Modafinil in Cancer Related Fatigue (ModCRF)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Swaroop Revannasiddaiah, Indira Gandhi Medical College
ClinicalTrials.gov Identifier:
NCT01440621
First received: September 20, 2011
Last updated: March 21, 2012
Last verified: March 2012

September 20, 2011
March 21, 2012
August 2010
February 2012   (final data collection date for primary outcome measure)
Reduction in Cancer Related Fatigue [ Time Frame: Baseline and 12 weeks ] [ Designated as safety issue: No ]
Changes in Fatigue measured with the Brief Fatigue Inventory (BFI).
Same as current
Complete list of historical versions of study NCT01440621 on ClinicalTrials.gov Archive Site
  • Improvement in Quality of Life [ Time Frame: Baseline and 12 weeks ] [ Designated as safety issue: No ]
    The Spitzer Quality of Life Index (SQLI) to obtain Quality of Life (QOL) measurements.
  • Karnofsky Performance Status Scores [ Time Frame: Baseline and 12 weeks ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: Yes ]
  • Changes in weight [ Time Frame: Baseline and 12 weeks ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
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.

Not Provided
Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver)
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 ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
217
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
Both
18 Years to 70 Years
No
Contact information is only displayed when the study is recruiting subjects
India
 
NCT01440621
ModCRF
Not Provided
Swaroop Revannasiddaiah, Indira Gandhi Medical College
Indira Gandhi Medical College
Not Provided
Not Provided
Indira Gandhi Medical College
March 2012

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