Modafinil for the treatment of fatigue in lung cancer: a multicentre, randomised, double-blinded, placebo-controlled trial - Modafinil for the treatment of fatigue in lung cancer

niversity of Oxford0 个研究点目标入组 206 人开始时间: 2009年4月14日最近更新: 2019年11月25日

适应症

试验速览

暂无简介。

•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

•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.

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