Colorectal CancerTERESANCT05367284
Perioperative Testosterone Replacement Therapy in Sarcopenic Male Colorectal Cancer Patients
An observational study of Colorectal Cancer and Sarcopenia, run by London North West Healthcare NHS Trust at 1 site in United Kingdom.
Trial 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. Read more about this study
- Who is it for?
- Ages 45 years and older, men only
- Conditions the study is for
- Colorectal Cancer, Sarcopenia, Hypogonadism, Male
- What is being tested?
- Testosterone
- How many people
- 30 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 15 Jan 2022to Mar 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 45 years and older
- Men only
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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
Show all 10Show fewer
- 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
Who cannot join
- 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)
Show all 19Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site, 1 recruiting
- Recruiting
London North West University Healthcare NHS Trust
London
I Drami, MSc, MRCS
I Drami, MSc, MRCS
About this study
Official title: Use of Perioperative Testosterone Replacement Therapy (TRT) in Sarcopenic Male Colorectal Cancer Patients - A Single Arm Open Label Feasibility Study
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
- Being tested
- Testosterone
- Medical subject headings
- Colorectal Neoplasms, Sarcopenia, Eunuchism
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TestosteroneDrug
Testogel 16.2 miligrams/ gram (mg/g) gel
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
Measured: 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
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 May 2022
- Study start15 Jan 2022
- Primary completionMar 2023 (estimated)
- Study completionMar 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (27)Papers the sponsor has linked to this study.
- Other trials for Colorectal CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- London North West Healthcare NHS Trust
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- JT Jenkins, MD, FRCS, Principal investigator, London North West University Hospital Healthcare NHS Trust
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05367284
- Sponsor's protocol ID
- RD21/025
- Acronym
- TERESA
- Status last verified
- Oct 2021
- First submitted
- 20 Jan 2022
- Last updated
- 10 May 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Mourtzakis 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.
PubMed 18923576Mullie 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.
PubMed 30744586Bozzetti 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.
PubMed 28911059Cruz-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.
PubMed 30312372Trejo-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.
PubMed 33481108Lee 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.
PubMed 32483936Pring 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.
PubMed 30321741Herbst KL, Bhasin S. Testosterone action on skeletal muscle. Curr Opin Clin Nutr Metab Care. 2004 May;7(3):271-7. doi: 10.1097/00075197-200405000-00006.
PubMed 15075918Burney BO, Garcia JM. Hypogonadism in male cancer patients. J Cachexia Sarcopenia Muscle. 2012 Sep;3(3):149-55. doi: 10.1007/s13539-012-0065-7. Epub 2012 Apr 20.
PubMed 22528986Harman SM, Metter EJ, Tobin JD, Pearson J, Blackman MR; Baltimore Longitudinal Study of Aging. Longitudinal effects of aging on serum total and free testosterone levels in healthy men. Baltimore Longitudinal Study of Aging. J Clin Endocrinol Metab. 2001 Feb;86(2):724-31. doi: 10.1210/jcem.86.2.7219.
PubMed 11158037Feldman HA, Longcope C, Derby CA, Johannes CB, Araujo AB, Coviello AD, Bremner WJ, McKinlay JB. Age trends in the level of serum testosterone and other hormones in middle-aged men: longitudinal results from the Massachusetts male aging study. J Clin Endocrinol Metab. 2002 Feb;87(2):589-98. doi: 10.1210/jcem.87.2.8201.
PubMed 11836290Slattery ML, Sweeney C, Murtaugh M, Ma KN, Wolff RK, Potter JD, Caan BJ, Samowitz W. Associations between ERalpha, ERbeta, and AR genotypes and colon and rectal cancer. Cancer Epidemiol Biomarkers Prev. 2005 Dec;14(12):2936-42. doi: 10.1158/1055-9965.EPI-05-0514.
PubMed 16365013Lu Y, Ljung R, Martling A, Lindblad M. Risk of Colorectal Cancer by Subsite in a Swedish Prostate Cancer Cohort. Cancer Control. 2015 Apr;22(2):263-70. doi: 10.1177/107327481502200222.
PubMed 26068776Gillessen S, Templeton A, Marra G, Kuo YF, Valtorta E, Shahinian VB. Risk of colorectal cancer in men on long-term androgen deprivation therapy for prostate cancer. J Natl Cancer Inst. 2010 Dec 1;102(23):1760-70. doi: 10.1093/jnci/djq419. Epub 2010 Nov 10.
PubMed 21068432Sah BK, Chen MM, Peng YB, Feng XJ, Yan M, Liu BY, Fan QS, Zhu ZG. Does testosterone prevent early postoperative complications after gastrointestinal surgery? World J Gastroenterol. 2009 Nov 28;15(44):5604-9. doi: 10.3748/wjg.15.5604.
PubMed 19938202
Study at a glance
From the registry record, last updated by the sponsor on 10 May 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Use of Perioperative Testosterone Replacement Therapy (TRT) in Sarcopenic Male Colorectal Cancer Patients - A Single Arm Open Label Feasibility Study
- ClinicalTrials.gov ID
- NCT05367284
- Acronym / sponsor ID
- TERESA / RD21/025
- Conditions
- Colorectal Cancer, Sarcopenia, Hypogonadism, Male, Perioperative Care, Testosterone Replacement Therapy
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- London North West Healthcare NHS TrustUniversity, hospital or other
- Study start
- 15 Jan 2022 (actual)
- Primary completion
- Mar 2023 (estimated)
- Study completion
- Mar 2023 (estimated)
- First posted
- 10 May 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 45 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (10 listed)
- 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
Key exclusion criteria (19 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| TestosteroneTestogel 16.2 miligrams/ gram (mg/g) gel | Drug | – |
Primary outcome
Number of days required for a patient to be recruited on the study and how many patients are recruited
Time frame: 1 year
number of days required for patients to be recruited and number of patients recruited by the closure of the study
Number of patients who will complete the 12 week treatment
Time frame: 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
Treatment acceptability questionnaire
Time frame: 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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 May 2022.
- Background: PubMed 18923576Mourtzakis 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.
- Background: PubMed 30744586Mullie 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.
- Background: PubMed 28911059Bozzetti 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.
- Background: PubMed 30312372Cruz-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.
- Background: PubMed 33481108Trejo-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.
- Background: PubMed 32483936Lee 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.
- Background: PubMed 30321741Pring 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.
- Background: PubMed 15075918Herbst KL, Bhasin S. Testosterone action on skeletal muscle. Curr Opin Clin Nutr Metab Care. 2004 May;7(3):271-7. doi: 10.1097/00075197-200405000-00006.
- Background: PubMed 22528986Burney BO, Garcia JM. Hypogonadism in male cancer patients. J Cachexia Sarcopenia Muscle. 2012 Sep;3(3):149-55. doi: 10.1007/s13539-012-0065-7. Epub 2012 Apr 20.
- Background: PubMed 11158037Harman SM, Metter EJ, Tobin JD, Pearson J, Blackman MR; Baltimore Longitudinal Study of Aging. Longitudinal effects of aging on serum total and free testosterone levels in healthy men. Baltimore Longitudinal Study of Aging. J Clin Endocrinol Metab. 2001 Feb;86(2):724-31. doi: 10.1210/jcem.86.2.7219.
- Background: PubMed 11836290Feldman HA, Longcope C, Derby CA, Johannes CB, Araujo AB, Coviello AD, Bremner WJ, McKinlay JB. Age trends in the level of serum testosterone and other hormones in middle-aged men: longitudinal results from the Massachusetts male aging study. J Clin Endocrinol Metab. 2002 Feb;87(2):589-98. doi: 10.1210/jcem.87.2.8201.
- Background: PubMed 16365013Slattery ML, Sweeney C, Murtaugh M, Ma KN, Wolff RK, Potter JD, Caan BJ, Samowitz W. Associations between ERalpha, ERbeta, and AR genotypes and colon and rectal cancer. Cancer Epidemiol Biomarkers Prev. 2005 Dec;14(12):2936-42. doi: 10.1158/1055-9965.EPI-05-0514.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
JT Jenkins, MD, FRCS principal investigator
London North West University Hospital Healthcare NHS Trust
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Colorectal Cancer and Sarcopenia, run by London North West Healthcare NHS Trust at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 19 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 10 May 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Ioanna Drami, MSc, MRCS (+4420 8864 3232, i.drami20@imperial.ac.uk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of days required for a patient to be recruited on the study and how many patients are recruited (time frame: 1 year). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05367284, which also lists 27 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 May 2022.