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

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-cont...

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Bibliographic Details
Published in:PLoS medicine 2019-11, Vol.16 (11), p.e1002960
Main Authors: Walsh, Jennifer S, Marshall, Helen, Smith, Isabelle L, Greenfield, Diana M, Swain, Jayne, Best, Emma, Ashton, James, Brown, Julia M, Huddart, Robert, Coleman, Robert E, Snowden, John A, Ross, Richard J
Format: Article
Language:English
Subjects:
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
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Summary: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.
ISSN:1549-1676
1549-1277
1549-1676
DOI:10.1371/journal.pmed.1002960