The use of thalidomide as a treatment for cancer cachexia

ISRCTN ISRCTN51456701
DOI https://doi.org/10.1186/ISRCTN51456701
Secondary identifying numbers 220105v1
Submission date
23/09/2005
Registration date
23/11/2005
Last edited
16/03/2017
Recruitment status
No longer recruiting
Overall study status
Completed
Condition category
Cancer
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Record updated in last year

Plain English summary of protocol

http://www.cancerhelp.org.uk/trials/a-trial-looking-at-thalidomide-for-cancer-patients-with-weight-loss.

Contact information

Dr Susi Green
Scientific

Gastroenterology Dept
Queen Alexandra Hospital
Cosham
Portsmouth
PO6 3LY
United Kingdom

Phone +44 (0)2392 286255
Email susi@doctors.org.uk

Study information

Study designRandomised controlled trial
Primary study designInterventional
Secondary study designRandomised controlled trial
Study setting(s)Hospital
Study typeTreatment
Scientific titleThe use of thalidomide as a treatment for cancer cachexia
Study objectivesThalidomide 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(s)Not provided at time of registration
Health condition(s) or problem(s) studiedCachexia associated with upper gastrointestinal adenocarcinoma
InterventionThalidomide or placebo
Intervention typeDrug
Pharmaceutical study type(s)
PhasePhase III
Drug / device / biological / vaccine name(s)Thalidomide
Primary outcome measureTo evaluate the ability of thalidomide, as compared with placebo, to attenuate loss of weight in patients with incurable upper gastrointestinal carcinomas
Secondary outcome measures1. 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 study start date03/10/2005
Completion date28/02/2011

Eligibility

Participant type(s)Patient
Age groupAdult
Lower age limit18 Years
SexBoth
Target number of participants180
Key inclusion criteria1. 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
Key exclusion criteria1. 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
Date of first enrolment03/10/2005
Date of final enrolment28/02/2011

Locations

Countries of recruitment

  • England
  • United Kingdom

Study participating centre

Gastroenterology Dept
Portsmouth
PO6 3LY
United Kingdom

Sponsor information

Portsmouth Hospitals Trust (UK)
Hospital/treatment centre

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

ROR logo "ROR" https://ror.org/009fk3b63

Funders

Funder type

Charity

The Moulton Charitable Trust (UK)

No information available

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to shareNo
IPD sharing plan summaryNot provided at time of registration
Publication and dissemination planNot provided at time of registration
IPD sharing plan

Editorial Notes

16/03/2017: No publications found in PubMed, verifying study status with principal investigator.