Modafinil for the treatment of fatigue in lung cancer: a pilot study
| ISRCTN | ISRCTN82265570 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN82265570 |
| Protocol serial number | N/A |
| Sponsor | Cambridge University Hospitals NHS Foundation Trust (UK) |
| Funder | Internal funding from Addenbrookes Hospital, Cambridge, UK and from Peterborough District Hospital Peterborough (UK) |
- Submission date
- 12/04/2006
- Registration date
- 24/04/2006
- Last edited
- 26/10/2022
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Cancer
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Plain English summary of protocol
Contact information
Dr Anna Spathis
Scientific
Scientific
Palliative Care Office
Box 193
Addenbrookes Hospital
Cambridge
CB2 2QQ
United Kingdom
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Interventional, open-label, uncontrolled pilot study |
| Secondary study design | Non randomised controlled trial |
| 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 |
| Phase | Not Specified |
| Drug / device / biological / vaccine name(s) | Modafinil |
| Primary outcome measure(s) |
Change in fatigue |
| Key secondary outcome measure(s) |
Change in sleepiness and depression levels |
| Completion date | 18/05/2007 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Not Specified |
| Sex | Not Specified |
| Target sample size at registration | 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 |
Locations
Countries of recruitment
- United Kingdom
- England
Study participating centre
Palliative Care Office
Cambridge
CB2 2QQ
United Kingdom
CB2 2QQ
United Kingdom
Results and Publications
| Individual participant data (IPD) Intention to share | No |
|---|---|
| IPD sharing plan summary | Not provided at time of registration |
| IPD sharing plan | Not provided at time of registration |
Study outputs
| 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 |
Editorial Notes
25/10/2022: Cancer Research UK plain English results link and total final enrolment added.
