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

Phase 4
18 Years
Open (Enrolling)
Carcinoma, Non-Small-Cell Lung

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Trial Information

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

Inclusion Criteria:

- Participant is willing and able to give informed consent for participation in the

- Male or female, aged 18 years or above

- Diagnosed with NSCLC with confirmatory histology or cytology

- Stage 3b or stage 4 disease, or recurrent disease after surgery

- 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 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

Type of Study:


Study Design:

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

Outcome Measure:

The fatigue subscale of the Functional Assessment of Chronic Illness Therapy measurement system

Outcome Time Frame:

28 days

Safety Issue:



United Kingdom: Medicines and Healthcare Products Regulatory Agency

Study ID:




Start Date:

February 2009

Completion Date:

September 2012

Related Keywords:

  • Carcinoma, Non-Small-Cell Lung
  • Carcinoma
  • Carcinoma, Non-Small-Cell Lung
  • Lung Neoplasms