Status:
UNKNOWN
Perioperative Testosterone Replacement Therapy in Sarcopenic Male Colorectal Cancer Patients
Lead Sponsor:
London North West Healthcare NHS Trust
Conditions:
Colorectal Cancer
Sarcopenia
Eligibility:
MALE
45+ years
Brief 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) le...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
January 15 2022
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
March 1 2023
Estimated Enrollment :
30 Patients enrolled
Trial Details
Trial ID
NCT05367284
Start Date
January 15 2022
End Date
March 1 2023
Last Update
May 10 2022
Active Locations (1)
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1
London North West University Healthcare NHS Trust
London, United Kingdom