Modafinil in Cancer Related Fatigue

Phase 3

Completed

• Conditions: Cancer Related Fatigue; Quality of Life
• Interventions: Drug: Modafinil; Drug: Pyridoxine

• Registration Number: NCT01440621
• Lead Sponsor: Indira Gandhi Medical College, Shimla

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2010-08
• Study First Submitted: 2011-09-20
• Study First Submitted QC: 2011-09-22
• Study First Posted: 2011-09-26
• Primary Completion: 2012-02
• Study Completion: 2012-02
• Status Verified: 2012-03
• Last Update Submitted: 2012-03-21
• Last Update Posted: 2012-03-23

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 217

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Arm M	Modafinil	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.
Arm P	Pyridoxine	Will be given placebo (Tab Pyridoxine 10mg) which physically resembles Tab Modafinil 100mg.

Primary Outcome Measures

Name	Time	Method
Reduction in Cancer Related Fatigue	Baseline and 12 weeks	Changes in Fatigue measured with the Brief Fatigue Inventory (BFI).

Secondary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

Regional Cancer Centre; 🇮🇳 Shimla, Himachal Pradesh, India