Condition category
Cancer
Date applied
23/09/2005
Date assigned
23/11/2005
Last edited
10/06/2014
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Contact information

Type

Scientific

Primary contact

Dr Susi Green

ORCID ID

Contact details

Gastroenterology Dept
Queen Alexandra Hospital
Cosham
Portsmouth
PO6 3LY
United Kingdom
+44 (0)2392 286255
susi@doctors.org.uk

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

220105v1

Study information

Scientific title

Acronym

Study hypothesis

Thalidomide can attenuate or reverse both the total weight loss and loss of lean body mass in the cachexia associated with upper gastrointestinal adenocarcinomas.

On 15/02/2011 the anticipated end date for this trial was changed from 03/10/2007 to 28/02/2011.

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

Hospitals

Trial type

Treatment

Patient information sheet

Condition

Cachexia associated with upper gastrointestinal adenocarcinoma

Intervention

Thalidomide or placebo

Intervention type

Drug

Phase

Phase III

Drug names

Thalidomide

Primary outcome measures

To evaluate the ability of thalidomide, as compared with placebo, to attenuate loss of weight in patients with incurable upper gastrointestinal carcinomas

Secondary outcome measures

1. To assess any impact on functional or overall quality of life
2. To calculate any change in overall survival
3. To calculate any change in lean muscle mass
4. To calculate any change in grip strength
5. To obtain serum and urinary profiles of factors previously implicated in the development of cachexia for both the control and treated group
6. To document the safety and tolerability of thalidomide in patients with incurable upper gastrointestinal adenocarcinomas

Overall trial start date

03/10/2005

Overall trial end date

28/02/2011

Reason abandoned

Eligibility

Participant inclusion criteria

1. Have a histological or cytological diagnosis of upper gastrointestinal (oesophagus, stomach, small bowel, ampulla or pancreas) adenocarcinoma
2. Have no curative options available which are acceptable to the patient
3. Have lost 5% total of pre-morbid body weight or be actively losing at least 1 kg per month
4. Weight loss may be self-reported or obtained from previous documentation
5. If a patient is using megesterol acetate (Megace, Megestrol) or eicosapentaenoic acid (Maxepa, Omacor, Prosure) and has been on a stable dose for at least 1 month but losing weight at the stated rate despite this they may be included. They will be asked to continue on this same dose for the course of the study.
6. Those using corticosteroids, non-steroidal anti-inflammatory drugs and other nutritional supplements or complementary therapies will not be restricted, the doses used will be recorded at each clinic visit
7. Have a predicted survival of at least 8 weeks
8. Aged over 18 years at the time of entry into the trial
9. Able to understand the information given and to give written informed consent
10. Able to take oral medications
11. Agree to the conditions of use of thalidomide as enumerated
12. Women who have not had their ovaries or uterus removed or who have been post-menopausal for at least 2 years, must have a negative urinary pregnancy test and negative pregnancy tests repeated on a monthly basis until 1 month after completion of the trial

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

180

Participant exclusion criteria

1. Unable to provide informed consent
2. Involved in any other trial during the study period
3. Received chemotherapy or radiotherapy within the previous 4 weeks
4. Expected to receive chemotherapy or radiotherapy in the following 6 months
5. Using varying doses of megesterol acetate or eicosapentaenoic acid
6. Clinically detectable ascites or oedema
7. Unable to take oral medication
8. Pregnant or breastfeeding
9. Unable or considered unlikely to avoid pregnancy
10. Evidence of peripheral neuropathy, severe constipation, vertigo or vestibular disease
11. Previous adverse reaction to thalidomide
12. Any condition judged by the investigator to make the patient unsuitable for inclusion into the study due to interference with absorption of the drug or the overall interpretation of the data

Recruitment start date

03/10/2005

Recruitment end date

28/02/2011

Locations

Countries of recruitment

United Kingdom

Trial participating centre

Gastroenterology Dept
Portsmouth
PO6 3LY
United Kingdom

Sponsor information

Organisation

Portsmouth Hospitals Trust (UK)

Sponsor details

Kate Greenwood
Gloucester House
Queen Alexandra Hospital
Southwick Hill Road
Cosham
Portsmouth
PO6 3LY
United Kingdom

Sponsor type

Government

Website

Funders

Funder type

Charity

Funder name

The Moulton Charitable Trust (UK)

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

Publication citations

Additional files

Editorial Notes