Condition category
Cancer
Date applied
28/04/2006
Date assigned
06/06/2006
Last edited
22/08/2012
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 Jan Freeman

ORCID ID

Contact details

Derby Hospitals NHS Foundation Trust
Derby City Hospital
Uttoxeter Road
Derby
DE22 3NE
United Kingdom

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

SDAH/2000/009

Study information

Scientific title

Acronym

Study hypothesis

Thalidomide increases weight (mainly lean body mass). This effect is mediated by suppression of tumour necrosis factor.

Ethics approval

Approved by the Derbyshire Research Ethics Committee on 13/12/2000, reference number: 0003/150

Study design

Double-blind placebo controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Not specified

Trial type

Treatment

Patient information sheet

Not available in web format, please use the contact details below to request a patient information sheet

Condition

Oesophageal cancer

Intervention

Thalidomide versus placebo

Intervention type

Drug

Phase

Not Specified

Drug names

Thalidomide

Primary outcome measures

Change in lean body mass

Secondary outcome measures

1. Change in resting energy expenditure
2. Change in total body weight

Overall trial start date

10/12/2002

Overall trial end date

16/06/2006

Reason abandoned

Eligibility

Participant inclusion criteria

Adults with non-obstructing and inoperable oesophageal cancer (dysphagia score <3, able to swallow a semi-solid diet)

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

34

Participant 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

Recruitment start date

10/12/2002

Recruitment end date

16/06/2006

Locations

Countries of recruitment

United Kingdom

Trial participating centre

Derby Hospitals NHS Foundation Trust
Derby
DE22 3NE
United Kingdom

Sponsor information

Organisation

Derby Hospitals NHS Foundation Trust (UK)

Sponsor details

Derby City Hospital
Uttoxeter Road
Derby
DE22 3NE
United Kingdom
+44 (0)1332 340 131
Kirsty.Murdoch@derbyhospitals.nhs.uk

Sponsor type

Government

Website

Funders

Funder type

Charity

Funder name

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.

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

1. 2011 results in http://www.ncbi.nlm.nih.gov/pubmed/21521389

Publication citations

  1. Results

    Wilkes EA, Selby AL, Cole AT, Freeman JG, Rennie MJ, Khan ZH, Poor tolerability of thalidomide in end-stage oesophageal cancer., Eur J Cancer Care (Engl), 2011, 20, 5, 593-600, doi: 10.1111/j.1365-2354.2011.01255.x.

Additional files

Editorial Notes