Evidence map›Paper›PMID 32372176›Full record

Trial reportSupportive care in cancer : official journal of the Multinational Association of Supportive Care in Cancer2021

A randomized, double-blind, placebo-controlled trial of testosterone for treatment of postmenopausal women with aromatase inhibitor-induced arthralgias: Alliance study A221102.

Elizabeth Cathcart-Rake, Paul Novotny, Roberto Leon-Ferre, Jennifer Le-Rademacher, Elizabeth M Storrick, Araba A Adjei, Shelby Terstriep, Rebecca Glaser, Armando Giuliano, William R Mitchell and 7 more

Registry-linked trialOpen access · greenAbstract readRandomized Controlled Trial
In one paragraph

Trial report in Supportive care in cancer : official journal of the Multinational Association of Supportive Care in Cancer, 2021. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT01573442 (Randomized Double-Blind Placebo Controlled Study of Testosterone in the Adjuvant Treatment of Postmenopausal Women With Aromatase Inhibitor Induced Arthralgias), which is not on this map. Cited by 11 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
11citing papers in PubMed, 1 pooled it
0.9field-weighted citation impact, top 23% 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.

NCT01573442 phase3completednot on this map

Randomized Double-Blind Placebo Controlled Study of Testosterone in the Adjuvant Treatment of Postmenopausal Women With Aromatase Inhibitor Induced Arthralgias

TypeinterventionalSponsorAlliance for Clinical Trials in OncologyRan2013 to 2019Enrolled227ConditionsArthralgia, Breast Cancer, Hot Flashes, Musculoskeletal ComplicationsArmstestosterone, placebo
3 · Its place in the literature

Who cites it

11 citing papers in PubMed, 1 synthesis or guideline pooled it, 13 citations in OpenAlex.

  1. Pooled it
  2. Trial
  3. Trial
  4. Article
  5. Review
  6. Review
  7. Article
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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

17 authors at 9 institutions in 1 country.

Elizabeth Cathcart-RakeMayo Clinic, Rochester, MN, USA.
Paul NovotnyAlliance Statistics and Data Center, Mayo Clinic, Rochester, MN, USA.
Roberto Leon-FerreMayo Clinic, Rochester, MN, USA.
Jennifer Le-RademacherAlliance Statistics and Data Center, Mayo Clinic, Rochester, MN, USA.
Elizabeth M StorrickAlliance Statistics and Data Center, Mayo Clinic, Rochester, MN, USA.
Araba A AdjeiMayo Clinic, Rochester, MN, USA.
Shelby TerstriepSanford NCORP of the North Central Plains, Sioux Falls, SD, USA.
Rebecca GlaserWright State University Boonshoft School of Medicine, Dayton, OH, USA.
Armando GiulianoCedars-Sinai Medical Center, Los Angeles, CA, USA.
William R MitchellSoutheast Clinical Oncology Research Consortium NCORP, Winston-Salem, NC, USA.
Seth PageWichita NCI Community Oncology Research Program, Wichita, KS, USA.
Colleen AustinNorthside Hospital, Atlanta, GA, USA.
Richard L DemingMercy Medical Center, Des Moines, IA, USA.
Margaret A FerreiraNorthside Hospital, Atlanta, GA, USA.
Jacqueline M LafkyMayo Clinic, Rochester, MN, USA.
Stephen N BirrellThe Breast and Endocrine Centre, Toorak Gardens, South Australia, Australia.
Charles L LoprinziMayo Clinic, Rochester, MN, USA. cloprinzi@mayo.edu.
Mayo Clinic in Arizona · USMayo Clinic · USNorthside Hospital · USAlliance Data (United States) · USCedars-Sinai Medical Center · USMercy Medical Center · USNorth Central College · USSoutheast Clinical Oncology Research Consortium · USWright State University · US

Funding

NRG Oncology Network Group Operations Center - GY9 BIQSFP Reports/BudgetsU10CA180868 · NCI · NRG ONCOLOGY FOUNDATION, INC. · PI NORMAN WOLMARK · 2014 to 2026
$206.8M
ECOG-ACRIN NCORP Research Base - TMISTUG1CA189828 · NCI · ECOG-ACRIN MEDICAL RESEARCH FOUNDATION · PI Peter J ODwyer, MITCHELL D. SCHNALL · 2014 to 2026
$199.7M
Project-006U10CA180820 · NCI · ECOG-ACRIN MEDICAL RESEARCH FOUNDATION · PI Peter J ODwyer · 2014 to 2026
$167.6M
Women's Cancer ProgramP30CA015083 · NCI · MAYO CLINIC ROCHESTER · PI AKHILESH PANDEY · 1985 to 2026
$151.3M
Collaborations and NCORP Collective ManagementUG1CA189823 · NCI · MAYO CLINIC ROCHESTER · PI Evanthia Galanis, Olwen Hahn · 2014 to 2026
$120.6M
Southeast Clinical Oncology Research Consortium, Inc. (SCOR)UG1CA189858 · NCI · SOUTHEAST CLINICAL ONCOL RES CONSORTIUM · PI Judith O Hopkins, William J Irvin · 2014 to 2026
$38.8M
THE ALLIANCE NCTN BIOREPOSITORY AND BIOSPECIMEN RESOURCEU24CA196171 · NCI · WASHINGTON UNIVERSITY · PI Mine Cicek, Wendy Frankel · 2015 to 2026
$35.0M
ZESTRIL VS. VERAPAMIL IN THE TREATMENT OF HYPERTENSIONM01RR000585 · NCRR · MAYO CLINIC ROCHESTER · PI RIZZA, ROBERT A. · 1985 to 2006
$30.4M
Georgia NCI Community Oncology Research Program (NCORP)UG1CA189997 · NCI · NORTHSIDE HOSPITAL ATLANTA · PI Guilherme Cantuaria, Leonard R. Henry · 2014 to 2026
$20.9M
Carle Cancer Center NCI Community Oncology Research Progran (NCORP)UG1CA189861 · NCI · CARLE FOUNDATION · PI KENDRITH Martin ROWLAND · 2014 to 2026
$20.4M
Institutional Career Development CoreKL2TR002379 · NCATS · MAYO CLINIC ROCHESTER · PI NILUFER ERTEKIN-TANER · 2017 to 2026
$14.9M
WASHINGTON UNIVERSITY / SITEMAN CANCER CENTER LEAD ACADEMIC SITEUG1CA233339 · NCI · WASHINGTON UNIVERSITY · PI NANCY L BARTLETT, Clifford Grant Robinson · 2019 to 2026
$11.3M
NCATS NIH HHS KL2 TR002379NCI NIH HHS P30 CA015083NCI NIH HHS U10 CA180820NCI NIH HHS U10CA180820NCI NIH HHS U10 CA180868NCI NIH HHS U10CA180868NCI NIH HHS U24 CA196171NCI NIH HHS U24CA196171NCI NIH HHS UG1 CA189823NCI NIH HHS UG1CA189823NCI NIH HHS UG1 CA189828NCI NIH HHS UG1 CA189858NCI NIH HHS UG1CA189858NCI NIH HHS UG1 CA189861NCI NIH HHS UG1CA189861NCI NIH HHS UG1 CA189997NCI NIH HHS UG1CA189997NCI NIH HHS UG1 CA232760NCI NIH HHS UG1CA232760NCI NIH HHS UG1 CA233339NCRR NIH HHS M01 RR000585
6 · The paper itself

Abstract

purposeTo evaluate the efficacy of testosterone supplementation for improving aromatase inhibitor musculoskeletal symptoms (AIMSS).

methodsPostmenopausal women experiencing moderate-to-severe arthralgias while taking adjuvant aromatase inhibitors for breast cancer were enrolled in this trial. Initially, patients were randomly allocated to receive either a subcutaneous testosterone pellet versus a placebo pellet. Due to slow accrual, the protocol was modified such that additional participants were randomized to receive either a topical testosterone gel or a placebo gel. Changes in patient-reported joint pain were compared between patients receiving testosterone and those receiving placebo using a two-sample t test. Changes in hot flashes and other vasomotor symptoms were also analyzed. Further analyses were conducted to evaluate whether 27 single nucleotide polymorphisms (SNPs) in 14 genes previously associated with AIMSS were associated with testosterone supplementation benefit.

resultsWhile 64% of patients reported an improvement in joint pain at 3 months, there were no significant differences in average pain or joint stiffness at 3 or 6 months between testosterone and placebo arms. Patients receiving testosterone did report improvements in strength, lack of energy, urinary frequency, and stress incontinence (p < 0.05). The subset of patients receiving subcutaneous testosterone also experienced improvements in hot flashes and mood swings. An inherited variant (rs7984870 CC genotype) in TNFSF11 was more likely to be associated with improvements in hot flashes in patients receiving testosterone.

conclusionThe doses of testosterone supplementation used in this study did not significantly improve AIMSS.

trial registrationClinicalTrials.gov Identifier: NCT01573442.

Indexed as

Administration, TopicalAromatase InhibitorsArthralgiaBreast NeoplasmsDouble-Blind MethodFemaleHot FlashesHumansMiddle AgedMusculoskeletal PainPolymorphism, Single NucleotidePostmenopauseQuality of LifeRANK LigandTestosteroneTreatment OutcomeAromatase InhibitorsRANK LigandTestosteroneTNFSF11 protein, humanAromatase inhibitor musculoskeletal symptomsHot flashesTestosteroneToxicity of endocrine therapy

Identifiers

PMID32372176
PMCPMC7644633
OpenAlexW3023630809

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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.