Plain English Summary
Trial website
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
N/A
Study information
Scientific title
Acronym
Study hypothesis
To determine the feasibility of conducting a future randomised controlled trial investigating the use of modafinil in cancer-related fatigue (by generating data to allow a sample size calculation, establishing recruitment and attrition rates, determining whether appropriate outcomes measures and assessment intervals have been chosen, and generating limited tolerability data of modafinil in patients with cancer)
Ethics approval
South East Multicentre Research Ethics Committee on 06/07/2005, (ref: 05/MRE01/60)
Study design
Interventional, open-label, uncontrolled pilot study
Primary study design
Interventional
Secondary study design
Non randomised controlled trial
Trial setting
Not specified
Trial type
Quality of life
Patient information sheet
Condition
Non small cell lung cancer
Intervention
Modafinil 100 mg daily for one week, increasing to 200 mg daily for one week
Intervention type
Drug
Phase
Not Specified
Drug names
Modafinil
Primary outcome measure
Change in fatigue
Secondary outcome measures
Change in sleepiness and depression levels
Overall trial start date
26/04/2006
Overall trial end date
18/05/2007
Reason abandoned (if study stopped)
Eligibility
Participant inclusion criteria
1. Histologically or cytologically confirmed non-small cell lung cancer (NSCLC)
2. A fatigue score of four using bimodal scoring in the Chalder fatigue scale
3. World Health Organisation (WHO) performance status of 0-3
4. Ability to give informed consent to participate
Participant type
Patient
Age group
Not Specified
Gender
Not Specified
Target number of participants
20
Participant exclusion criteria
1. Received radiotherapy or chemotherapy within the last four weeks
2. Commenced on antidepressants or steroids (corticosteroids and progestational steroids) within the last two weeks
3. Received blood transfusion within the last two weeks
4. Potentially fertile women of child-bearing age
5. Uncontrolled moderate to severe hypertension, arrhythmia
6. Previous adverse reaction to modafinil or other central nervous system (CNS) stimulant
7. Current active involvement in another clinical trial
Recruitment start date
26/04/2006
Recruitment end date
18/05/2007
Locations
Countries of recruitment
United Kingdom
Trial participating centre
Palliative Care Office
Cambridge
CB2 2QQ
United Kingdom
Funders
Funder type
Government
Funder name
Internal funding from Addenbrookes Hospital, Cambridge, UK and from Peterborough District Hospital Peterborough (UK)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Basic results (scientific)
Publication list
1. 2009 results in http://www.ncbi.nlm.nih.gov/pubmed/19270033
Publication citations
-
Results
Spathis A, Dhillan R, Booden D, Forbes K, Vrotsou K, Fife K, Modafinil for the treatment of fatigue in lung cancer: a pilot study., Palliat Med, 2009, 23, 4, 325-331, doi: 10.1177/0269216309102614.