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

English version

Autoři: Jennifer S. Walsh ^aff001; Helen Marshall ^aff002; Isabelle L. Smith ^aff002; Diana M. Greenfield ^aff003; Jayne Swain ^aff002; Emma Best ^aff002; James Ashton ^aff004; Julia M. Brown ^aff002; Robert Huddart ^aff005; Robert E. Coleman ^aff001; John A. Snowden ^aff006; Richard J. Ross ^aff001
Působiště autorů: Department of Oncology and Metabolism, University of Sheffield, Sheffield, United Kingdom ^aff001; Clinical Trials Research Unit, University of Leeds, Leeds, United Kingdom ^aff002; Specialised Cancer Services, Sheffield Teaching Hospitals NHS Foundation Trust, Sheffield, United Kingdom ^aff003; TRYMS Trial Management Group, Sheffield, United Kingdom ^aff004; Institute for Cancer Research, London, United Kingdom ^aff005; Department of Haematology, Sheffield Teaching Hospitals NHS Foundation Trust, Sheffield, United Kingdom ^aff006
Vyšlo v časopise: Testosterone replacement in young male cancer survivors: A 6-month double-blind randomised placebo-controlled trial. PLoS Med 16(11): e1002960. doi:10.1371/journal.pmed.1002960
Kategorie: Research Article
doi: https://doi.org/10.1371/journal.pmed.1002960

Souhrn

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 (7–12 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 25–50 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.

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.

Klíčová slova:

Adverse events – Cancer treatment – Fatigue – Fats – Lymphomas – Testosterone – Testicular cancer

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