Modafinil in Cancer Related Fatigue (ModCRF)

Indira Gandhi Medical College, Shimla

Status and phase: Completed; Phase 3

Conditions: Cancer Related Fatigue; Quality of Life

Treatments: Drug: Pyridoxine; Drug: Modafinil

Study type: Interventional

Funder types: Other

Identifiers

NCT01440621

ModCRF

Details and patient eligibility

About

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.

Enrollment: 217 patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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217 participants in 2 patient groups, including a placebo group

Arm M

Active Comparator group

Description:

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.

Treatment:

Drug: Modafinil

Arm P

Placebo Comparator group

Description:

Will be given placebo (Tab Pyridoxine 10mg) which physically resembles Tab Modafinil 100mg.

Treatment:

Drug: Pyridoxine