Perioperative Testosterone Replacement Therapy in Sarcopenic Male Colorectal Cancer Patients

NCT05367284 | Unknown

• 1 other identifier: RD21/025
• Study Type: observational
• Target: 30
• Locations: 1 country
• Sites: 1

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) 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

Colorectal Cancer; Sarcopenia; Hypogonadism, Male; Perioperative Care; Testosterone Replacement Therapy

Outcome Measures

Primary Outcomes (3)

• Number of days required for a patient to be recruited on the study and how many patients are recruited

  number of days required for patients to be recruited and number of patients recruited by the closure of the study

  1 year

• Number of patients who will complete the 12 week treatment

  retention of the patients for a the total of 12 weeks by the time of recruitment, will be measured in days on study

  12 weeks

• Treatment acceptability questionnaire

  questionnaire on the difficulty experience (Likert scale) for the use of the gel for 12 weeks, if they developed any side effects as described on the CTCAE version 5.0

  12 weeks

Interventions

Testosterone DRUG

Testogel 16.2 miligrams/ gram (mg/g) gel

Eligibility Criteria

• Age: 45 Years+
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients diagnosed with colorectal cancer who attend to the surgical clinic, following completion of their neoadjuvant chemoradiotherapy or for initial review by the surgical team in order to proceed with surgery.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• London North West Healthcare NHS Trust: lead

Study Sites (1)

London North West University Healthcare NHS Trust

London, United Kingdom

RECRUITING

Related Publications (27)

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MeSH Terms

Conditions

Colorectal Neoplasms; Sarcopenia; Eunuchism

Interventions

Testosterone

Condition Hierarchy (Ancestors)

Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Rectal Diseases; Muscular Atrophy; Neuromuscular Manifestations; Neurologic Manifestations; Nervous System Diseases; Atrophy; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Hypogonadism; Gonadal Disorders; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Androstenols; Androstenes; Androstanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Testosterone Congeners; Gonadal Steroid Hormones; Gonadal Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists

Study Officials

• JT Jenkins, MD, FRCS

  London North West University Hospital Healthcare NHS Trust

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Ioanna Drami, MSc, MRCS

CONTACT

+4420 8864 3232; i.drami20@imperial.ac.uk

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 20, 2022
• First Posted: May 10, 2022
• Study Start: January 15, 2022
• Primary Completion: March 1, 2023
• Study Completion: March 1, 2023
• Last Updated: May 10, 2022

Record last verified: 2021-10

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)