Modafinil in Cancer Related Fatigue (ModCRF)
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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 Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver) Primary Purpose: Supportive Care |
| Official Title: | Randomized Controlled Study to Evaluate the Effects of Modafinil in Cancer Related Fatigue in Patients Undergoing Radiation Therapy |
- 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).
- 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 ]
| 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| Ages Eligible for Study: | 18 Years to 70 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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 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 |
| Study First Received: | September 20, 2011 |
| Last Updated: | March 21, 2012 |
| Health Authority: | India: Indian Council of Medical Research |
Keywords provided by Indira Gandhi Medical College:
|
Cancer related fatigue Quality of life Modafinil Radiation therapy Radiotherapy |
Additional relevant MeSH terms:
|
Fatigue Signs and Symptoms Pyridoxine Vitamin B 6 Pyridoxal Modafinil Vitamin B Complex Vitamins Micronutrients |
Growth Substances Physiological Effects of Drugs Pharmacologic Actions Central Nervous System Stimulants Central Nervous System Agents Therapeutic Uses Neuroprotective Agents Protective Agents |
ClinicalTrials.gov processed this record on May 16, 2013