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Grant Details

Grant Number: 5R01CA239208-04 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: 2023


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.


Metabolic and quality of life effects of growth hormone replacement in patients with TBI and AGHD: A pilot study.
Authors: Herodes M. , Le N. , Anderson L.J. , Migula D. , Miranda G. , Paulsen L. , Garcia J.M. .
Source: Growth hormone & IGF research : official journal of the Growth Hormone Research Society and the International IGF Research Society, 2023 Aug; 71, p. 101544.
EPub date: 2023-06-01.
PMID: 37295336
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A Review of Nutraceuticals in Cancer Cachexia.
Authors: Caeiro L. , Gandhay D. , Anderson L.J. , Garcia J.M. .
Source: Cancers, 2023-07-30; 15(15), .
EPub date: 2023-07-30.
PMID: 37568700
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EXT418, a novel long-acting ghrelin, mitigates Lewis lung carcinoma induced cachexia in mice.
Authors: Kerr H.L. , Krumm K. , Lee I.I. , Anderson B. , Christiani A. , Strait L. , Breckheimer B.A. , Irwin B. , Jiang A.S. , Rybachok A. , et al. .
Source: Journal of cachexia, sarcopenia and muscle, 2023 Jun; 14(3), p. 1337-1348.
EPub date: 2023-03-21.
PMID: 36942661
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Pilot clinical trial of macimorelin to assess safety and efficacy in patients with cancer cachexia.
Authors: Herodes M. , Anderson L.J. , Shober S. , Schur E.A. , Graf S.A. , Ammer N. , Salas R. , Marcelli M. , Garcia J.M. .
Source: Journal of cachexia, sarcopenia and muscle, 2023 Apr; 14(2), p. 835-846.
EPub date: 2023-03-01.
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Effect of HIV and antiretroviral therapy use on body weight changes in a cohort of U.S. veterans living with and without HIV.
Authors: Garcia J.M. , Dong Y. , Richardson P. , Kramer J.R. , Hartman C.M. , Royse K. , White D.L. , Chiao E.Y. .
Source: HIV medicine, 2023 Feb; 24(2), p. 180-190.
EPub date: 2022-08-05.
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Whole-body and adipose tissue metabolic phenotype in cancer patients.
Authors: Anderson L.J. , Lee J. , Anderson B. , Lee B. , Migula D. , Sauer A. , Chong N. , Liu H. , Wu P.C. , Dash A. , et al. .
Source: Journal of cachexia, sarcopenia and muscle, 2022 Apr; 13(2), p. 1124-1133.
EPub date: 2022-01-28.
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Androgens and estrogens predict sexual function after autologous hematopoietic stem cell transplant in men.
Authors: Anderson L.J. , Migula D. , Abay R. , Crabtree S. , Graf S.A. , Matsumoto A.M. , Chauncey T.R. , Garcia J.M. .
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The Management of Cancer Symptoms and Treatment-Induced Side Effects With Cannabis or Cannabinoids.
Authors: Sexton M. , Garcia J.M. , Jatoi A. , Clark C.S. , Wallace M.S. .
Source: Journal of the National Cancer Institute. Monographs, 2021-11-28; 2021(58), p. 86-98.
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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.
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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 Mar; 40(3), p. 978-986.
EPub date: 2020-07-15.
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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), .
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Ghrelin ameliorates tumor-induced adipose tissue atrophy and inflammation via Ghrelin receptor-dependent and -independent pathways.
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Muscle mass, not radiodensity, predicts physical function in cancer patients with or without cachexia.
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Assessing Cachexia Acutely after Autologous Stem Cell Transplant.
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