Modafinil in Cancer Related Fatigue (ModCRF)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01440621
Recruitment Status : Completed
First Posted : September 26, 2011
Last Update Posted : March 23, 2012
Information provided by (Responsible Party):
Swaroop Revannasiddaiah, Indira Gandhi Medical College

September 20, 2011
September 26, 2011
March 23, 2012
August 2010
February 2012   (Final data collection date for primary outcome measure)
Reduction in Cancer Related Fatigue [ Time Frame: Baseline and 12 weeks ]
Changes in Fatigue measured with the Brief Fatigue Inventory (BFI).
Same as current
Complete list of historical versions of study NCT01440621 on Archive Site
  • 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 ]
Same as current
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Modafinil in Cancer Related Fatigue
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.

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Phase 3
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Care Provider)
Primary Purpose: Supportive Care
  • Cancer Related Fatigue
  • Quality of Life
  • Drug: Modafinil
    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
  • Drug: Pyridoxine
    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.
  • 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.
    Intervention: Drug: Modafinil
  • Placebo Comparator: Arm P
    Will be given placebo (Tab Pyridoxine 10mg) which physically resembles Tab Modafinil 100mg.
    Intervention: Drug: Pyridoxine

*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
February 2012
February 2012   (Final data collection date for primary outcome measure)

Inclusion Criteria:

  • Patients with pathological confirmation of cancer
  • Age 18 years to 70 years
  • Performance status (Karnofsky scale) not less than 60
  • Providing consent

Exclusion Criteria:

  • Psychiatric illness
  • Hypertension
  • Diabetes
  • Thyroid disorders
  • Epilepsy
  • Tuberculosis
Sexes Eligible for Study: All
18 Years to 70 Years   (Adult, Senior)
Contact information is only displayed when the study is recruiting subjects
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Swaroop Revannasiddaiah, Indira Gandhi Medical College
Indira Gandhi Medical College
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Indira Gandhi Medical College
March 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP