Modafinil for the Treatment of Fatigue in Lung Cancer V9.0

August 16, 2013 updated by: University of Oxford

Modafinil for the Treatment of Fatigue in Lung Cancer: a Multicentre, Randomised, Double-blinded, Placebo-controlled Trial

Fatigue is a persistent, subjective sense of tiredness, which interferes with a person's usual ability to function. It is believed to be both the most common and the most distressing symptom experienced by those with cancer. Despite the magnitude of the problem, there has been inadequate research into the management of cancer-related fatigue.

Central nervous system (CNS) stimulants are the only class of drug established as being directly effective in relieving fatigue. Traditional stimulants, such as methylphenidate (Ritalin), can cause side-effects such as difficulty sleeping at night and anxiety. Modafinil is a relatively new stimulant with few side-effects. There is increasing evidence that modafinil can reduce fatigue in healthy individuals and patients with chronic, non-cancer conditions. No good quality studies have been published evaluating modafinil in patients with cancer, despite multiple calls for such research to be undertaken.

The investigators have completed a small study to determine the feasibility of undertaking a larger, high quality study to assess the effect of modafinil on fatigue in patients with lung cancer. Modafinil appeared to improve fatigue rapidly and was not associated with serious side-effects. Ten of the fifteen patients who completed the study chose to continue modafinil long-term. However, the study was too small for definite conclusions to be drawn.

This larger, definitive study, funded by a National Cancer Research Institute research award, will establish more clearly whether modafinil can improve fatigue in patients with lung cancer. Two hundred and six patients will be recruited from a number of sites across the UK. Half of the patients will take modafinil, and the other half will take a 'dummy' tablet every day for a month. The fatigue levels of the two groups will be compared. Confirmation that modafinil can relieve cancer-related fatigue could have a highly significant impact on the quality of life of the very large number of patients suffering from this common and distressing symptom.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

208

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United Kingdom
      • Aylesbury, United Kingdom
        • Stoke Mandeville Hospital
      • Cheshire, United Kingdom
        • Macclesfield District Hospital
      • County Durham, United Kingdom
        • University Hospital of North Tees
      • Essex, United Kingdom
        • Basildon and Thurrock University Hospitals
      • Hampshire, United Kingdom
        • Basingstoke And North Hampshire Hospital
      • Kent, United Kingdom
        • East Kent University Hospitals
      • Kings Lynn, United Kingdom
        • Queen Elizabeth Hospital
      • Llandough, United Kingdom
        • University Hospital
      • London, United Kingdom
        • St George's Hospital
      • London, United Kingdom
        • Royal Marsden Hospital Fulham Road
      • London, United Kingdom
        • Royal Marsden Hospital Sutton
      • Manchester, United Kingdom
        • Christie Hospital
      • Manchester, United Kingdom
        • Wythenshawe Hospital
      • Middlesborough, United Kingdom
        • James Cook University Hospital
      • North Yorkshire, United Kingdom
        • Harrogate and District NHS Foundation Trust
      • Oxford, United Kingdom
        • Churchill Hospital
      • Papworth Everard, United Kingdom
        • Papworth Hospital
      • Pembrokeshire, United Kingdom
        • Withybush General Hospital
      • Peterborough, United Kingdom
        • Peterborough District Hospital
      • Surrey, United Kingdom
        • Royal Surrey County Hospital
      • Swindon, United Kingdom
        • Great Western Hospital
      • Uxbridge, United Kingdom
        • Hillingdon Hospital
      • West Yorkshire, United Kingdom
        • Calderdale and Huddersfield NHS Foundation Trust
      • West Yorkshire, United Kingdom
        • Mid Yorkshire Hospital NHS Trust

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Participant is willing and able to give informed consent for participation in the study
  • Male or female, aged 18 years or above
  • Diagnosed with NSCLC
  • Stage 3a, 3b or stage 4 disease, or recurrent disease after surgery or radiotherapy
  • WHO performance status of 0-2
  • Participant has a screening score of 5 or more in a 10-point numerical rating scale (NRS) of fatigue severity within two weeks of enrolment
  • Able (in the investigator's opinion) and willing to comply with all study requirements, including ability to participate for in study for 28 days
  • Willing to allow his or her General Practitioner to be notified of participation in the study.

Exclusion Criteria:

  • Received radiotherapy or chemotherapy within the last 4 weeks
  • Commenced on an EGFR tyrosine kinase inhibitors eg Gefitinib and Erlotinib within the last 6 weeks.
  • Commenced on antidepressants or steroids (corticosteroids and progestational steroids) within the last 2 weeks
  • Received blood transfusion within the last 2 weeks
  • Potentially fertile woman of child-bearing age
  • Major anxiety requiring intervention in secondary care
  • History of arrhythmia requiring medical intervention
  • Uncontrolled hypertension with blood pressure greater than 160/100 mmHg
  • History of cor pulmonale or left ventricular hypertrophy
  • Currently taking warfarin
  • Previous adverse reaction to modafinil or other CNS stimulant
  • Scheduled elective surgery or other procedures requiring general anaesthesia during the study
  • Any other significant disease or disorder which, in the opinion of the Investigator, may either put the participant at risk because of participation in the study, or affect the participant's ability to participate in the study
  • Currently participating in another research study involving an investigational product.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Treatment group
Drug: Modafinil
Modafinil 100mg once daily for 14 days, increasing to 200mg once daily for a further 14 days
Placebo Comparator: Control group
Drug: Placebo
One capsule daily for 14 days, increasing to two capsules daily for 14 days

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
The fatigue subscale of the Functional Assessment of Chronic Illness Therapy measurement system
Time Frame: 28 days
28 days

Secondary Outcome Measures

Outcome Measure
Time Frame
Adverse events
Time Frame: 28 days
28 days
Epworth Sleepiness Scale
Time Frame: 28 days
28 days
Hospital Anxiety and Depression Scale
Time Frame: 28 days
28 days
Quality of life linear analogue scale
Time Frame: 28 days
28 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Oxford

Investigators

  • Principal Investigator: Bee Wee, PhD, University of Oxford

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2009

Primary Completion (Actual)

May 1, 2012

Study Completion (Actual)

May 1, 2012

Study Registration Dates

First Submitted

January 26, 2009

First Submitted That Met QC Criteria

January 26, 2009

First Posted (Estimate)

January 27, 2009

Study Record Updates

Last Update Posted (Estimate)

August 19, 2013

Last Update Submitted That Met QC Criteria

August 16, 2013

Last Verified

August 1, 2013

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Modafinil/lung/09

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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