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Perioperative Testosterone Replacement Therapy in Sarcopenic Male Colorectal Cancer Patients

NCT05367284 · Status: UNKNOWN · Type: OBSERVATIONAL · Enrollment: 30

Last updated 2022-05-10

No results posted yet for this study

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

DRUG

Testosterone

Testogel 16.2 miligrams/ gram (mg/g) gel

Sponsors & Collaborators

  • London North West Healthcare NHS Trust

    lead OTHER

Principal Investigators

  • JT Jenkins, MD, FRCS · London North West University Hospital Healthcare NHS Trust

Eligibility

Min Age
45 Years
Sex
MALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-01-15
Primary Completion
2023-03-31
Completion
2023-03-31

Countries

  • United Kingdom

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05367284 on ClinicalTrials.gov