Overview

Modafinil in Cancer Related Fatigue

Status:
Completed
Trial end date:
2012-02-01
Target enrollment:
0
Participant gender:
All
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.
Phase:
Phase 3
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Indira Gandhi Medical College
Indira Gandhi Medical College, Shimla
Treatments:
Armodafinil
Modafinil
Pyridoxal
Pyridoxine
Vitamin B 6
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