Clinical trial NCT01440621: Modafinil in Cancer Related Fatigue
Official title: Randomized Controlled Study to Evaluate the Effects of Modafinil in Cancer Related Fatigue in Patients Undergoing Radiation Therapy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Cancer Related Fatigue
Quality of Life
Keywords: Cancer related fatigue
Quality of life
Modafinil
Radiation therapy
Radiotherapy
Lead sponsor: Indira Gandhi Medical College, Shimla
Sponsor class: OTHER
First posted: 2011-09-26
Enrollment: 217
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.


Eligibility 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

Primary outcomes:
measure: Reduction in Cancer Related Fatigue
timeFrame: Baseline and 12 weeks
Secondary outcomes:
measure: Improvement in Quality of Life
timeFrame: Baseline and 12 weeks
measure: Karnofsky Performance Status Scores
timeFrame: Baseline and 12 weeks
measure: Effects of Modafinil on Systolic and Diastolic Blood Pressure
timeFrame: Baseline and 12 weeks
measure: Changes in weight
timeFrame: Baseline and 12 weeks
Other outcomes:
Locations:
city: Shimla
country: India
facility: Regional Cancer Centre
state: Himachal Pradesh
Study officials:
References:
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.
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.
citation: 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.
citation: Wirz S, Nadstawek J, Kuhn 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.
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 patients receiving chemotherapy: a University of Rochester Cancer Center Community Clinical Oncology Program Research base study. Cancer. 2010 Jul 15;116(14):3513-20. doi: 10.1002/cncr.25083.