Abstract
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.
Highlights
The number of young cancers survivors is ever increasing, and by the year 2020, it is estimated that there will be half a million survivors of childhood cancer residing in the United States [1]
In young male cancer survivors with low-normal morning total serum testosterone, replacement with testosterone is associated with an improvement in body composition
A total of 136 men aged 25–50 years were recruited between 17 July 2012 and 17 February 2015 (Consolidated Standards of Reporting Trials [CONSORT] diagram Fig 1)
Summary
The number of young cancers survivors is ever increasing, and by the year 2020, it is estimated that there will be half a million survivors of childhood cancer residing in the United States [1]. A consequence of this is the emergence of long-term sequelae, late effects, the most common of which are endocrine disorders that affect up to 50% of adult childhood cancer survivors [2, 3]. Cross-sectional data show that 27% of young male cancer survivors 25–45 years old have a serum testosterone concentration below the 10th centile of matched controls [7], associated with increased trunk fat mass and worse quality of life (QoL) than matched controls [7, 8]. Young male cancer survivors have lower testosterone levels, higher fat mass, and worse quality of life (QoL) than age-matched healthy controls. 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)
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