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Fatigue is a persistent, subjective sense of tiredness, which interferes with a person’s 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 stimulants are the only class of drug established as being directly effective in relieving fatigue. Traditional stimulants, such as methylphenidate (Ritilin), 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.
We have recently completed a small study to determine the feasibility of undertaking a larger, high quality study to assess the effect of modafinil on cancer-related fatigue. Modafinil appeared to improve fatigue rapidly, and was not associated with serious side-effects. Ten out of fifteen patients 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 eight sites in England. Half the patients will take modafinil and the other half will take a 'dummy' tablet every day for amonth. 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 large cohort of patients suffering from this common and debilitating symptom.
Start dates may differ between countries and research sites. The research team are responsible for keeping the information up-to-date.
The recruitment start and end dates are as follows:
Interventional type: Drug;
You can take part if:
You may not be able to take part if:
1) Received radiotherapy or chemotherapy within the last 4 weeks 2) Commenced on antidepressants or steroids (corticosteroids and progestational steroids) within the last 2 weeks 3) Commenced on an EGFR tyrosine kinase inhibitors e.g. Gefitinib (Iressa®) and Erlotinib (Tarceva®) within the last 6 weeks. 4) Received blood transfusion within the last 2 weeks 5) Potentially fertile woman of child-bearing age 6) Major anxiety requiring intervention in secondary care 7) History of arrhythmia requiring medical intervention 8) Uncontrolled hypertension with blood pressure greater than 160/100 mmHg 9) History of cor pulmonale or left ventricular hypertrophy 10) Currently taking warfarin 11) Previous adverse reaction to modafinil or other CNS stimulant 12) Scheduled elective surgery or other procedures requiring general anaesthesia during the study 13) 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 14) Currently participating in another research study involving an investigational product.
Below are the locations for where you can take part in the trial. Please note that not all sites may be open.
The study is sponsored by University of Oxford and funded by MARIE CURIE; SOBELL HOUSE HOSPICE CHARITY; .
Your feedback is important to us. It will help us improve the quality of the study information on this site. Please answer both questions.
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for Trial ID: CPMS 6506
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