Skip to main content

COVID-19 Resources

What people with cancer should know: https://www.cancer.gov/coronavirus

Guidance for cancer researchers: https://www.cancer.gov/coronavirus-researchers

Get the latest public health information from CDC: https://www.cdc.gov/coronavirus

Get the latest research information from NIH: https://www.covid19.nih.gov

Grant Details

Grant Number: 5R01CA239208-02 Interpret this number
Primary Investigator: Garcia, Jose
Organization: Seattle Inst For Biomedical/Clinical Res
Project Title: Improving Patient-Important Outcomes with Testosterone Replacement in Hypogonadal Men with a Prior History of Cancer
Fiscal Year: 2020


Abstract

PROJECT SUMMARY/ABSTRACT The overall goal of this proposal is to evaluate the efficacy of testosterone replacement therapy in improving fatigue and other outcomes such as sexual function, quality of life, body composition, muscle strength and physical activity in a double-blind, randomized, placebo-controlled trial in young cancer survivors who report fatigue and have testosterone deficiency. Fatigue is one of the most prevalent and debilitating symptoms in men with cancer affecting 70-100% of patients irrespective of their age. Cancer-related fatigue is experienced by patients not only during active cancer treatment, but is also highly prevalent in cancer survivors who exhibit persistent fatigue months to years after the end of their treatment with the highest prevalence being in recipients of chemotherapy and/or radiation therapy. In addition to fatigue, sexual dysfunction is also highly prevalent in male cancer survivors. Male cancer survivors also have increased fat mass and decreased lean body mass, a phenotype that predisposes them to reduced muscle strength. This phenotype of fatigue, sexual dysfunction and adverse body composition is commonly encountered in non-cancer patient populations with testosterone deficiency, a condition which is also highly prevalent (50-90%) in cancer survivors. Pivotal trials of testosterone replacement therapy in non-cancer patient populations have shown an improvement in fatigue, sexual function and body composition in men randomized to testosterone compared with placebo. However, the efficacy of testosterone replacement therapy on cancer-related fatigue has not been studied. We propose a large, 9-month, double-blind, randomized, placebo-controlled trial in which: 1) we will compare the efficacy of weekly testosterone injections versus placebo in improving fatigue scores in cancer survivors who report fatigue and also have testosterone deficiency, 2) we will compare the effects of testosterone replacement versus placebo on sexual function, well-being, mood and quality of life, and 3) we will determine the effect of testosterone administration on body composition, muscle strength and physical activity compared with placebo. With an increase in longevity among cancer survivors and the growing recognition of the importance of symptom control in the lives of these patients, the proposed trial is likely to have a significant clinical impact in the management of patient-reported outcomes. If testosterone therapy is found to be efficacious in alleviating these symptoms, the clinicians will have available to them a therapeutic option that is relatively inexpensive, convenient to use and has a good safety record in young men.



Publications

Growth hormone secretagogue receptor-1a mediates ghrelin's effects on attenuating tumour-induced loss of muscle strength but not muscle mass.
Authors: Liu H. , Zang P. , Lee I.I. , Anderson B. , Christiani A. , Strait-Bodey L. , Breckheimer B.A. , Storie M. , Tewnion A. , Krumm K. , et al. .
Source: Journal of cachexia, sarcopenia and muscle, 2021 Oct; 12(5), p. 1280-1295.
EPub date: 2021-07-15.
PMID: 34264027
Related Citations

Experience of a Pituitary Clinic for US Military Veterans With Traumatic Brain Injury.
Authors: Lee J. , Anderson L.J. , Migula D. , Yuen K.C.J. , McPeak L. , Garcia J.M. .
Source: Journal of the Endocrine Society, 2021-04-01; 5(4), p. bvab005.
EPub date: 2021-01-25.
PMID: 33655093
Related Citations

Evaluation of physical function and its association with body composition, quality of life and biomarkers in cancer cachexia patients.
Authors: Anderson L.J. , Lee J. , Mallen M.C. , Migula D. , Liu H. , Wu P.C. , Dash A. , Garcia J.M. .
Source: Clinical nutrition (Edinburgh, Scotland), 2021 03; 40(3), p. 978-986.
EPub date: 2020-07-15.
PMID: 32713720
Related Citations

Effect of Body Weight and Other Metabolic Factors on Risk of Non-Small Cell Lung Cancer among Veterans with HIV and a History of Smoking.
Authors: Garcia J.M. , Kramer J.R. , Richardson P.A. , Ahmed S. , Royse K.E. , White D.L. , Raychaudhury S. , Chang E. , Hartman C.M. , Silverberg M.J. , et al. .
Source: Cancers, 2020-12-17; 12(12), .
EPub date: 2020-12-17.
PMID: 33348663
Related Citations

Ghrelin ameliorates tumor-induced adipose tissue atrophy and inflammation via Ghrelin receptor-dependent and -independent pathways.
Authors: Liu H. , Luo J. , Guillory B. , Chen J.A. , Zang P. , Yoeli J.K. , Hernandez Y. , Lee I.I. , Anderson B. , Storie M. , et al. .
Source: Oncotarget, 2020-09-01; 11(35), p. 3286-3302.
EPub date: 2020-09-01.
PMID: 32934774
Related Citations

Muscle mass, not radiodensity, predicts physical function in cancer patients with or without cachexia.
Authors: Anderson L.J. , Chong N. , Migula D. , Sauer A. , Garrison M. , Wu P. , Dash A. , Garcia J.M. .
Source: Oncotarget, 2020-05-19; 11(20), p. 1911-1921.
EPub date: 2020-05-19.
PMID: 32499874
Related Citations

Assessing Cachexia Acutely after Autologous Stem Cell Transplant.
Authors: Anderson L.J. , Yin C. , Burciaga R. , Lee J. , Crabtree S. , Migula D. , Geiss-Wessel K. , Liu H.M. , Graf S.A. , Chauncey T.R. , et al. .
Source: Cancers, 2019-09-04; 11(9), .
EPub date: 2019-09-04.
PMID: 31487803
Related Citations

Clinical research in older adults with hematologic malignancies: Opportunities for alignment in the Veterans Affairs.
Authors: Graf S.A. , Samples L.S. , Keating T.M. , Garcia J.M. .
Source: Seminars in oncology, 2019 Aug - Oct; 46(4-5), p. 341-345.
EPub date: 2019-10-01.
PMID: 31606147
Related Citations




Back to Top