Evidence map›Paper›PMID 31714912›Full record

Trial reportPLoS medicine2019

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

Jennifer S Walsh, Helen Marshall, Isabelle L Smith, Diana M Greenfield, Jayne Swain, Emma Best, James Ashton, Julia M Brown, Robert Huddart, Robert E Coleman and 2 more

Registry-linked trialOpen access · goldAbstract readMulticenter StudyRandomized Controlled Trial
In one paragraph

Trial report in PLoS medicine, 2019. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT05367284 (Use of Perioperative Testosterone Replacement Therapy), which is not on this map. Cited by 12 papers, 2 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
12citing papers in PubMed, 2 pooled it
2.1field-weighted citation impact, top 12% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT05367284 unknown statusnot on this mapstarted 2022, after this paper: background citation

Use of Perioperative Testosterone Replacement Therapy (TRT) in Sarcopenic Male Colorectal Cancer Patients - A Single Arm Open Label Feasibility Study

TypeobservationalSponsorLondon North West Healthcare NHS TrustRan2022 to 2023Enrolled30ConditionsColorectal Cancer, Sarcopenia, Hypogonadism, Male, Perioperative CareArmsTestosterone
3 · Its place in the literature

Who cites it

12 citing papers in PubMed, 2 syntheses or guidelines pooled it, 28 citations in OpenAlex.

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4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

12 authors at 3 institutions in 1 country.

Jennifer S WalshDepartment of Oncology and Metabolism, University of Sheffield, Sheffield, United Kingdom.ORCID 0000-0002-7122-2650
Helen MarshallClinical Trials Research Unit, University of Leeds, Leeds, United Kingdom.ORCID 0000-0003-0944-0152
Isabelle L SmithClinical Trials Research Unit, University of Leeds, Leeds, United Kingdom.ORCID 0000-0002-8326-1075
Diana M GreenfieldSpecialised Cancer Services, Sheffield Teaching Hospitals NHS Foundation Trust, Sheffield, United Kingdom.
Jayne SwainClinical Trials Research Unit, University of Leeds, Leeds, United Kingdom.
Emma BestClinical Trials Research Unit, University of Leeds, Leeds, United Kingdom.
James AshtonTRYMS Trial Management Group, Sheffield, United Kingdom.
Julia M BrownClinical Trials Research Unit, University of Leeds, Leeds, United Kingdom.
Robert HuddartInstitute for Cancer Research, London, United Kingdom.
Robert E ColemanDepartment of Oncology and Metabolism, University of Sheffield, Sheffield, United Kingdom.
John A SnowdenDepartment of Haematology, Sheffield Teaching Hospitals NHS Foundation Trust, Sheffield, United Kingdom.ORCID 0000-0001-6819-3476
Richard J RossDepartment of Oncology and Metabolism, University of Sheffield, Sheffield, United Kingdom.ORCID 0000-0001-9222-9678
University of Leeds · GBUniversity of Sheffield · GBSheffield Teaching Hospitals NHS Foundation Trust · GB

Funding

Cancer Research UK 11891Cancer Research UK 25447Cancer Research UK R/126349
6 · The paper itself

Abstract

backgroundYoung 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

findingsThis 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.

conclusionsIn young male cancer survivors with low-normal morning total serum testosterone, replacement with testosterone is associated with an improvement in body composition.

trial registrationISRCTN: 70274195, EudraCT: 2011-000677-31.

Indexed as

Adipose TissueAdultBody CompositionCancer SurvivorsDouble-Blind MethodHumansLeukemiaLymphomaMaleMiddle AgedPlacebo EffectQuality of LifeTesticular NeoplasmsTestosteroneUnited KingdomTestosterone

Identifiers

PMID31714912
PMCPMC6850530
OpenAlexW2984977265

What OpenQuestion holds

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LicenceCC BY
Read underepoch 390

Registered trials

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.