The symptom of fatigue in patients with non-small cell lung cancer MedDRA version: 14.0 Level: LLT Classification code 10029514 Term: Non-small cell lung cancer NOS System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Conditions
Interventions
Trade Name: Provigil
Product Name: Modafinil
Product Code: N/A
Pharmaceutical Form: Capsule
Pharmaceutical form of the placebo: Capsule
Sponsors
University of Oxford
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1) Participant is willing and able to give informed consent for participation in the study 2) Male or female, aged 18 years or above 3) Diagnosed with non-small cell lung Cancer 4) Stage 3a, 3b or stage 4 disease, or recurrent disease after surgery or radiotherapy 5) World Health Organisation performance status of 0-2 6) Screening score of 5 or more in a 10-point numerical rating scale of fatigue severity within two weeks of enrolment 7) Able (in the investigator’s opinion) and willing to comply with all study requirements, including ability to participate for in study for 28 days 8) Willing to allow his or her General Practitioner to be notified of participation in the study. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: The participant may not enter the study if ANY of the following apply: 1) Received radiotherapy or chemotherapy within the last 4 weeks 2) Started on an EGFR tyrosine kinase inhibitor e.g. Gefitinib (Iressa®) and Erlotinib (Tarceva®) within the last 6 weeks. 2) Commenced on antidepressants or steroids (corticosteroids and progestational steroids) within the last 2 weeks 3) Received blood transfusion within the last 2 weeks 4) Potentially fertile woman of child-bearing age 5) Major anxiety requiring intervention in secondary care 6) History of arrhythmia requiring medical intervention 7) Uncontrolled hypertension with blood pressure greater than 160/100 mmHg 8) History of cor pulmonale or left ventricular hypertrophy 9) Currently taking warfarin 10) Previous adverse reaction to modafinil or other CNS stimulant 11) Scheduled elective surgery or other procedures requiring general anaesthesia during the study 12) 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 13) Currently participating in another research study involving an investigational product.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The principal objective of this study is to determine whether modafinil can reduce the level of fatigue experienced by patients with lung cancer.; Secondary Objective: The secondary objectives are as follows: 1) To check that modafinil is safe in patients with lung cancer and does not cause intolerable side-effects 2) To help determine which dose of modafinil should be used for the treatment of fatigue in this patient group 3) To evaluate the effect of modafinil on daytime sleepiness and depression in lung cancer patients ;Primary end point(s): The difference in fatigue score between the treatment (modafinil) group and the placebo group, after 28 days of taking the study intervention | — |
Countries
United Kingdom
Outcome results
None listed