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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.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Testosterone | Drug | Testogel 16.2 miligrams/ gram (mg/g) gel |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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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.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Ioanna Drami, MSc, MRCS | Contact | +4420 8864 3232 | i.drami20@imperial.ac.uk |
| Name | Affiliation | Role |
|---|---|---|
| JT Jenkins, MD, FRCS | London North West University Hospital Healthcare NHS Trust | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| London North West University Healthcare NHS Trust | Recruiting | London | United Kingdom |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 18923576 | Background | 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. | |
| 30744586 | Background |
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| ID | Term |
|---|---|
| D015179 | Colorectal Neoplasms |
| D055948 | Sarcopenia |
| D005058 | Eunuchism |
| ID | Term |
|---|---|
| D007414 | Intestinal Neoplasms |
| D005770 | Gastrointestinal Neoplasms |
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
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| ID | Term |
|---|---|
| D013739 | Testosterone |
| ID | Term |
|---|---|
| D000737 | Androstenols |
| D000736 | Androstenes |
| D000731 | Androstanes |
| D013256 | Steroids |
| D000072473 |
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| 16365013 | Background | Slattery 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. |
| 26068776 | Background | Lu 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. |
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| 19938202 | Background | Sah 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. |
| 8637535 | Background | Bhasin S, Storer TW, Berman N, Callegari C, Clevenger B, Phillips J, Bunnell TJ, Tricker R, Shirazi A, Casaburi R. The effects of supraphysiologic doses of testosterone on muscle size and strength in normal men. N Engl J Med. 1996 Jul 4;335(1):1-7. doi: 10.1056/NEJM199607043350101. |
| 29654645 | Background | Wright TJ, Dillon EL, Durham WJ, Chamberlain A, Randolph KM, Danesi C, Horstman AM, Gilkison CR, Willis M, Richardson G, Hatch SS, Jupiter DC, McCammon S, Urban RJ, Sheffield-Moore M. A randomized trial of adjunct testosterone for cancer-related muscle loss in men and women. J Cachexia Sarcopenia Muscle. 2018 Jun;9(3):482-496. doi: 10.1002/jcsm.12295. Epub 2018 Apr 14. |
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| 32773614 | Background | Wischmeyer PE, Suman OE, Kozar R, Wolf SE, Molinger J, Pastva AM. Role of anabolic testosterone agents and structured exercise to promote recovery in ICU survivors. Curr Opin Crit Care. 2020 Oct;26(5):508-515. doi: 10.1097/MCC.0000000000000757. |
| D009369 | Neoplasms |
| D004066 | Digestive System Diseases |
| D005767 | Gastrointestinal Diseases |
| D003108 | Colonic Diseases |
| D007410 | Intestinal Diseases |
| D012002 | Rectal Diseases |
| D009133 | Muscular Atrophy |
| D020879 | Neuromuscular Manifestations |
| D009461 | Neurologic Manifestations |
| D009422 | Nervous System Diseases |
| D001284 | Atrophy |
| D020763 | Pathological Conditions, Anatomical |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D012816 | Signs and Symptoms |
| D007006 | Hypogonadism |
| D006058 | Gonadal Disorders |
| D004700 | Endocrine System Diseases |
| Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |
| D045165 | Testosterone Congeners |
| D012739 | Gonadal Steroid Hormones |
| D042341 | Gonadal Hormones |
| D006728 | Hormones |
| D006730 | Hormones, Hormone Substitutes, and Hormone Antagonists |