Memantine and Post-mastectomy Neuropathic Pain (CLEMANTINE)

University Hospital, Clermont-Ferrand

Status and phase: Unknown; Phase 2

Conditions: Neuropathic Pain

Treatments: Other: no memantine; Drug: Memantine

Study type: Interventional

Funder types: Other

Identifiers

NCT03686774

CHU-407

2016-004930-75 (Other Identifier)

Details and patient eligibility

About

The aim of this study is to evaluate if memantine administered for four weeks starting two weeks before surgery induces a decrease in pain intensity at 3 months post-mastectomy.

Full description

This is a randomized, controlled, open-label study in patients undergoing mastectomy. Patients included in this trial will receive memantine or not. For patients in the "memantine" group, the treatment will be given in titration (maximum dose of 20 mg/day). Concerning the comparator group, patients will be followed in the same way as those in the "memantine" group except that they will not receive the study treatment. Whether it is the "memantine" group or the "usual care" group, visits will be scheduled under the usual following conditions of the participating center.

Enrollment: 150 estimated patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Patient ≥18 years,
• Patient with a diagnosis of breast cancer, programmed for mastectomy with or without axillary dissection and neoadjuvant chemotherapy,
• Patient able to understand and willing to follow the study protocol,
• Acceptance to give a written consent.

Exclusion criteria

• Patient with a contraindication to memantine administration (hypertension, severe cardiac or hepatic insufficiency, stroke),
• Patient with diabetes (type I and II),
• Patient with renal insufficiency,
• Patient with drug treatments evaluated by the investigator to be not compatible with the trial,
• Patient treated with specific drugs (amantadine, ketamine, dextromethorphan, L-Dopa, dopaminergic, anticholinergic agonists, barbituric, neuroleptic, IMAO, antispastic agents, dantrolen or baclofen, phenytoin, cimetidine, ranitidine, procainamide, quinidine, quinine, nicotine, hydrochlorothiazide, warfarine),
• Patient with alcohol addiction,
• Epileptic patient or history of epileptic seizure or convulsions,
• Pregnant or nursing woman,
• Patient with a cooperation and an understanding that does not allow for a strict compliance under the conditions set out in the protocol,
• Patient participating in another clinical trial, or being in an exclusion period, or having received a total amount of compensation exceeding 4500 euros over the 12 months preceding the start of the trial,
• Patient benefiting from a legal protection measure (curatorship, guardianship, protection of justice...),

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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150 participants in 2 patient groups

Memantine group

Experimental group

Description:

Memantine will be given orally for four weeks starting two weeks before surgery. Memantine will be given in increasing doses: 5 mg/day for 3 days; 10 mg/day for 3 days; 15 mg/day for 3 days and 20 mg/day for 5 days.

Treatment:

Drug: Memantine

Usual care group

Other group

Description:

Concerning the comparator group, patients will be followed in the same way as those in the "memantine" group except that they will not receive the study treatment.

Treatment:

Other: no memantine