A Prospective Randomised Pilot Study of Metformin and Lifestyle Intervention in the Prevention of Metabolic Syndrome due to Androgen Deprivation Therapy in Prostate Cancer - Metformin use in patients on ADT to prevent Metabolic Syndrome
- Conditions
- MedDRA version: 9.1Level: LLTClassification code 10001186Term: Adenocarcinoma of prostatePatients with prostate cancer on androgen deprivation therapy (ADT). Randomisation between standard treatment with ADT only, and the additional use of metformin with dietary and exercise advice.Aim is to reduce the prevalence of metabolic syndrome in the intervention arm - this is a condition linked to ADT in prostate cancer patientsMedDRA version: 9.1Level: LLTClassification code 10052066Term: Metabolic syndrome
- Registration Number
- EUCTR2007-002815-20-GB
- Lead Sponsor
- Royal Surrey County Hospital
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Authorised-recruitment may be ongoing or finished
- Sex
- Male
- Target Recruitment
- Not specified
Male patients (all will be >18 in the study group)
Histologically confirmed adenocarcinoma of the prostate
Planned androgen deprivation therapy with LHRH analogue
Ability to give adequately informed consent to participate in study
WHO Performance status 0-1
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range
Pre-existing Diabetes mellitus
Renal impairment - serum creatinine > 130 µmol/L, GFR < 40 mls/min
Cardiac failure
Respiratory failure
Myocardial infarction within 6 months
Hepatic impairment - LFTs >1.5x upper limit of normal
Alcoholism
All of the above are contra-indications to metformin therapy.
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method