Modafinil for the treatment of fatigue in lung cancer: a pilot study

ISRCTN	ISRCTN82265570
DOI	https://doi.org/10.1186/ISRCTN82265570
Secondary identifying numbers	N/A

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

Dr Anna Spathis
Scientific

Palliative Care Office
Box 193
Addenbrookes Hospital
Cambridge
CB2 2QQ
United Kingdom

Study design	Interventional, open-label, uncontrolled pilot study
Primary study design	Interventional
Secondary study design	Non randomised controlled trial
Study setting(s)	Not specified
Study type	Quality of life
Scientific title	Modafinil for the treatment of fatigue in lung cancer: a pilot study
Study objectives	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(s)	South East Multicentre Research Ethics Committee on 06/07/2005, (ref: 05/MRE01/60)
Health condition(s) or problem(s) studied	Non small cell lung cancer
Intervention	Modafinil 100 mg daily for one week, increasing to 200 mg daily for one week
Intervention type	Drug
Pharmaceutical study type(s)
Phase	Not Specified
Drug / device / biological / vaccine name(s)	Modafinil
Primary outcome measure	Change in fatigue
Secondary outcome measures	Change in sleepiness and depression levels
Overall study start date	26/04/2006
Completion date	18/05/2007

Participant type(s)	Patient
Age group	Not Specified
Sex	Not Specified
Target number of participants	20
Total final enrolment	208
Key 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
Key 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
Date of first enrolment	26/04/2006
Date of final enrolment	18/05/2007

Palliative Care Office

Cambridge
CB2 2QQ
United Kingdom

Cambridge University Hospitals NHS Foundation Trust (UK)
University/education

Research and Development Department
Box 146
Addenbrookes Hospital
Cambridge
CB2 2QQ
England
United Kingdom

"ROR"	https://ror.org/04v54gj93

Government

Internal funding from Addenbrookes Hospital, Cambridge, UK and from Peterborough District Hospital Peterborough (UK)

No information available

Intention to publish date
Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
Publication and dissemination plan	Not provided at time of registration
IPD sharing plan	Not provided at time of registration

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Results article	results	01/06/2009		Yes	No
Plain English results			26/10/2022	No	Yes

25/10/2022: Cancer Research UK plain English results link and total final enrolment added.