Quality of Life Clinical Trial
Official title:
Randomized Controlled Study to Evaluate the Effects of Modafinil in Cancer Related Fatigue in Patients Undergoing Radiation Therapy
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.
n/a
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver), Primary Purpose: Supportive Care
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