Modafinil in Cancer Related Fatigue

Study Overview
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Brief Summary
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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.

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

Conditions
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Cancer Related Fatigue, Quality of Life

Intervention / Treatment
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* Drug: Modafinil
* Drug: Pyridoxine


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Arm M<br>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<br>* 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<br>|
| Placebo Comparator: Arm P<br>Will be given placebo (Tab Pyridoxine 10mg) which physically resembles Tab Modafinil 100mg. | Drug: Pyridoxine<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Reduction in Cancer Related Fatigue | Changes in Fatigue measured with the Brief Fatigue Inventory (BFI). | Baseline and 12 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Improvement in Quality of Life | The Spitzer Quality of Life Index (SQLI) to obtain Quality of Life (QOL) measurements. | Baseline and 12 weeks | 
| Karnofsky Performance Status Scores | Performance status scores measured with the Karnofsky Performance Status (KPS) scale. | Baseline and 12 weeks | 
| Effects of Modafinil on Systolic and Diastolic Blood Pressure |  | Baseline and 12 weeks | 
| Changes in weight |  | Baseline and 12 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Cancer related fatigue, Quality of life, Modafinil, Radiation therapy, Radiotherapy