%0 Journal Article
%T Testosterone replacement in young male cancer survivors: A 6-month double-blind randomised placebo-controlled trial
%A Diana M. Greenfield
%A Emma Best
%A Helen Marshall
%A Isabelle L. Smith
%A James Ashton
%A Jayne Swain
%A Jennifer S. Walsh
%A John A. Snowden
%A Julia M. Brown
%A Richard J. Ross
%A Robert E. Coleman
%A Robert Huddart
%J -
%D 2019
%R 10.1371/journal.pmed.1002960
%X Background 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每12 nmol/l).   Methods and findings This was a multicentre United Kingdom study conducted in secondary care hospital outpatients. Male survivors of testicular cancer, lymphoma, and leukaemia aged 25每50 years with morning total serum testosterone 7每12 nmol/l were recruited. A total of 136 men were randomised between July 2012 and February 2015 (42.6% aged 25每37 years, 57.4% 38每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 (ˋ0.9 kg, 95% CI ˋ1.6 to ˋ0.3, p = 0.0073), decreased whole-body fat mass (ˋ1.8 kg, 95% CI ˋ2.9 to ˋ0.7, p = 0.0016), and increased lean body mass (1.5 kg, 95% CI 0.9每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.   Conclusions In young male cancer survivors with low-normal morning total serum testosterone, replacement with testosterone is associated with an improvement in body composition.   Trial registration ISRCTN: 70274195, EudraCT: 2011-000677-31
%K Testosterone
%K Fats
%K Cancer treatment
%K Adverse events
%K Fatigue
%K Lymphomas
%K Bone density
%K Testicular cancer
%U https://journals.plos.org/plosmedicine/article?id=10.1371/journal.pmed.1002960