Cancer Related Fatigue, Quality of Life
Conditions
Keywords
Cancer related fatigue, Quality of life, Modafinil, Radiation therapy, Radiotherapy
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.
Interventions
DRUGModafinil
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
DRUGPyridoxine
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.
Sponsors
Indira Gandhi Medical College, Shimla
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
DOUBLE (Subject, Caregiver)
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Reduction in Cancer Related Fatigue | Baseline and 12 weeks | Changes in Fatigue measured with the Brief Fatigue Inventory (BFI). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Improvement in Quality of Life | Baseline and 12 weeks | The Spitzer Quality of Life Index (SQLI) to obtain Quality of Life (QOL) measurements. |
| Karnofsky Performance Status Scores | Baseline and 12 weeks | Performance status scores measured with the Karnofsky Performance Status (KPS) scale. |
| Effects of Modafinil on Systolic and Diastolic Blood Pressure | Baseline and 12 weeks | — |
| Changes in weight | Baseline and 12 weeks | — |
Countries
India
Outcome results
None listed