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NCT01440621 Clinical Trial

Modafinil in Cancer Related Fatigue

Quality of Life Clinical Trial

— ModCRF  

Official title:
Randomized Controlled Study to Evaluate the Effects of Modafinil in Cancer Related Fatigue in Patients Undergoing Radiation Therapy

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT01440621
Other study ID # ModCRF
Secondary ID
Status Completed
Phase Phase 3
First received September 20, 2011
Last updated March 21, 2012
Start date August 2010
Est. completion date February 2012

Study information
Verified date March 2012
Source Indira Gandhi Medical College
Contact n/a
Is FDA regulated No
Health authority India: Indian Council of Medical Research
Study type Interventional

Clinical Trial 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.

Recruitment information / eligibility
Status Completed
Enrollment 217
Est. completion date February 2012
Est. primary completion date February 2012
Accepts healthy volunteers No
Gender Both
Age group 18 Years to 70 Years
Eligibility 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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver), Primary Purpose: Supportive Care

Related Conditions & MeSH terms

Intervention

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
• 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.

Locations
Country Name City State
India Regional Cancer Centre Shimla Himachal Pradesh

Sponsors (1)
Lead Sponsor Collaborator
Indira Gandhi Medical College

Country where clinical trial is conducted

India, 

References & Publications (5)

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. doi: 10.1089/jpm.2008.0230. — View Citation

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. doi: 10.1345/aph.1L532. Epub 2009 Mar 24. Review. — View Citation

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 pati — View Citation

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. doi: 10.1177/0269216309102614. Epub 2009 Mar 6. — View Citation

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. doi: 10.1007/s00482-010-0987-y. German. — View Citation

Outcome
Type Measure Description Time frame Safety issue
Primary Reduction in Cancer Related Fatigue Changes in Fatigue measured with the Brief Fatigue Inventory (BFI). Baseline and 12 weeks No
Secondary Improvement in Quality of Life The Spitzer Quality of Life Index (SQLI) to obtain Quality of Life (QOL) measurements. Baseline and 12 weeks No
Secondary Karnofsky Performance Status Scores Performance status scores measured with the Karnofsky Performance Status (KPS) scale. Baseline and 12 weeks No
Secondary Effects of Modafinil on Systolic and Diastolic Blood Pressure Baseline and 12 weeks Yes
Secondary Changes in weight Baseline and 12 weeks No
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