Memantine and Post-mastectomy Neuropathic Pain

NCT ID: NCT03686774

Last Updated: 2019-02-04

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE2
• Total Enrollment: 150 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-02-15
• Study Completion Date: 2022-01-31

Brief Summary

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.

Detailed 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.

Conditions

Neuropathic Pain

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Memantine group

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.

Group Type: EXPERIMENTAL

Memantine

Intervention Type: DRUG

Women provide written informed consent prior to their participation in the study, during their Anesthesiology visit. After baseline assessments (15 days before surgery: Day 0 - 15) of pain intensity, cognitive, quality of life and quality of sleep questionnaires, participants will be randomized in two parallel groups: "memantine" (n=75) or "usual care" (n=75). Memantine will be given orally for four weeks starting two weeks before surgery. Endpoints will be assessed 15 days (Day 0 + 15), 3 months (Day 0 + 3 months), 6 months (Day 0 + 6 months) et 12 months (Day 0 + 12 months) post-mastectomy. In order to maintain a good compliance and to verify that women do not develop adverse events, patients will be called once a week by phone. A booklet for monitoring will be completed daily by the patient for 3 months from the day of surgery.

Usual care group

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.

Group Type: OTHER

no memantine

Intervention Type: OTHER

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

Interventions

Memantine

Women provide written informed consent prior to their participation in the study, during their Anesthesiology visit. After baseline assessments (15 days before surgery: Day 0 - 15) of pain intensity, cognitive, quality of life and quality of sleep questionnaires, participants will be randomized in two parallel groups: "memantine" (n=75) or "usual care" (n=75). Memantine will be given orally for four weeks starting two weeks before surgery. Endpoints will be assessed 15 days (Day 0 + 15), 3 months (Day 0 + 3 months), 6 months (Day 0 + 6 months) et 12 months (Day 0 + 12 months) post-mastectomy. In order to maintain a good compliance and to verify that women do not develop adverse events, patients will be called once a week by phone. A booklet for monitoring will be completed daily by the patient for 3 months from the day of surgery.

Intervention Type: DRUG

no memantine

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

Intervention Type: OTHER

Eligibility Criteria

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...),

• Minimum Eligible Age: 18 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

University Hospital, Clermont-Ferrand

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Gisèle PICKERING

Role: PRINCIPAL_INVESTIGATOR

University Hospital, Clermont-Ferrand

Locations

Chu Clermont-Ferrand

Clermont-Ferrand, , France

Countries

France

Central Contacts

Lise LACLAUTRE

Role: CONTACT

drci@chu-clermontferrand.fr

04 73 75 49 63

Facility Contacts

Lise LACLAUTRE

Role: primary

drci@chu-clermontferrand.fr

04 73 75 49 63

Other Identifiers

2016-004930-75

Identifier Type: OTHER

Identifier Source: secondary_id

CHU-407

Identifier Type: -

Identifier Source: org_study_id