Condition category
Cancer
Date applied
29/09/2006
Date assigned
29/09/2006
Last edited
07/09/2012
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Dr Emilie Wilkes

ORCID ID

Contact details

Derby Hospitals NHS Foundation Trust
Department of Gastroenterology
Derby City General Hospital
Uttoxeter Road
Derby
DE22 3NE
United Kingdom

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 measures

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

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

http://www.dh.gov.uk/Home/fs/en

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

Results - basic reporting

Publication summary

2006 results in http://www.ncbi.nlm.nih.gov/pubmed/16423004

Publication citations

  1. 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.

Additional files

Editorial Notes