ModCRF: Modafinil in Cancer Related Fatigue

Sponsor

Indira Gandhi Medical College, Shimla (Other)

Overall Status

Completed

CT.gov ID

NCT01440621

Collaborator

(none)

217

Enrollment

Location

Arms

Duration (Months)

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Cancer Related Fatigue Quality of Life	Drug: Modafinil Drug: Pyridoxine	Phase 3

Study Design

Study Type:

Interventional

Actual Enrollment :

217 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Double (Participant, Care Provider)

Primary Purpose:

Supportive Care

Official Title:

Randomized Controlled Study to Evaluate the Effects of Modafinil in Cancer Related Fatigue in Patients Undergoing Radiation Therapy

Study Start Date :

Aug 1, 2010

Actual Primary Completion Date :

Feb 1, 2012

Actual Study Completion Date :

Feb 1, 2012

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: Arm M 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.	Drug: Modafinil 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
Placebo Comparator: Arm P Will be given placebo (Tab Pyridoxine 10mg) which physically resembles Tab Modafinil 100mg.	Drug: Pyridoxine 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.

Arm

Intervention/Treatment

Active Comparator: Arm M

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.

Drug: Modafinil

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

Placebo Comparator: Arm P

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

Drug: Pyridoxine

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.

Outcome Measures

Primary Outcome Measures

Reduction in Cancer Related Fatigue [Baseline and 12 weeks]
Changes in Fatigue measured with the Brief Fatigue Inventory (BFI).

Secondary Outcome Measures

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]