NCT00917748已完成3 期
A Prospective, Randomised, Double-Blind, Placebo-Controlled Phase III Study of Modafinil to Improve Fatigue and Quality of Life in Patients Treated With Docetaxel-Based Chemotherapy for Metastatic Breast or Prostate Cancer
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- Sanofi
- 入组人数
- 84
- 试验地点
- 1
- 主要终点
- Fatigue scores daily assessed using the 11-point (0-10) 0 is the lower score and 10 is the highest. this score is calculated using the MD Anderson Symptom Inventory
研究概览
简要总结
The primary objective is:
- To determine the efficacy of modafinil in the reduction of fatigue in patients with metastatic breast or prostate cancer undergoing docetaxel-based chemotherapy
The secondary objectives are:
- To determine the effect of modafinil on quality of life (QoL) during docetaxel-based chemotherapy
- To determine the effect of modafinil on patients physical activity level, functional status, number of chemotherapy cycles tolerated, sleep disturbance and depression, during docetaxel-based chemotherapy
- To investigate the impact of tumour type, patient physical activity level, functional status, sleep disturbance and depression on the efficacy of modafinil at improving fatigue and quality of life during docetaxel-based chemotherapy.
- To determine the safety and tolerability of modafinil during docetaxel-based chemotherapy
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- 未提供
研究组 & 干预措施
1
Experimental
docetaxel chemotherapy + modafinil 100 mg capsules
干预措施: DOCETAXEL(XRP6976) + MODAFINIL (Drug)
1
Experimental
docetaxel chemotherapy + modafinil 100 mg capsules
干预措施: Modafinil (Drug)
2
Placebo Comparator
docetaxel chemotherapy + placebo (lactose) capsules (matched to modafinil drug)
干预措施: DOCETAXEL(XRP6976) + MODAFINIL (Drug)
2
Placebo Comparator
docetaxel chemotherapy + placebo (lactose) capsules (matched to modafinil drug)
干预措施: Placebo of Modafinil (Drug)
结局指标
主要结局
Fatigue scores daily assessed using the 11-point (0-10) 0 is the lower score and 10 is the highest. this score is calculated using the MD Anderson Symptom Inventory
时间窗: From baseline to the end of study (week 12)
次要结局
- Patient quality of life weekly assessed by using the self-administered Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-F) Quality Of Life survey(From baseline to the end of study (week 12))
- Fatigue assessed by using the self-administered six-item somatic subscale (SOMA) of the Somatic and Psychological Health Report (SPHERE) questionnaire(At screening and from visit 6 (week 3) of treatment to end of study (week 12))
- Sleep quality assessed by using the self-administered Pittsburgh Sleep Quality Index (PSQI) questionnaire(At baseline and from visit 6 (week 3) to end of study (week 12))
- Functional status will be determined using the self-administered Medical Outcomes Study - Short Form Health Survey (SF-36)(At baseline and from visit 6 (week 3) to end of study (week 12))
- Depression assessed using seven depression-related questions from the self-administered Hospital Anxiety and Depression (HAD) assessment subscale. Patient with depression will be defined as having the HAD-D> or = 8(At baseline and last visit= end of study (week 12))
研究者
研究点 (1)
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