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

History of Changes

Tracking Information
First Received Date ^ICMJE	September 20, 2011
Last Updated Date	March 21, 2012
Start Date ^ICMJE	August 2010
Primary Completion Date	February 2012 (final data collection date for primary outcome measure)
Current Primary Outcome Measures ^ICMJE (submitted: September 22, 2011)	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).
Original Primary Outcome Measures ^ICMJE	Same as current
Change History	Complete list of historical versions of study NCT01440621 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ^ICMJE (submitted: September 22, 2011)	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 ]
Original Secondary Outcome Measures ^ICMJE	Same as current
Current Other Outcome Measures ^ICMJE	Not Provided
Original Other Outcome Measures ^ICMJE	Not Provided

Descriptive Information
Brief Title ^ICMJE	Modafinil in Cancer Related Fatigue
Official Title ^ICMJE	Randomized Controlled Study to Evaluate the Effects of Modafinil in Cancer Related Fatigue in Patients Undergoing Radiation Therapy
Brief Summary	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.
Detailed Description	Not Provided
Study Type ^ICMJE	Interventional
Study Phase	Phase 3
Study Design ^ICMJE	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver) Primary Purpose: Supportive Care
Condition ^ICMJE	Cancer Related Fatigue Quality of Life
Intervention ^ICMJE	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.
Study Arm (s)	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
Publications *	Spathis A, Dhillan R, Booden D, Forbes K, Vrotsou K, Fife K. Modafinil for the treatment of fatigue in lung cancer: a pilot study. Palliat Med. 2009 Jun;23(4):325-31. Epub 2009 Mar 6. Cooper MR, Bird HM, Steinberg M. Efficacy and safety of modafinil in the treatment of cancer-related fatigue. Ann Pharmacother. 2009 Apr;43(4):721-5. Epub 2009 Mar 24. Review. Blackhall L, Petroni G, Shu J, Baum L, Farace E. A pilot study evaluating the safety and efficacy of modafinal for cancer-related fatigue. J Palliat Med. 2009 May;12(5):433-9. Wirz S, Nadstawek J, Kühn KU, Vater S, Junker U, Wartenberg HC. [Modafinil for the treatment of cancer-related fatigue : an intervention study]. Schmerz. 2010 Dec;24(6):587-95. German. Jean-Pierre P, Morrow GR, Roscoe JA, Heckler C, Mohile S, Janelsins M, Peppone L, Hemstad A, Esparaz BT, Hopkins JO. A phase 3 randomized, placebo-controlled, double-blind, clinical trial of the effect of modafinil on cancer-related fatigue among 631 patients receiving chemotherapy: a University of Rochester Cancer Center Community Clinical Oncology Program Research base study. Cancer. 2010 Jul 15;116(14):3513-20.
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information
Recruitment Status ^ICMJE	Completed
Enrollment ^ICMJE	217
Completion Date	February 2012
Primary Completion Date	February 2012 (final data collection date for primary outcome measure)
Eligibility Criteria ^ICMJE	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
Gender	Both
Ages	18 Years to 70 Years
Accepts Healthy Volunteers	No
Contacts ^ICMJE	Contact information is only displayed when the study is recruiting subjects
Location Countries ^ICMJE	India

Administrative Information
NCT Number ^ICMJE	NCT01440621
Other Study ID Numbers ^ICMJE	ModCRF
Has Data Monitoring Committee	Not Provided
Responsible Party	Swaroop Revannasiddaiah, Indira Gandhi Medical College
Study Sponsor ^ICMJE	Indira Gandhi Medical College
Collaborators ^ICMJE	Not Provided
Investigators ^ICMJE	Not Provided
Information Provided By	Indira Gandhi Medical College
Verification Date	March 2012
^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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