Clinical trial NCT03686774: Memantine and Post-mastectomy Neuropathic Pain
Official title: Effect of Oral Administration of Memantine in Pre and Post-surgery in the Prevention of Post-mastectomy Neuropathic Pain
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Neuropathic Pain
Keywords: Memantine
post-mastectomy
prophylaxis
Neuropathic pain
Cognitive-emotional parameters
Lead sponsor: University Hospital, Clermont-Ferrand
Sponsor class: OTHER
First posted: 2018-09-27
Enrollment: 150
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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...),

Primary outcomes:
measure: Numerical pain rating scale (NPRS)
timeFrame: over the 5 days prior to the 3-month post-surgery visit
Secondary outcomes:
measure: Analgesic consumption
timeFrame: Over 12 months
measure: Neuropathic pain characteristics
timeFrame: 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).
measure: Neuropathic pain evaluation by Neuropathic pain symptom Inventory (NPSI) questionnaire.
timeFrame: 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).
measure: Pain evaluation by the Brief Pain Inventory (BPI).
timeFrame: 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).
measure: Pain evaluation by the McGill Pain questionnaire
timeFrame: 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).
measure: Assessment of cognitive parameters by the trail making test (TMT).
timeFrame: 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).
measure: Assessment of cognitive parameters by the Digit symbol substitution test (DSST).
timeFrame: 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).
measure: Assessment of cognitive parameters with the Functional Assessment of Cancer Therapy Cognitive Function (FACT-COG).
timeFrame: 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).
measure: Quality of life assessment by the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 items (EORTC QLQ-C30).
timeFrame: 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).
measure: Anxiety and depression assessment with the Hospital Anxiety and Depression scale (HAD).
timeFrame: 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).
measure: Sleep assessment with the Pittsburgh Sleep Quality Index (PSQI)
timeFrame: 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).
Other outcomes:
Locations:
city: Clermont-Ferrand
country: France
facility: Chu Clermont-Ferrand
Study officials:
affiliation: University Hospital, Clermont-Ferrand
name: Gisèle PICKERING
role: PRINCIPAL_INVESTIGATOR
References: