Effect of Oral Administration of Memantine in Pre and Post-surgery in the Prevention of Post-mastectomy Neuropathic Pain
试验速览
- 阶段
- 2 期
- 发起方
- 入组人数
- 150
- 试验地点
- 1
- 主要终点
- Numerical pain rating scale (NPRS)
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
盲法说明
no masking
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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...),
研究组 & 干预措施
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.
干预措施: Memantine (Drug)
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.
干预措施: no memantine (Other)
结局指标
主要结局
Numerical pain rating scale (NPRS)
时间窗: over the 5 days prior to the 3-month post-surgery visit
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.
次要结局
- 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).)
- Assessment of cognitive parameters by the trail making test (TMT).(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).)
- Assessment of cognitive parameters by the Digit symbol substitution test (DSST).(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).)
- Assessment of cognitive parameters with the Functional Assessment of Cancer Therapy Cognitive Function (FACT-COG).(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).)
- Quality of life assessment by the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 items (EORTC QLQ-C30).(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).)
- Anxiety and depression assessment with the Hospital Anxiety and Depression scale (HAD).(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).)
- Sleep assessment with the Pittsburgh Sleep Quality Index (PSQI)(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).)