The use of thalidomide as a treatment for cancer cachexia

ISRCTN	ISRCTN51456701
DOI	https://doi.org/10.1186/ISRCTN51456701
Protocol serial number	220105v1
Sponsor	Portsmouth Hospitals Trust (UK)
Funder	The Moulton Charitable Trust (UK)

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

Primary study design	Interventional
Study design	Randomised controlled trial
Secondary study design	Randomised controlled trial
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
Phase	Phase III
Drug / device / biological / vaccine name(s)	Thalidomide
Primary outcome measure(s)	To evaluate the ability of thalidomide, as compared with placebo, to attenuate loss of weight in patients with incurable upper gastrointestinal carcinomas
Key secondary outcome measure(s)	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
Completion date	28/02/2011

Eligibility

Participant type(s)	Patient
Age group	Adult
Lower age limit	18 Years
Sex	All
Target sample size at registration	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

United Kingdom
England

Study participating centre

Gastroenterology Dept

Portsmouth
PO6 3LY
United Kingdom

Results and Publications

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	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.