Randomized Controlled Study to Evaluate the Effects of Modafinil in Cancer Related Fatigue in Patients Undergoing Radiation Therapy
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 217
- 试验地点
- 1
- 主要终点
- Reduction in Cancer Related Fatigue
研究概览
简要总结
Cancer related fatigue (CRF) is a highly prevalent and highly significant entity among patients with cancer. 'Cancer related fatigue' is not a simple symptom, but is an entity in itself, in that it is different from routine fatigue. Cancer related fatigue is that fatigue which persists even after rest and has significant effects on quality of life.
The incidence of Cancer Related Fatigue (CRF) increases during radiation therapy (RT), with almost every patient on radiotherapy complaining of at-least some magnitude of fatigue.
Given that fatigue can affect treatment adherence by patients, it is important to initiate measures to either prevent or mitigate Cancer Related Fatigue.
The investigators intend to use modafinil in cancer related fatigue, in view of the fact that it has safety and efficacy in other diseases such as narcolepsy, multiple sclerosis and fibromyalgia. In addition, there have been a few small trials which have hinted towards benefit with the use of modafinil in cancer related fatigue.
The investigators have chosen a dose of 100mg/day in the morning, to be compared with placebo. The study arm and the placebo arm will be stratified with respect to age, sex, disease site, baseline performance status.
Primary outcome would be fatigue, which will be assessed by the use of Brief Fatigue Inventory (BFI). Secondary outcomes include Quality of Life, improvements in performance status, changes in systolic and diastolic blood pressure, and changes in weight.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Double (Participant, Care Provider)
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with pathological confirmation of cancer
- •Age 18 years to 70 years
- •Performance status (Karnofsky scale) not less than 60
- •Providing consent
排除标准
- •Psychiatric illness
- •Hypertension
- •Thyroid disorders
- •Tuberculosis
研究组 & 干预措施
Arm M
Will be treated with Tab Modafinil (generic) 100mg Once a Day in the Morning starting from Day 1 of RT till the first follow-up.
干预措施: Modafinil (Drug)
Arm P
Will be given placebo (Tab Pyridoxine 10mg) which physically resembles Tab Modafinil 100mg.
干预措施: Pyridoxine (Drug)
结局指标
主要结局
Reduction in Cancer Related Fatigue
时间窗: Baseline and 12 weeks
Changes in Fatigue measured with the Brief Fatigue Inventory (BFI).
次要结局
- Improvement in Quality of Life(Baseline and 12 weeks)
- Karnofsky Performance Status Scores(Baseline and 12 weeks)
- Effects of Modafinil on Systolic and Diastolic Blood Pressure(Baseline and 12 weeks)
- Changes in weight(Baseline and 12 weeks)
研究者
Swaroop Revannasiddaiah
Post-Graduate in Radiation Oncology
Indira Gandhi Medical College, Shimla