Journal Article

Testosterone replacement in young male cancer survivors: A 6-month double-blind randomised placebo-controlled trial

Coleman, Robert E., Walsh, Jennifer S., Greenfield, Diana M., Best, Emma, Brown, Julia M., Ross, Richard J., Marshall, Helen, Smith, Isabelle L., Snowden, John A., Huddart, Robert, Ashton, James, Swain, Jayne

2019

Overview

Young male cancer survivors have lower testosterone levels, higher fat mass, and worse quality of life (QoL) than age-matched healthy controls. Low testosterone in cancer survivors can be due to orchidectomy or effects of chemotherapy and radiotherapy. We have undertaken a double-blind, placebo-controlled, 6-month trial of testosterone replacement in young male cancer survivors with borderline low testosterone (7-12 nmol/l). This was a multicentre United Kingdom study conducted in secondary care hospital outpatients. Male survivors of testicular cancer, lymphoma, and leukaemia aged 25-50 years with morning total serum testosterone 7-12 nmol/l were recruited. A total of 136 men were randomised between July 2012 and February 2015 (42.6% aged 25-37 years, 57.4% 38-50 years, 88% testicular cancer, 10% lymphoma, matched for body mass index [BMI]). Participants were randomised 1:1 to receive testosterone (Tostran 2% gel) or placebo for 26 weeks. A dose titration was performed after 2 weeks. The coprimary end points were trunk fat mass and SF36 Physical Functioning score (SF36-PF) at 26 weeks by intention to treat. At 26 weeks, testosterone treatment compared with placebo was associated with decreased trunk fat mass (-0.9 kg, 95% CI -1.6 to -0.3, p = 0.0073), decreased whole-body fat mass (-1.8 kg, 95% CI -2.9 to -0.7, p = 0.0016), and increased lean body mass (1.5 kg, 95% CI 0.9-2.1, p < 0.001). Decrease in fat mass was greatest in those with a high truncal fat mass at baseline. There was no treatment effect on SF36-PF or any other QoL scores. Testosterone treatment was well tolerated. The limitations of our study were as follows: a relatively short duration of treatment, only three cancer groups included, and no hard end point data such as cardiovascular events. In young male cancer survivors with low-normal morning total serum testosterone, replacement with testosterone is associated with an improvement in body composition. ISRCTN: 70274195, EudraCT: 2011-000677-31.

• Publisher: Public Library of Science,Public Library of Science (PLoS)
• Subject: Adipose Tissue - drug effects / Adult / Age / Biology and Life Sciences / Body composition / Body Composition - drug effects / Body fat / Body mass / Body mass index / Cancer / Cancer research / Cancer Survivors / Cancer treatment / Chemotherapy / Clinical trials / Double-Blind Method / Double-blind studies / Drug therapy / Humans / Laboratories / Lean body mass / Leukemia / Leukemia - complications / Lymphoma / Lymphoma - complications / Lymphomas / Male / Medical research / Medicine and Health Sciences / Metabolism / Middle Aged / Oncology / Orchidectomy / Placebo Effect / Quality of Life / Radiation therapy / Radiotherapy / Randomization / Research and Analysis Methods / Teaching hospitals / Testes / Testicular cancer / Testicular Neoplasms - complications / Testicular Neoplasms - drug therapy / Testosterone / Testosterone - pharmacology / Testosterone - therapeutic use / Titration / Tumors / United Kingdom