The Role of Thalidomide in Reversing Cachexia in Patients with Oesophageal Cancer
| ISRCTN | ISRCTN23944748 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN23944748 |
| Protocol serial number | SDAH/2000/009 |
| Sponsor | Derby Hospitals NHS Foundation Trust (UK) |
| Funder | 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. |
- 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
| Primary study design | Interventional |
|---|---|
| Study design | Double-blind placebo controlled trial |
| Secondary study design | Randomised controlled trial |
| Study type | Participant 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 |
| Phase | Not Specified |
| Drug / device / biological / vaccine name(s) | Thalidomide |
| Primary outcome measure(s) |
Change in lean body mass |
| Key secondary outcome measure(s) |
1. Change in resting energy expenditure |
| Completion date | 16/06/2006 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | All |
| Target sample size at registration | 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
- United Kingdom
- England
Study participating centre
Derby Hospitals NHS Foundation Trust
Derby
DE22 3NE
United Kingdom
DE22 3NE
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 |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | results | 01/09/2011 | Yes | No | |
| Participant information sheet | Participant information sheet | 11/11/2025 | 11/11/2025 | No | Yes |
