Evidence map›Paper›PMID 31391011›Full record

Trial reportBMC cancer2019

Effects of adjunct testosterone on cardiac morphology and function in advanced cancers: an ancillary analysis of a randomized controlled trial.

Jessica M Scott, E Lichar Dillon, Michael Kinsky, Albert Chamberlain, Susan McCammon, Daniel Jupiter, Maurice Willis, Sandra Hatch, Gwyn Richardson, Christopher Danesi and 5 more

Registry-linked trialOpen access · goldAbstract readRandomized Controlled Trial
PubMed Full text at PMC Publisher
In one paragraph

Trial report in BMC cancer, 2019. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT00878995 (Nutrition and Anabolic Interventions in Squamous Cell Carcinoma), which is not on this map. Cited by 5 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
5citing papers in PubMed, 1 pooled it
0.6field-weighted citation impact, top 28% 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.

NCT00878995 phase1completednot on this map

Nutrition and Anabolic Interventions in Squamous Cell Carcinoma

TypeinterventionalSponsorThe University of Texas Medical Branch, GalvestonRan2009 to 2015Enrolled28ConditionsCachexia, Squamous Cell CarcinomaArmsPlacebo Testosterone, Testosterone Enanthate 100 MG/ML
3 · Its place in the literature

Who cites it

5 citing papers in PubMed, 1 synthesis or guideline pooled it, 10 citations in OpenAlex.

  1. Pooled it
  2. Article
  3. Review
  4. Article
  5. Review
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

15 authors at 3 institutions in 1 country.

Jessica M ScottDepartment of Medicine, Memorial Sloan Kettering Cancer Center, New York, NY, USA.
E Lichar DillonDepartment of Internal Medicine, The University of Texas Medical Branch, Galveston, TX, USA.
Michael KinskyDepartment of Anesthesiology, The University of Texas Medical Branch, Galveston, TX, USA.
Albert ChamberlainDepartment of Internal Medicine, The University of Texas Medical Branch, Galveston, TX, USA.
Susan McCammonDepartment of Otolaryngology, The University of Texas Medical Branch, Galveston, TX, USA.
Daniel JupiterDepartment of Preventive Medicine and Community Health, The University of Texas Medical Branch, Galveston, TX, USA.
Maurice WillisDepartment of Internal Medicine, The University of Texas Medical Branch, Galveston, TX, USA.
Sandra HatchDepartment of Radiation Oncology, The University of Texas Medical Branch, Galveston, TX, USA.
Gwyn RichardsonDepartment of Gynecologic Oncology, The University of Texas Medical Branch, Galveston, TX, USA.
Christopher DanesiDepartment of Internal Medicine, The University of Texas Medical Branch, Galveston, TX, USA.
Kathleen RandolphDepartment of Internal Medicine, The University of Texas Medical Branch, Galveston, TX, USA.
William DurhamDepartment of Internal Medicine, The University of Texas Medical Branch, Galveston, TX, USA.
Traver WrightDepartment of Internal Medicine, The University of Texas Medical Branch, Galveston, TX, USA.
Randall UrbanDepartment of Internal Medicine, The University of Texas Medical Branch, Galveston, TX, USA.
Melinda Sheffield-MooreDepartment of Internal Medicine, The University of Texas Medical Branch, Galveston, TX, USA. msheffield-moore@tamu.edu.ORCID http://orcid.org/0000-0001-6579-4655
The University of Texas Medical Branch at Galveston · USMemorial Sloan Kettering Cancer Center · USTexas A&M University System · US

Funding

X-RAY CRYSTALLOGRAPHYP30CA008748 · NCI · SLOAN-KETTERING INSTITUTE FOR CANCER RES · PI Hongbiao Carl Lekaye · 1985 to 2026
$347.4M
UTMB Clinical and Translational Science AwardUL1TR000071 · NCATS · UNIVERSITY OF TEXAS MED BR GALVESTON · PI BRASIER, ALLAN R. · 2012 to 2014
$14.4M
Nutrition and Anabolic Interventions in Cancer CachexiaR01CA127971 · NCI · UNIVERSITY OF TEXAS MED BR GALVESTON · PI SHEFFIELD-MOORE, MELINDA · 2008 to 2014
$1.8M
NCATS NIH HHS UL1 TR000071NCI NIH HHS P30 CA008748NCI NIH HHS R01 CA127971NCI NIH HHS R01CA127971
6 · The paper itself

Abstract

backgroundAdjunct testosterone therapy improves lean body mass, quality of life, and physical activity in patients with advanced cancers; however, the effects of testosterone on cardiac morphology and function are unknown. Accordingly, as an ancillary analysis of a randomized, placebo-controlled trial investigating the efficacy of testosterone supplementation on body composition in men and women with advanced cancers, we explored whether testosterone supplementation could prevent or reverse left ventricular (LV) atrophy and dysfunction.

methodsMen and women recently diagnosed with late stage (≥IIB) or recurrent head and neck or cervical cancer who were scheduled to receive standard of care chemotherapy or concurrent chemoradiation were administered an adjunct 7 week treatment of weekly intramuscular injections of either 100 mg testosterone (T, n = 1 M/5F) or placebo (P, n = 6 M/4F) in a double-blinded randomized fashion. LV morphology (wall thickness), systolic function (ejection fraction, EF), diastolic function (E/A; E'/E), arterial elastance (Ea), end-systolic elastance (Ees), and ventricular-arterial coupling (Ea/Ees) were assessed.

resultsNo significant differences were observed in LV posterior wall thickness in placebo (pre: 1.10 ± 0.1 cm; post: 1.16 ± 0.2 cm; p = 0.11) or testosterone groups (pre: 0.99 ± 0.1 cm; post: 1.14 ± 0.20 cm; p = 0.22). Compared with placebo, testosterone significantly improved LVEF (placebo: - 1.8 ± 4.3%; testosterone: + 6.2 ± 4.3%; p < 0.05), Ea (placebo: 0.0 ± 0.2 mmHg/mL; testosterone: - 0.3 ± 0.2 mmHg/mL; p < 0.05), and Ea/Ees (placebo: 0.0 ± 0.1; testosterone: - 0.2 ± 0.1; p < 0.05).

conclusionsIn patients with advanced cancers, testosterone was associated with favorable changes in left ventricular systolic function, arterial elastance, and ventricular-arterial coupling. Given the small sample size, the promising multisystem benefits of testosterone warrants further evaluation in a definitive randomized trial.

trial registrationThis study was prospectively registered on ClinicalTrials.gov (NCT00878995; date of registration: April 9, 2009).

Indexed as

AdultAntineoplastic Combined Chemotherapy ProtocolsBlood PressureEchocardiographyFemaleHeartHeart FailureHeart RateHeart VentriclesHumansMaleMiddle AgedNeoplasmsQuality of LifeTestosteroneTreatment OutcomeTestosteroneCachexiaCardiac functionTestosterone

Identifiers

PMID31391011
PMCPMC6686390
OpenAlexW2964786200

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.