be conservative by performing a partial mastectomy (lumpectomy or quadrantectomy) or non-preservative by total mastectomy.
Intercostobrachial neuralgia (NICB) or Post mastectomy painful Syndrome (MPRR) was first described by Wood in 1978 as "chronic pain beginning immediately or early after a mastectomy" Or a lumpectomy affecting the anterior thorax, armpit and/or arm in its upper half. These post-surgical pains are related to a lesion of the nerves in the breast area.
In particular, the intercostobrachial nerve can be severed, stretched or crushed during surgery.
Post-operative neuropathic pain in patients with breast cancer is underdiagnosed either by general practitioner or in a specialized environment.
The diagnosis of neuropathic pain is performed during examination and clinical examination. Several scales allow to detect neuropathic pain but only the DN4 is recognized to be the most specific and sensitive scale.
Patients do not always express this pain. They do not always reconcile with the surgery. Either because the pain occurs a long time after the surgery, or they find it normal to get hurt. These diagnostic difficulties cause a delay in setting up a suitable analgesic treatment.
However, neuropathic pain responds poorly to common analgesics. Diagnosis, evaluation and early management of neuropathic pain are a priority in order to avoid their chronicization, to improve the quality of life of patients with breast cancer and to enable them to return to work quickly.
We therefore assume that the diagnosis of early neuropathic pain at 2 months of surgery associated with initiation of appropriate topical treatment without the systemic effects of conventional oral treatments, would reduce the incidence of Chronic neuropathic pain 6 months after surgery.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Multicenter, open, randomized study
| Arm | Type | Receives |
|---|---|---|
| Arm CAPSAICINE topical | Experimental | Drug: CapsaicinApplication of capsaicin patches at 8% on the painful area 1 to 2 patches will be administered during the consultation. If necessary, a second application will be realized 3 months later. |
| Arm PREGABALINE | Active comparator | Drug: PregabalinPregabalin tablets will be initiated at a dose of 50 mg / day taken in 2 doses Depending on the tolerance, the dose will be increased to 100 mg / day and then to 150 mg / day to reach a maximum dose of 600 mg / day. An interval of 3 to 7 days must be observed between each dose increase. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Male or female who had first breast cancer surgery, regardless of the type of surgery
- Age ≥ 18 years
- Healthy, non-irritated skin on painful areas to treat
- During the inclusion visit to M4 post surgery, neuropathic pain of the breast and / or axillary area corresponding to inter-brachial neuralgia with a DN4≥4 score.
- Obtaining the signed written consent of the patient
Key exclusion criteria (9 listed)
- Contraindications specific to the treatments studied : capsaicine and pregabalin
- Diabetic patient
- Previous treatment with capsaicin or pregabalin
- Opioid treatment> 80 mg / day (oral morphine equivalent) in progress- Topical treatment of pain between surgery and inclusion visit
- Uncontrolled hypertension (systolic blood pressure ≥ 180 mmHg or diastolic blood pressure ≥ 90 mmHg) or recent history (<3 months) of cardiovascular events (stroke, heart attack, pulmonary embolism)
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 |
|---|---|---|
| CapsaicinAlso: qutenza EU/1/09/524/001Application of capsaicin patches at 8% on painful area | Drug | Arm CAPSAICINE topical |
| PregabalinAlso: LyricaTaking Pregabalin tablets | Drug | Arm PREGABALINE |
Primary outcome
Change in Neuropathic Pain Score at 2 Months (Numeric Rating Scale 0-10)
Time frame: 2 months
Pain intensity was assessed using an 11-point Numeric Rating Scale (NRS), ranging from 0 to 10, where: * 0 indicates no pain, * 10 indicates the worst imaginable pain. Higher scores represent worse pain. The score was collected at 2 months
1 secondary outcome
Change From Baseline to 6 Months in Neuropathic Pain Score (Numeric Rating Scale 0-10)
Time frame: 6 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 May 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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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.
DENIS DUPOIRON, MD study director
Institut de Cancérologie de l'Ouest
11 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Capsaicin and Pregabalin in people with Breast Cancer Patient, run by Institut Cancerologie de l'Ouest at 11 sites 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 6 inclusion and 9 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: finished, as of the sponsor's last update on 5 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 11 sites 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 5 May 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Change in Neuropathic Pain Score at 2 Months (Numeric Rating Scale 0-10) (time frame: 2 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 5 May 2026.