The Role of Thalidomide in Reversing Cachexia in Patients with Oesophageal Cancer
| ISRCTN | ISRCTN23944748 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN23944748 |
| Secondary identifying numbers | SDAH/2000/009 |
- Submission date
- 28/04/2006
- Registration date
- 06/06/2006
- Last edited
- 22/08/2012
- 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
Not provided at time of registration
Contact information
Dr Jan Freeman
Scientific
Scientific
Derby Hospitals NHS Foundation Trust
Derby City Hospital
Uttoxeter Road
Derby
DE22 3NE
United Kingdom
Study information
| Study design | Double-blind placebo controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Not specified |
| Study type | Treatment |
| Participant information sheet | Not available in web format, please use the contact details below to request a patient information sheet |
| Scientific title | |
| Study objectives | Thalidomide increases weight (mainly lean body mass). This effect is mediated by suppression of tumour necrosis factor. |
| Ethics approval(s) | Approved by the Derbyshire Research Ethics Committee on 13/12/2000, reference number: 0003/150 |
| Health condition(s) or problem(s) studied | Oesophageal cancer |
| Intervention | Thalidomide versus placebo |
| Intervention type | Drug |
| Pharmaceutical study type(s) | |
| Phase | Not Specified |
| Drug / device / biological / vaccine name(s) | Thalidomide |
| Primary outcome measure | Change in lean body mass |
| Secondary outcome measures | 1. Change in resting energy expenditure 2. Change in total body weight |
| Overall study start date | 10/12/2002 |
| Completion date | 16/06/2006 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | Both |
| Target number of participants | 34 |
| Key inclusion criteria | Adults with non-obstructing and inoperable oesophageal cancer (dysphagia score <3, able to swallow a semi-solid diet) |
| Key exclusion criteria | 1. Pre-menopausal women 2. Patients receiving any adjuvant chemotherapy or radiotherapy 3. Patients with oesophageal obstruction 4. Those with established neuropathy 5. Patients requiring frequent laser ablation sessions 6. Those unable to maintain an adequate caloric intake 7. Increased debility |
| Date of first enrolment | 10/12/2002 |
| Date of final enrolment | 16/06/2006 |
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centre
Derby Hospitals NHS Foundation Trust
Derby
DE22 3NE
United Kingdom
DE22 3NE
United Kingdom
Sponsor information
Derby Hospitals NHS Foundation Trust (UK)
Hospital/treatment centre
Hospital/treatment centre
Derby City Hospital
Uttoxeter Road
Derby
DE22 3NE
England
United Kingdom
| Phone | +44 (0)1332 340 131 |
|---|---|
| Kirsty.Murdoch@derbyhospitals.nhs.uk |
Funders
Funder type
Charity
The research was funded in part by the MAGIC appeal (registered charity number: 1061812) and in part by matched funds from Derby Hospitals Research and Development grant scheme.
No information available
Results and Publications
| 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 |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | results | 01/09/2011 | Yes | No |
