Condition category
Cancer
Date applied
12/04/2006
Date assigned
24/04/2006
Last edited
14/07/2011
Prospective/Retrospective
Prospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Contact information

Type

Scientific

Primary contact

Dr Anna Spathis

ORCID ID

Contact details

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

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 measures

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

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

Sponsor information

Organisation

Cambridge University Hospitals NHS Foundation Trust (UK)

Sponsor details

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

Sponsor type

University/education

Website

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

Results - basic reporting

Publication summary

1. 2009 results in http://www.ncbi.nlm.nih.gov/pubmed/19270033

Publication citations

  1. 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.

Additional files

Editorial Notes