Trials / Unknown
UnknownNCT05367284
Perioperative Testosterone Replacement Therapy in Sarcopenic Male Colorectal Cancer Patients
Use of Perioperative Testosterone Replacement Therapy (TRT) in Sarcopenic Male Colorectal Cancer Patients - A Single Arm Open Label Feasibility Study
- Status
- Unknown
- Phase
- —
- Study type
- Observational
- Enrollment
- 30 (estimated)
- Sponsor
- London North West Healthcare NHS Trust · Academic / Other
- Sex
- Male
- Age
- 45 Years
- Healthy volunteers
- Not accepted
Summary
With increasing age and the additional impact from the bowel cancer and the chemotherapy and/ or radiotherapy it has been described that testosterone (a male hormone produced naturally in the body) levels are reduced. Testosterone has an impact on numerous body functions including the muscle mass and quality. Previous studies have identified that muscle mass is reduced as a result of ageing but also because of the deleterious effect of cancer and chemotherapy and/or radiotherapy. There is growing evidence from published studies that patients with better muscle mass and quality, do better after surgery. Mr Jenkins and his team are therefore looking at ways, the investigators can try and prevent or reduce this muscle loss and therefore improve patient outcomes. The aim of this study is to assess whether using testosterone replacement therapy in the form of a topically applied gel daily for a total of 12 weeks, is feasible and acceptable by the patients who are diagnosed with colorectal cancer and are waiting to undergo surgery. The investigators will also collect information related to the testosterone replacement therapy such as questionnaires on the quality of life, fatigue and muscle mass, and blood biomarker changes in the blood.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Testosterone | Testogel 16.2 miligrams/ gram (mg/g) gel |
Timeline
- Start date
- 2022-01-15
- Primary completion
- 2023-03-01
- Completion
- 2023-03-01
- First posted
- 2022-05-10
- Last updated
- 2022-05-10
Locations
1 site across 1 country: United Kingdom
Source: ClinicalTrials.gov record NCT05367284. Inclusion in this directory is not an endorsement.