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Modafinil in Cancer Related Fatigue (ModCRF)

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01440621
First Posted: September 26, 2011
Last Update Posted: March 23, 2012
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.
Information provided by (Responsible Party):
Swaroop Revannasiddaiah, Indira Gandhi Medical College
  Purpose

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 Intervention Phase
Cancer Related Fatigue Quality of Life Drug: Modafinil Drug: Pyridoxine Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
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

Resource links provided by NLM:


Further study details as provided by Swaroop Revannasiddaiah, Indira Gandhi Medical College:

Primary Outcome Measures:
  • Reduction in Cancer Related Fatigue [ Time Frame: Baseline and 12 weeks ]
    Changes in Fatigue measured with the Brief Fatigue Inventory (BFI).


Secondary Outcome Measures:
  • 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 ]

Enrollment: 217
Study Start Date: August 2010
Study Completion Date: February 2012
Primary Completion Date: February 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.
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
Placebo Comparator: Arm P
Will be given placebo (Tab Pyridoxine 10mg) which physically resembles Tab Modafinil 100mg.
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.

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01440621


Locations
India
Regional Cancer Centre
Shimla, Himachal Pradesh, India, 171001
Sponsors and Collaborators
Indira Gandhi Medical College
  More Information

Additional Information:
Publications:
Responsible Party: Swaroop Revannasiddaiah, Post-Graduate in Radiation Oncology, Indira Gandhi Medical College
ClinicalTrials.gov Identifier: NCT01440621     History of Changes
Other Study ID Numbers: ModCRF
First Submitted: September 20, 2011
First Posted: September 26, 2011
Last Update Posted: March 23, 2012
Last Verified: March 2012

Keywords provided by Swaroop Revannasiddaiah, Indira Gandhi Medical College:
Cancer related fatigue
Quality of life
Modafinil
Radiation therapy
Radiotherapy

Additional relevant MeSH terms:
Fatigue
Signs and Symptoms
Modafinil
Armodafinil
Pyridoxine
Pyridoxal
Vitamin B 6
Wakefulness-Promoting Agents
Central Nervous System Stimulants
Cytochrome P-450 CYP3A Inducers
Cytochrome P-450 Enzyme Inducers
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Vitamin B Complex
Vitamins
Micronutrients
Growth Substances