Evaluation in the Treatment of Neuropathic Pain Post Breast Surgery

NCT03794388 | Completed Phase 3 Results DMC

• 1 other identifier: ICO-A-2018-10
• Study Type: interventional
• Target: 140
• Locations: 1 country
• Sites: 11

Brief 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. 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.

Conditions

Breast Cancer Patient

Keywords

Breast cancer patient; Surgery; Inter Costobrachial Neuralgia

Outcome Measures

Primary Outcomes (1)

• 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

  2 months

Secondary Outcomes (1)

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

  6 months

Study Arms (2)

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.

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.

Drug: Pregabalin

Interventions

Capsaicin DRUG

Application of capsaicin patches at 8% on painful area

Also known as: qutenza EU/1/09/524/001

Arm CAPSAICINE topical

Pregabalin DRUG

Taking Pregabalin tablets

Also known as: Lyrica

Arm PREGABALINE

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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
• Obtaining the signed written consent of the patient
• Major patient affiliated to a social security scheme

You may not qualify if:

• Contraindications specific to the treatments studied : capsaicine and pregabalin
• Diabetic patient
• Previous treatment with capsaicin or pregabalin
• 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

Sponsors & Collaborators

• Institut Cancerologie de l'Ouest: lead
• Grünenthal GmbH: collaborator

Study Sites (11)

Institut de Cancerologie de L'Ouest

Angers, 49000, France

Location

Chu Grenoble

Grenoble, 38700, France

Location

Chd Vendee

La Roche-sur-Yon, 85025, France

Location

Centre Oscar Lambret

Lille, 59020, France

Location

Hopital Saint Vincent de Paul

Lille, 59020, France

Location

Centre Leon Berard

Lyon, 69008, France

Location

CHU NICE

Nice, 06003, France

Location

Institut Jean Godinot

Reims, 51100, France

Location

Institut Curie

Saint-Cloud, 92210, France

Location

Iuct Oncopole

Toulouse, 31052, France

Location

Ch Valenciennes

Valenciennes, 53322, France

Location

MeSH Terms

Interventions

Capsaicin; Pregabalin

Intervention Hierarchy (Ancestors)

Polyunsaturated Alkamides; Amides; Organic Chemicals; Alkenes; Hydrocarbons, Acyclic; Hydrocarbons; Catechols; Phenols; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Solanaceous Alkaloids; Alkaloids; Heterocyclic Compounds; Fatty Acids, Monounsaturated; Fatty Acids, Unsaturated; Fatty Acids; Lipids; gamma-Aminobutyric Acid; Aminobutyrates; Butyrates; Acids, Acyclic; Carboxylic Acids; Amino Acids; Amino Acids, Peptides, and Proteins

Results Point of Contact

• Title: Dr DENIS DUPOIRON
• Organization: INSTITUT DE CANCEROLOGIE DE L'OUEST

Denis.Dupoiron@ico.unicancer.fr

02 41 35 27 00

Study Officials

• DENIS DUPOIRON, MD

  Institut de Cancérologie de l'Ouest

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Multicenter, open, randomized study

Study Record Dates

• First Submitted: November 5, 2018
• First Posted: January 7, 2019
• Study Start: March 19, 2019
• Primary Completion: November 18, 2022
• Study Completion: November 18, 2022
• Last Updated: May 5, 2026
• Results First Posted: May 5, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

FR (11)