| Source of record | UK Trials |
| ISRCTN | ISRCTN45162540 |
| Date ISRCTN assigned | 29/09/2006 |
| Local reference number(s) | N0077075338 |
| Public title | The role of the Thalidomide in Reversing Cachexia in Patients with Oesophageal Cancer |
| Scientific title |
|
| Acronym | N/A |
| Disease/condition/study domain | Cancer: Oesophageal |
| Study hypothesis | Does Thalidomide reverse the metabolic effects of cachexia in oesophageal cancer patients? |
| Design/methodology | Randomised controlled trial |
| Research ethics review | No ethics information provided as of 29 September 2006 |
| Countries of trial | United Kingdom |
| Participants - 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) |
| Participants - 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 |
| Patient information material |
|
| Anticipated start date | 01/01/2003 |
| Anticipated end date | 30/06/2006 |
| Status of trial | Completed |
| Target number of participants | 12 |
| Interventions | Randomised Controlled Trial.
Twelve patients with non-obstructing and inoperable oesophageal cancer will be recruited from the endoscopy database. 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. |
| Primary outcome measure(s) | Reduction in metabolic rate, weight gain and improvement in quality of life. |
| Secondary outcome measure(s) | Not provided at time of registration |
| Sources of funding | Derby Hospitals NHS Foundation Trust
NHS R&D Support Funding |
| Sponsor name | Record Provided by the NHSTCT Register - 2006 Update - Department of Health |
| Sponsor details | The Department of Health, Richmond House, 79 Whitehall
London
United Kingdom
SW1A 2NL |
| Sponsor telephone | +44 (0)20 7307 2622 |
| Sponsor email | dhmail@doh.gsi.org.uk |
| Sponsor website | http://www.dh.gov.uk/Home/fs/en |
| Contact name | Dr Emilie Wilkes |
| Contact details | Derby Hospitals NHS Foundation Trust
Department of Gastroenterology
Derby City General Hospital
Uttoxeter Road
Derby
United Kingdom
DE22 3NE |
| More information | For more up-to-date information please go to the ISRCTN link below. |
| Link to record in ISRCTN Register | ISRCTN45162540 |
| Date last extracted from ISRCTN register | 17/04/2008 |
