Status:
COMPLETED
Modafinil for the Treatment of Fatigue in Lung Cancer V9.0
Lead Sponsor:
University of Oxford
Conditions:
Carcinoma, Non-Small-Cell Lung
Eligibility:
All Genders
18+ years
Phase:
PHASE4
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 experienc...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
February 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 1 2012
Estimated Enrollment :
208 Patients enrolled
Trial Details
Trial ID
NCT00829322
Start Date
February 1 2009
End Date
May 1 2012
Last Update
August 19 2013
Active Locations (24)
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1
Stoke Mandeville Hospital
Aylesbury, United Kingdom
2
Macclesfield District Hospital
Cheshire, United Kingdom
3
University Hospital of North Tees
County Durham, United Kingdom
4
Basildon and Thurrock University Hospitals
Essex, United Kingdom