Clincosm LogoSign in Get a demo

TERESA: Perioperative Testosterone Replacement Therapy in Sarcopenic Male Colorectal Cancer Patients

Sponsor
London North West Healthcare NHS Trust (Other)
Overall Status
Recruiting
CT.gov ID
NCT05367284
Collaborator
(none)
30
Enrollment
1
Location
13.5
Anticipated Duration (Months)
2.2
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase

Study Design

Study Type:
Observational
Anticipated Enrollment :
30 participants
Observational Model:
Cohort
Time Perspective:
Prospective
Official Title:
Use of Perioperative Testosterone Replacement Therapy (TRT) in Sarcopenic Male Colorectal Cancer Patients - A Single Arm Open Label Feasibility Study
Actual Study Start Date :
Jan 15, 2022
Anticipated Primary Completion Date :
Mar 1, 2023
Anticipated Study Completion Date :
Mar 1, 2023

Outcome Measures

Primary Outcome Measures

  1. Number of days required for a patient to be recruited on the study and how many patients are recruited [1 year]

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

  2. Number of patients who will complete the 12 week treatment [12 weeks]

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

  3. Treatment acceptability questionnaire [12 weeks]

    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

Eligibility Criteria

Criteria

Ages Eligible for Study:
45 Years and Older
Sexes Eligible for Study:
Male
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 London North West University Healthcare NHS Trust London United Kingdom

Sponsors and Collaborators

  • London North West Healthcare NHS Trust

Investigators

  • Principal Investigator: JT Jenkins, MD, FRCS, London North West University Hospital Healthcare NHS Trust

Study Documents (Full-Text)

None provided.

More Information

Publications

Responsible Party:
London North West Healthcare NHS Trust
ClinicalTrials.gov Identifier:
NCT05367284
Other Study ID Numbers:
  • RD21/025
First Posted:
May 10, 2022
Last Update Posted:
May 10, 2022
Last Verified:
Oct 1, 2021
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:
Colorectal Neoplasms
Sarcopenia
Hypogonadism
Eunuchism
Testosterone

Study Results

No Results Posted as of May 10, 2022