The use of thalidomide as a treatment for cancer cachexia
ISRCTN | ISRCTN51456701 |
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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
Contact information
Dr Susi Green
Scientific
Scientific
Gastroenterology Dept
Queen Alexandra Hospital
Cosham
Portsmouth
PO6 3LY
United Kingdom
Phone | +44 (0)2392 286255 |
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susi@doctors.org.uk |
Study information
Study design | Randomised controlled trial |
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Primary study design | Interventional |
Secondary study design | Randomised controlled trial |
Study setting(s) | Hospital |
Study type | Treatment |
Scientific title | The use of thalidomide as a treatment for cancer cachexia |
Study objectives | 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(s) | Not provided at time of registration |
Health condition(s) or problem(s) studied | Cachexia associated with upper gastrointestinal adenocarcinoma |
Intervention | Thalidomide or placebo |
Intervention type | Drug |
Pharmaceutical study type(s) | |
Phase | Phase III |
Drug / device / biological / vaccine name(s) | Thalidomide |
Primary outcome measure | 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 study start date | 03/10/2005 |
Completion date | 28/02/2011 |
Eligibility
Participant type(s) | Patient |
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Age group | Adult |
Lower age limit | 18 Years |
Sex | Both |
Target number of participants | 180 |
Key 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 |
Key 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 |
Date of first enrolment | 03/10/2005 |
Date of final enrolment | 28/02/2011 |
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centre
Gastroenterology Dept
Portsmouth
PO6 3LY
United Kingdom
PO6 3LY
United Kingdom
Sponsor information
Portsmouth Hospitals Trust (UK)
Hospital/treatment centre
Hospital/treatment centre
Kate Greenwood
Gloucester House
Queen Alexandra Hospital
Southwick Hill Road
Cosham
Portsmouth
PO6 3LY
England
United Kingdom
https://ror.org/009fk3b63 |
Funders
Funder type
Charity
The Moulton Charitable Trust (UK)
No information available
Results and Publications
Intention to publish date | |
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Individual participant data (IPD) Intention to share | No |
IPD sharing plan summary | Not provided at time of registration |
Publication and dissemination plan | Not provided at time of registration |
IPD sharing plan |
Editorial Notes
16/03/2017: No publications found in PubMed, verifying study status with principal investigator.