Perioperative Testosterone Replacement Therapy in Sarcopenic Male Colorectal Cancer Patients (TERESA)

  • STATUS
    Recruiting
  • End date
    Mar 25, 2023
  • participants needed
    30
  • sponsor
    London North West Healthcare NHS Trust
Updated on 25 May 2022
body mass index
cancer
fatigue
testosterone

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.

Details
Condition Colorectal Cancer, Sarcopenia, Hypogonadism, Male, Perioperative Care, Testosterone Replacement Therapy
Treatment testosterone
Clinical Study IdentifierNCT05367284
SponsorLondon North West Healthcare NHS Trust
Last Modified on25 May 2022

Eligibility

Yes No Not Sure

Inclusion Criteria

Male ≥ 45 years old
Colorectal cancer - histology confirmed
Identified as sarcopenic on latest computerised tomography (CT) scan prior to intervention (part of initial investigations - using Martin et al (2013) criteria - 43cm2/m2 for Body Mass Index (BMI) <25, 53cm2/m2 for BMI>25)
Documented low or normal testosterone at time of recruitment (<12 nano moles/ Litre (nmol/L)
Eligible for operative intervention
Capacity to consent
Able to mobilise & able to complete the 6 Minute Walk Test (MWT)
Post completion of chemotherapy/ chemoradiotherapy treatment (if the patient has neoadjuvant treatment)
Booked straight for surgery with an interim of 4-8 weeks
Participation in another concurrent trial/ study is accepted, following discussion between the two trial /study teams

Exclusion Criteria

Not sarcopenic on computerised tomography (CT)
Not eligible for surgery
History of Deep Vein Thrombosis (DVT)/ Pulmonary Embolism (PE)/ prostate cancer/ breast cancer
Prostate nodule identified during digital rectal examination (DRE) or magnetic resonance imaging (MRI) pelvis
Multiple distant metastasis which are non-operable
Prostate specific antigen (PSA) > 3 nanogram/ mililitre (ng/ml)
Haematocrit (HCT) >52%
Severe lower urinary tract symptoms
Class III/ IV heart failure
Myocardial Infarct or stroke within the last 6 months
Dementia / No capacity to consent
Patient on medications with anti-androgen effect eg spironolactone
Patients with untreated severe obstructive sleep apnoea
Morbid obesity as defined by Body Mass Index (BMI) >40
Uncontrolled hypertension
Patients on long term steroids during the trial period
Patient on other anabolic agents
Not already on treatment for primary hypogonadism
Patients with bone metastasis
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