The role of Thalidomide in Reversing Cachexia in Patients with Oesophageal Cancer
| ISRCTN | ISRCTN45162540 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN45162540 |
| Secondary identifying numbers | N0077075338 |
- Submission date
- 29/09/2006
- Registration date
- 29/09/2006
- Last edited
- 07/09/2012
- 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 Emilie Wilkes
Scientific
Scientific
Derby Hospitals NHS Foundation Trust
Department of Gastroenterology
Derby City General Hospital
Uttoxeter Road
Derby
DE22 3NE
United Kingdom
Study information
| Study design | Randomised controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Not specified |
| Study type | Not Specified |
| Participant information sheet | Not available in web format, please use the contact details below to request a patient information sheet |
| Scientific title | |
| Study objectives | Does Thalidomide reverse the metabolic effects of cachexia in oesophageal cancer patients? |
| Ethics approval(s) | Not provided at time of registration |
| Health condition(s) or problem(s) studied | Cancer: Oesophageal |
| Intervention | Thalidomide will be prescribed strictly in accordance with the regulations laid down by S.T.E.P.S. (System for Thalidomide Education & Prescribing Safety). Patients will be established on an isocaloric diet over a 10 day period. The total daily energy content of the diet will be estimated from Harris-Benedict equation for REE with a standard increment above the baseline to allow for activity. Thalidomide will be administered at a dose of 200 mg/day for 14 days. After 14 days, the subjects will continue to remain on the isocaloric diet for another 2 weeks. Body weight and composition will be measured by DEXA scanning at the start of the study, after thalidomide treatment and at the end of the study. REE will be measured by indirect calorimetry using ventilated hood apparatus. Measurements will be made both during fasting state and also post meals at the same intervals as body composition assessments. Urine will be collected for estimation of 24 hr urea nitrogen excretion, creatinine, uric acid, protein at weekly intervals. Routine biochemistry, blood counts, lipids, TFT, cortisol, catecholamines, free fatty acids, non-esterified fatty acids, insulin and lactate. Each patient will be seen for a detailed history and thorough clinical examination at weekly intervals. In addition, the following clinical parameters will be noted; quality of life questionnaire (Karnofsky Index), nutritional status, and a detailed neurological examination will be conducted to look for evidence of neurotoxicity. Sensory nerve action potential amplitudes of median, radial and sural nerve will be measured at baseline (2 readings) and again if indicated by development of neurotoxicity. Development of any signs of neurotoxicity or parasthesia will result in immediate cessation of therapy and objective assessment by nerve conduction study. |
| Intervention type | Drug |
| Pharmaceutical study type(s) | |
| Phase | Not Specified |
| Drug / device / biological / vaccine name(s) | Thalidomide |
| Primary outcome measure | Reduction in metabolic rate, weight gain and improvement in quality of life. |
| Secondary outcome measures | Not provided at time of registration |
| Overall study start date | 01/01/2003 |
| Completion date | 30/06/2006 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Not Specified |
| Sex | Not Specified |
| Target number of participants | 12 |
| Key inclusion criteria | 12 oesophageal cancer patients will be recruited from the endoscopy database. Inclusion criteria: 1. Patients with non obstructing and inoperable oesophageal cancer 2. Able to swallow a semi solid diet (Dysphagia score <3) |
| Key exclusion criteria | 1. Pre menopausal women 2. Patients receiving any adjuvant chemo or radiotherapy 3. Patients with oesophageal obstruction 4. Patients with established neuropathy 5. Patients requiring frequent laser ablation sessions 6. Patients unable to take a constant calorific intake 7. Increased debility |
| Date of first enrolment | 01/01/2003 |
| Date of final enrolment | 30/06/2006 |
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
Record Provided by the NHSTCT Register - 2006 Update - Department of Health
Government
Government
The Department of Health, Richmond House, 79 Whitehall
London
SW1A 2NL
United Kingdom
| Phone | +44 (0)20 7307 2622 |
|---|---|
| dhmail@doh.gsi.org.uk | |
| Website | http://www.dh.gov.uk/Home/fs/en |
Funders
Funder type
Government
Derby Hospitals NHS Foundation Trust (UK), NHS R&D Support Funding
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 | 01/02/2006 | Yes | No |
