Clinical trial · Observational
Perioperative Testosterone Replacement Therapy in Sarcopenic Male Colorectal Cancer Patients
Use of Perioperative Testosterone Replacement Therapy (TRT) in Sarcopenic Male Colorectal Cancer Patients - A Single Arm Open Label Feasibility Study
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (5)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Colorectal Cancer | Malignant Colorectal Neoplasm | CURATED_BROADER | 0.80 |
| Hypogonadism, Male | — | UNRESOLVED | — |
| Perioperative Care | — | UNRESOLVED | — |
| Sarcopenia | — | UNRESOLVED | — |
| Testosterone Replacement Therapy | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Testosterone | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (3)
- measure
- Number of days required for a patient to be recruited on the study and how many patients are recruited
- timeFrame
- 1 year
- description
- number of days required for patients to be recruited and number of patients recruited by the closure of the study
- measure
- Number of patients who will complete the 12 week treatment
- timeFrame
- 12 weeks
- description
- retention of the patients for a the total of 12 weeks by the time of recruitment, will be measured in days on study
- measure
- Treatment acceptability questionnaire
- timeFrame
- 12 weeks
- description
- 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
Eligibility (as posted)
- Sex
- Male
- Minimum age
- 45 Years
Show eligibility criteria text
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
References
Publications (27)
- BACKGROUNDMourtzakis M, Prado CM, Lieffers JR, Reiman T, McCargar LJ, Baracos VE. A practical and precise approach to quantification of body composition in cancer patients using computed tomography images acquired during routine care. Appl Physiol Nutr Metab. 2008 Oct;33(5):997-1006. doi: 10.1139/H08-075. PMID 18923576
- BACKGROUNDMullie L, Afilalo J. CoreSlicer: a web toolkit for analytic morphomics. BMC Med Imaging. 2019 Feb 11;19(1):15. doi: 10.1186/s12880-019-0316-6. PMID 30744586
- BACKGROUNDBozzetti F. Forcing the vicious circle: sarcopenia increases toxicity, decreases response to chemotherapy and worsens with chemotherapy. Ann Oncol. 2017 Sep 1;28(9):2107-2118. doi: 10.1093/annonc/mdx271. PMID 28911059
- BACKGROUNDCruz-Jentoft AJ, Bahat G, Bauer J, Boirie Y, Bruyere O, Cederholm T, Cooper C, Landi F, Rolland Y, Sayer AA, Schneider SM, Sieber CC, Topinkova E, Vandewoude M, Visser M, Zamboni M; Writing Group for the European Working Group on Sarcopenia in Older People 2 (EWGSOP2), and the Extended Group for EWGSOP2. Sarcopenia: revised European consensus on definition and diagnosis. Age Ageing. 2019 Jan 1;48(1):16-31. doi: 10.1093/ageing/afy169. PMID 30312372
- BACKGROUNDTrejo-Avila M, Bozada-Gutierrez K, Valenzuela-Salazar C, Herrera-Esquivel J, Moreno-Portillo M. Sarcopenia predicts worse postoperative outcomes and decreased survival rates in patients with colorectal cancer: a systematic review and meta-analysis. Int J Colorectal Dis. 2021 Jun;36(6):1077-1096. doi: 10.1007/s00384-021-03839-4. Epub 2021 Jan 22. PMID 33481108
- BACKGROUNDLee CM, Kang J. Prognostic impact of myosteatosis in patients with colorectal cancer: a systematic review and meta-analysis. J Cachexia Sarcopenia Muscle. 2020 Oct;11(5):1270-1282. doi: 10.1002/jcsm.12575. Epub 2020 Jun 1. PMID 32483936
- Pring ET, Malietzis G, Kennedy RH, Athanasiou T, Jenkins JT. Cancer cachexia and myopenia - Update on management strategies and the direction of future research for optimizing body composition in cancer - A narrative review. Cancer Treat Rev. 2018 Nov;70:245-254. doi: 10.1016/j.ctrv.2018.10.002. Epub 2018 Oct 6.