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NCT Number: NCT01440621

Modafinil in Cancer Related Fatigue

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.

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Key information

Conditions

Cancer Related Fatigue Quality of Life

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Regional Cancer Centre

Shimla, Himachal Pradesh, 171001, India

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Modafinil

Drug

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

Pyridoxine

Drug

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.

Primary outcomes

  1. Reduction in Cancer Related Fatigue

    Time frame: Baseline and 12 weeks

    Changes in Fatigue measured with the Brief Fatigue Inventory (BFI).

Secondary outcomes

  1. Improvement in Quality of Life

    Time frame: Baseline and 12 weeks

    The Spitzer Quality of Life Index (SQLI) to obtain Quality of Life (QOL) measurements.

  2. Karnofsky Performance Status Scores

    Time frame: Baseline and 12 weeks

    Performance status scores measured with the Karnofsky Performance Status (KPS) scale.

  3. Effects of Modafinil on Systolic and Diastolic Blood Pressure

    Time frame: Baseline and 12 weeks

  4. Changes in weight

    Time frame: Baseline and 12 weeks

Sponsors and collaborators

Lead sponsor

Indira Gandhi Medical College, Shimla

Other

Registry information

Official study title

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

Acronym: ModCRF

Important dates

Study start
2010
Primary completion
2012
Study completion
2012
First posted
Sep 26, 2011
Registry last updated
Mar 23, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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