Modafinil in Cancer Related Fatigue (ModCRF)
|ClinicalTrials.gov Identifier: NCT01440621|
Recruitment Status : Completed
First Posted : September 26, 2011
Last Update Posted : March 23, 2012
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.
|Condition or disease||Intervention/treatment||Phase|
|Cancer Related Fatigue Quality of Life||Drug: Modafinil Drug: Pyridoxine||Phase 3|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||217 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Double (Participant, Care Provider)|
|Primary Purpose:||Supportive Care|
|Official Title:||Randomized Controlled Study to Evaluate the Effects of Modafinil in Cancer Related Fatigue in Patients Undergoing Radiation Therapy|
|Study Start Date :||August 2010|
|Primary Completion Date :||February 2012|
|Study Completion Date :||February 2012|
Active Comparator: 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.
Tablet Modafinil 100mg (Generic) to be given in 100mg once a day dose, at 8AM daily in the morning, and to be given from Day 1 of Radiation Therapy till the first post treatment follow-up
Placebo Comparator: Arm P
Will be given placebo (Tab Pyridoxine 10mg) which physically resembles Tab Modafinil 100mg.
Tablet Pyridoxine 10mg once a day at 8AM daily, from Day one of RT till first post-treatment followup. Tab Pyridoxine 10mg has been chosen as placebo as it resembles Tab Modafinil 100mg in physical appearance, size and shape. Tab Pyridoxine is unlikely to affect Cancer Related Fatigue on its own as all patients on RT are already on multivitamin supplements as per our institutional guidelines.
- Reduction in Cancer Related Fatigue [ Time Frame: Baseline and 12 weeks ]Changes in Fatigue measured with the Brief Fatigue Inventory (BFI).
- Improvement in Quality of Life [ Time Frame: Baseline and 12 weeks ]The Spitzer Quality of Life Index (SQLI) to obtain Quality of Life (QOL) measurements.
- Karnofsky Performance Status Scores [ Time Frame: Baseline and 12 weeks ]Performance status scores measured with the Karnofsky Performance Status (KPS) scale.
- Effects of Modafinil on Systolic and Diastolic Blood Pressure [ Time Frame: Baseline and 12 weeks ]
- Changes in weight [ Time Frame: Baseline and 12 weeks ]
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01440621
|Regional Cancer Centre|
|Shimla, Himachal Pradesh, India, 171001|