Memantine and Post-mastectomy Neuropathic Pain

NCT03686774 | Unknown Phase 2

• 2 other identifiers: CHU-4072016-004930-75
• Study Type: interventional
• Target: 150
• Locations: 1 country
• Sites: 1

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.

Conditions

Neuropathic Pain

Keywords

Memantine; post-mastectomy; prophylaxis; Neuropathic pain; Cognitive-emotional parameters

Outcome Measures

Primary Outcomes (1)

• Numerical pain rating scale (NPRS)

  The primary endpoint is the measure of the average pain intensity assessed over the 5 days prior to the 3-month post-surgery visit by NPRS, in the "memantine" and "usual care" groups. This scale ranges from 0 no pain to 10 maximal tolerable pain.

  over the 5 days prior to the 3-month post-surgery visit

Secondary Outcomes (11)

• Analgesic consumption

  Over 12 months

• Neuropathic pain characteristics

  At baseline (15 days before surgery: Day 0 - 15 days), visit 3 (Day 0 + 16 days), visit 4 (Day 0 + 3 months), visit 5 (Day 0 + 6 months) and visit 6 (Day 0 + 12 months).

• Neuropathic pain evaluation by Neuropathic pain symptom Inventory (NPSI) questionnaire.

  At baseline (15 days before surgery: Day 0 - 15 days), visit 3 (Day 0 + 16 days), visit 4 (Day 0 + 3 months), visit 5 (Day 0 + 6 months) and visit 6 (Day 0 + 12 months).

• Pain evaluation by the Brief Pain Inventory (BPI).

  At baseline (15 days before surgery: Day 0 - 15 days), visit 3 (Day 0 + 16 days), visit 4 (Day 0 + 3 months), visit 5 (Day 0 + 6 months) and visit 6 (Day 0 + 12 months).

• Pain evaluation by the McGill Pain questionnaire

  At baseline (15 days before surgery: Day 0 - 15 days), visit 3 (Day 0 + 16 days), visit 4 (Day 0 + 3 months), visit 5 (Day 0 + 6 months) and visit 6 (Day 0 + 12 months).

Study Arms (2)

Memantine group

EXPERIMENTAL

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.

Drug: Memantine

Usual care group

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.

Other: no memantine

Interventions

Memantine 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.

Memantine group

no memantine 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

Usual care group

Eligibility Criteria

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

You may qualify if:

• 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.

You may not qualify if:

• 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 benefiting from a legal protection measure (curatorship, guardianship, protection of justice...),

Sponsors & Collaborators

• University Hospital, Clermont-Ferrand: lead

Study Sites (1)

Chu Clermont-Ferrand

Clermont-Ferrand, 63003, France

Location

MeSH Terms

Conditions

Neuralgia

Interventions

Memantine

Condition Hierarchy (Ancestors)

Peripheral Nervous System Diseases; Neuromuscular Diseases; Nervous System Diseases; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Amantadine; Adamantane; Bridged-Ring Compounds; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals

Study Officials

• Gisèle PICKERING

  University Hospital, Clermont-Ferrand

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Lise LACLAUTRE

CONTACT

04 73 75 49 63; drci@chu-clermontferrand.fr

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: no masking
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 18, 2018
• First Posted: September 27, 2018
• Study Start: February 15, 2019
• Primary Completion: January 31, 2022
• Study Completion: January 31, 2022
• Last Updated: February 4, 2019

Record last verified: 2019-02

Locations

FR (1)