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

Phase 1

• Conditions: 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)

• Registration Number: EUCTR2008-006486-88-GB
• Lead Sponsor: niversity of Oxford

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2009-04-14
• Study Completion: 2012-06-11
• Last Update Posted: 25 November 2019

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: Not specified
• Target Recruitment: 206

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

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.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified