Randomized Controlled Study to Evaluate the Effects of Modafinil in Cancer Related Fatigue in Patients Undergoing Radiation Therapy
Phase 3
18 Years
70 Years
18 Years
70 Years
Not Enrolling
Both
Cancer Related Fatigue, Quality of Life
Both
Cancer Related Fatigue, Quality of Life
Trial Information
Randomized Controlled Study to Evaluate the Effects of Modafinil in Cancer Related Fatigue in Patients Undergoing Radiation Therapy
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
Type of Study:
Interventional
Study Design:
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver), Primary Purpose: Supportive Care
Outcome Measure:
Reduction in Cancer Related Fatigue
Outcome Description:
Changes in Fatigue measured with the Brief Fatigue Inventory (BFI).
Outcome Time Frame:
Baseline and 12 weeks
Safety Issue:
No
Authority:
India: Indian Council of Medical Research
Study ID:
ModCRF
NCT ID:
NCT01440621
Start Date:
August 2010
Completion Date:
February 2012
Related Keywords:
- Cancer Related Fatigue
- Quality of Life
- Cancer related fatigue
- Quality of life
- Modafinil
- Radiation therapy
- Radiotherapy
- Fatigue
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