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Completed

NCT Number: NCT03794388

Evaluation in the Treatment of Neuropathic Pain Post Breast Surgery

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Institut de Cancerologie de L'Ouest, Angers, France

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

  • 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
  • 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

Treatment and study plan

Capsaicin

Drug

Application of capsaicin patches at 8% on painful area

Other names: qutenza EU/1/09/524/001

Pregabalin

Drug

Taking Pregabalin tablets

Other names: Lyrica

Primary outcomes

  1. 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

Secondary outcomes

  1. Change From Baseline to 6 Months in Neuropathic Pain Score (Numeric Rating Scale 0-10)

    Time frame: 6 months

    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.

Sponsors and collaborators

Lead sponsor

Institut Cancerologie de l'Ouest

Other

Collaborators

  • Grünenthal GmbH

Registry information

Official study 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

Acronym: CAPTRANE

Important dates

Study start
2019
Primary completion
2022
Study completion
2022
First posted
Jan 7, 2019
Registry last updated
May 5, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.