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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00829322
Recruitment Status : Completed
First Posted : January 27, 2009
Last Update Posted : August 19, 2013
Information provided by (Responsible Party):
University of Oxford

Brief Summary:

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.

Condition or disease Intervention/treatment Phase
Carcinoma, Non-Small-Cell Lung Drug: Modafinil Drug: Placebo Phase 4

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 208 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Modafinil for the Treatment of Fatigue in Lung Cancer: a Multicentre, Randomised, Double-blinded, Placebo-controlled Trial
Study Start Date : February 2009
Actual Primary Completion Date : May 2012
Actual Study Completion Date : May 2012

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Fatigue

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

Primary Outcome Measures :
  1. The fatigue subscale of the Functional Assessment of Chronic Illness Therapy measurement system [ Time Frame: 28 days ]

Secondary Outcome Measures :
  1. Epworth Sleepiness Scale [ Time Frame: 28 days ]
  2. Hospital Anxiety and Depression Scale [ Time Frame: 28 days ]
  3. Quality of life linear analogue scale [ Time Frame: 28 days ]
  4. Adverse events [ Time Frame: 28 days ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00829322

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

Publications automatically indexed to this study by Identifier (NCT Number):
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Responsible Party: University of Oxford Identifier: NCT00829322     History of Changes
Other Study ID Numbers: Modafinil/lung/09
First Posted: January 27, 2009    Key Record Dates
Last Update Posted: August 19, 2013
Last Verified: August 2013

Additional relevant MeSH terms:
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Carcinoma, Non-Small-Cell Lung
Signs and Symptoms
Carcinoma, Bronchogenic
Bronchial Neoplasms
Lung Neoplasms
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Lung Diseases
Respiratory Tract Diseases
Central Nervous System Stimulants
Physiological Effects of Drugs
Wakefulness-Promoting Agents
Cytochrome P-450 CYP3A Inducers
Cytochrome P-450 Enzyme Inducers
Molecular Mechanisms of Pharmacological Action