Plain English Summary
Trial website
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
The use of thalidomide as a treatment for cancer cachexia
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
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