Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
N0077075338
Study information
Scientific title
Acronym
Study hypothesis
Does Thalidomide reverse the metabolic effects of cachexia in oesophageal cancer patients?
Ethics approval
Not provided at time of registration
Study design
Randomised controlled trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Not specified
Trial type
Not Specified
Patient information sheet
Not available in web format, please use the contact details below to request a patient information sheet
Condition
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
Phase
Not Specified
Drug names
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 trial start date
01/01/2003
Overall trial end date
30/06/2006
Reason abandoned (if study stopped)
Eligibility
Participant 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)
Participant type
Patient
Age group
Not Specified
Gender
Not Specified
Target number of participants
12
Participant 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
Recruitment start date
01/01/2003
Recruitment end date
30/06/2006
Locations
Countries of recruitment
United Kingdom
Trial participating centre
Derby Hospitals NHS Foundation Trust
Derby
DE22 3NE
United Kingdom
Sponsor information
Organisation
Record Provided by the NHSTCT Register - 2006 Update - Department of Health
Sponsor details
The Department of Health
Richmond House
79 Whitehall
London
SW1A 2NL
United Kingdom
+44 (0)20 7307 2622
dhmail@doh.gsi.org.uk
Sponsor type
Government
Website
Funders
Funder type
Government
Funder name
Derby Hospitals NHS Foundation Trust (UK), NHS R&D Support Funding
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Basic results (scientific)
Publication list
2006 results in http://www.ncbi.nlm.nih.gov/pubmed/16423004
Publication citations
-
Results
Wilkes EA, Freeman JG, Thalidomide: an effective anabolic agent in gastrointestinal cancer cachexia., Aliment. Pharmacol. Ther., 2006, 23, 3, 445-6; author reply 446-7, doi: 10.1111/j.1365-2036.2006.02738.x.