A Phase 3 interventional study of Capsaicin and Pregabalin in Breast Cancer Patient, sponsored by Institut Cancerologie de l'Ouest. Completed at 11 sites in France. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-05-05.
Sponsored by Institut Cancerologie de l'Ouest · Phase 3, Interventional, and Supportive care
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.
Institut Cancerologie de l'Ouest is the lead sponsor of 105 studies on the registry; 18 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
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.
Drug: Capsaicin
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.
Drug: Pregabalin
Application of capsaicin patches at 8% on painful area
Also known as: qutenza EU/1/09/524/001
Taking Pregabalin tablets
Also known as: Lyrica
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
Time frame: 2 months
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.
Time frame: 6 months
| Milestone | Arm CAPSAICINE Topical | Arm PREGABALINE |
|---|---|---|
| Started | 70 | 70 |
| Completed | 65 | 51 |
| Not completed | 5 | 19 |
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
| units on a scale | Arm CAPSAICINE Topical | Arm PREGABALINE |
|---|---|---|
| Change in Neuropathic Pain Score at 2 Months (Numeric Rating Scale 0-10) | 4.1 ± 2.5 | 4.6 ± 2.9 |
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.
| units | Experimental ARM | Control ARM |
|---|---|---|
| Change From Baseline to 6 Months in Neuropathic Pain Score (Numeric Rating Scale 0-10) | -2.2 ± 2.5 | -2.7 ± 2.9 |
Collected over 6 months. Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Arm CAPSAICINE Topical | 0/65 (0%) | 0/65 (0%) | 8/65 (12.3%) |
| Arm PREGABALINE | 0/51 (0%) | 0/51 (0%) | 29/51 (56.9%) |
| Event | Arm CAPSAICINE Topical | Arm PREGABALINE |
|---|---|---|
| VertigoNervous system disorders | 0/65 | 8/51 |
| Application site burningInjury, poisoning and procedural complications | 8/65 | 4/51 |
| HeadacheNervous system disorders | 0/65 | 5/51 |
| SomnolenceNervous system disorders | 0/65 | 5/51 |
| ConfusionNervous system disorders | 0/65 | 4/51 |
| InsomniaNervous system disorders | 0/65 | 3/51 |
| Age, Categorical(Participants) | Arm CAPSAICINE Topical | Arm PREGABALINE | Total |
|---|---|---|---|
| <=18 years | 0 | 0 | 0 |
| Between 18 and 65 years | 49 | 39 | 88 |
| >=65 years | 16 | 12 | 28 |
| Sex: Female, Male(Participants) | Arm CAPSAICINE Topical | Arm PREGABALINE | Total |
|---|---|---|---|
| Female | 65 | 51 | 116 |
| Male | 0 | 0 | 0 |
| Race/Ethnicity, Customized(Participants) | Arm CAPSAICINE Topical | Arm PREGABALINE | Total |
|---|---|---|---|
| Not Reported | 65 | 51 | 116 |
| Region of Enrollment(participants) | Arm CAPSAICINE Topical | Arm PREGABALINE | Total |
|---|---|---|---|
| France | 65 | 51 | 116 |
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Institut Cancerologie de l'Ouest