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

Carcinoma, Non-Small-Cell Lung Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00829322
• Other study ID #: Modafinil/lung/09
• Status: Completed
• Phase: Phase 4
• First received: January 26, 2009
• Last updated: August 16, 2013
• Start date: February 2009
• Est. completion date: May 2012

Study information

• Verified date: August 2013
• Source: University of Oxford
• Contact: n/a
• Is FDA regulated: No
• Health authority: United Kingdom: Medicines and Healthcare Products Regulatory Agency
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 208
• Est. completion date: May 2012
• Est. primary completion date: May 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Carcinoma, Non-Small-Cell Lung

Intervention

Drug:
• Modafinil
Modafinil 100mg once daily for 14 days, increasing to 200mg once daily for a further 14 days
• Placebo
One capsule daily for 14 days, increasing to two capsules daily for 14 days

Locations

Country	Name	City	State
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

Sponsors (1)

Lead Sponsor	Collaborator
University of Oxford

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The fatigue subscale of the Functional Assessment of Chronic Illness Therapy measurement system		28 days	No
Secondary	Epworth Sleepiness Scale		28 days	No
Secondary	Hospital Anxiety and Depression Scale		28 days	No
Secondary	Quality of life linear analogue scale		28 days	No
Secondary	Adverse events		28 days	Yes