The TERESA feasibility study
Research type
Research Study
Full title
Use of perioperative TEstosterone REplacement therapy (TRT) in SArcopenic male colorectal cancer patients – A single arm open label feasibility study
IRAS ID
304030
Contact name
JT (Ian) Jenkins
Contact email
Sponsor organisation
London North West University Hospital Trust
Duration of Study in the UK
1 years, 4 months, 21 days
Research summary
In preparation for a major surgery, it is becoming common practice to fully utilise the timeframe before surgery in order to optimise the patient to withstand the physical stress of the surgery. This practice carries through the surgery to the post-operative time as well, in order to ensure a quick and successful recovery.
Evidence suggests that patients who have greater muscle mass and better muscle quality have better post-operative outcomes, fewer complications and longer survival. In cancer patients the disease process, the chemotherapy and/or radiotherapy along with other factors reduce the muscle mass and deteriorate its quality. This could be profoundly influenced by the use of medications which have a direct impact on the muscle, such as the testosterone (male hormone naturally produced in the body).
With increasing age and the additional impact from the bowel cancer and the chemotherapy and/ or radiotherapy, it has been described that testosterone levels in males, are reduced. Testosterone replacement therapy is already a recognised treatment for hypogonadism (low testosterone) in males, and evidence exists that it improves the muscle quantity and quality. Testosterone replacement has successfully been previously used in palliative cancer patients in order to improve their muscle mass.
The aim of this study is to assess whether the use of testosterone replacement therapy in the form of a topically applied gel daily for a total of 12 weeks in the perioperative period, is feasible and acceptable by male patients who are diagnosed with colorectal cancer and are waiting to undergo major surgery. The treatment will start before they undergo surgery and will continue in the post-operative time frame in order to complete the 12 weeks.
The results of this study will allow us to identify if this is feasible and acceptable as a mode of perioperative intervention to improve surgical outcomes in colorectal cancer patients.
REC name
East of Scotland Research Ethics Service REC 2
REC reference
21/ES/0102
Date of REC Opinion
28 Oct 2021
REC opinion
Further Information Favourable Opinion