|
ISRCTN
|
ISRCTN23944748
|
|
ClinicalTrials.gov identifier
|
|
|
Public title
|
The Role of Thalidomide in Reversing Cachexia in Patients with Oesophageal Cancer
|
|
Scientific title
|
|
|
Acronym
|
N/A
|
|
Serial number at source
|
SDAH/2000/009
|
|
Study hypothesis
|
Thalidomide increases weight (mainly lean body mass). This effect is mediated by suppression of tumour necrosis factor.
|
|
Lay summary
|
Not provided at time of registration
|
|
Ethics approval
|
Approved by the Derbyshire Research Ethics Committee on 13/12/2000, reference number: 0003/150
|
|
Study design
|
Double-blind placebo controlled trial
|
|
Countries of recruitment
|
United Kingdom
|
|
Disease/condition/study domain
|
Oesophageal cancer
|
|
Participants - inclusion criteria
|
Adults with non-obstructing and inoperable oesophageal cancer (dysphagia score <3, able to swallow a semi-solid diet)
|
|
Participants - 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
|
|
Anticipated start date
|
10/12/2002
|
|
Anticipated end date
|
16/06/2006
|
|
Status of trial
|
Completed |
|
Patient information material
|
Not available in web format, please use the contact details below to request a patient information sheet
|
|
Target number of participants
|
34
|
|
Interventions
|
Thalidomide versus placebo
|
|
Primary outcome measure(s)
|
Change in lean body mass
|
|
Secondary outcome measure(s)
|
1. Change in resting energy expenditure
2. Change in total body weight
|
|
Sources of funding
|
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.
|
|
Trial website
|
|
|
Publications
|
|
|
Contact name
|
Dr
Jan
Freeman
|
|
Address
|
Derby Hospitals NHS Foundation Trust
Derby City Hospital
Uttoxeter Road
|
|
City/town
|
Derby
|
|
Zip/Postcode
|
DE22 3NE
|
|
Country
|
United Kingdom
|
|
Sponsor
|
Derby Hospitals NHS Foundation Trust (UK)
|
|
Address
|
Derby City Hospital
Uttoxeter Road
|
|
City/town
|
Derby
|
|
Zip/Postcode
|
DE22 3NE
|
|
Country
|
United Kingdom
|
|
Tel
|
+44 (0)1332 340 131
|
|
Email
|
Kirsty.Murdoch@derbyhospitals.nhs.uk
|
|
Date applied
|
28/04/2006
|
|
Last edited
|
09/05/2012
|
|
Date ISRCTN assigned
|
06/06/2006
|
