HoSAGE: Sarcopenia in older patient with intermediate / high-risk prostate cancer, prevalence and incidence after androgen deprivation therapy: Study protocol for a cohort trial
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Sarcopenia is defined by a loss of muscle strength associated to a decrease in skeletal muscle mass. Ageing greatly contributes to sarcopenia as may many other factors such as cancer or androgen deprivation thera‑ pies (ADT).
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HoSAGE: Sarcopenia in older patient with intermediate / high-risk prostate cancer, prevalence and incidence after androgen deprivation therapy: Study protocol for a cohort trialCoudercetal. BMC Cancer (2022) 22:78https://doi.org/10.1186/s12885-021-09105-8 STUDY PROTOCOL Open AccessHoSAGE: sarcopenia inolder patientwithintermediate / high-risk prostate cancer,prevalence andincidence afterandrogendeprivation therapy: study protocol foracohorttrialAnne‑LaureCouderc1,2,3* , PatrickVillani1,2,3, JulieBerbis4, EmilieNouguerède1,2, DominiqueRey1,2,DominiqueRossi5,7, ÉricLechevallier6,7, DelphineBadinand8, CyrilleBastide5,7, GillesKarsenty6,7,RomainBoissier6,7, KahenaAmichi9and XavierMuracciole8 Abstract Background: Sarcopenia is defined by a loss of muscle strength associated to a decrease in skeletal muscle mass. Ageing greatly contributes to sarcopenia as may many other factors such as cancer or androgen deprivation thera‑ pies (ADT). This cohort study aims to evaluate (1) the prevalence of muscle disorders and sarcopenia in older patients before initiation of intermediate to high risk prostate cancer treatment with ADT and radiotherapy, and (2) the occur‑ rence and/or aggravation of muscle disorders and sarcopenia at the end of cancer treatment. Methods: This cohort study is monocentric and prospective. The primary objectives are to determine the risk fac‑ tor of sarcopenia prevalence and to study the relationship between ADT and sarcopenia incidence, in patients 70 years and older with histologically proven localized or locally advanced prostate cancer, addressed to a geriatrician (G8 score ≤14) for comprehensive geriatric assessment (CGA) in Marseille University Hospital. Secondary objectives encompass, measurement of sarcopenia clinical criteria along prostate oncological treatment; evaluation of the quality of life of patients with sarcopenia; evaluation of the impact of socio-behavioral and anthropological factors on sarcopenia evolution and incidence; finally the evaluation of the impact of ADT exposure on sarcopenia. Sarcopenia prevalence was estimated to be between 20 and 30%, therefore the study will enroll 200 patients. Discussion: The current guidelines for older patients with prostate cancer recommend a pelvic radiotherapy treat‑ ment associated to variable duration (6 to 36 months) of ADT. However ADT impacts muscle mass and could exac‑ erbate the risks of sarcopenia. Our study intends to assess the specific effect of ADT on sarcopenia incidence and/or worsening as well as to estimate sarcopenia prevalence in this population. The results of this cohort trial will lead to a better understanding of sarcopenia prevalence and incidence necessary to further elaborate a prevention plan.*Correspondence: anne-laure.couderc@ap-hm.fr3 CNRS, EFS, ADES, Aix-Marseille University, 264 Rue Saint Pierre,13385Marseille, cedex 05, FranceFull list of author information is available at the end of the article © The Author(s) 2022. Open Access This article is licensed under a Creative Commons Attribution 4.0 International License, which permits use, sharing, adaptation, distribution and reproduction in any medium or format, as long as you give appropriate credit to the original author(s) and the source, provide a link to the Creative Commons licence, and indicate if changes were made. The images or other third party material in this article are included in the article’s Creative Commons licence, unless indicated otherwise in a credit line to the material. If material is not included in the article’s Creative Commons licence and your intended use is not permitted by statutory regulation or exceeds the permitted use, you will need to obtain permission directly from the copyright holder. To view a copy of this licence, visit http://creativecommons.org/licenses/by/4.0/. The Creative Commons Public Domain Dedication waiver (http://creativeco mmons.org/publicdomain/zero/1.0/) applies to the data made available in this article, unless otherwise stated in a credit line to the data.Coudercetal. BMC Cancer (2022) 22:78 Page 2 of 7 Trial registration: The protocol was registered to the French drug and device regulation agency under the number 2019-A02319-48, before beginning the study (11/12/2019 ...
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HoSAGE: Sarcopenia in older patient with intermediate / high-risk prostate cancer, prevalence and incidence after androgen deprivation therapy: Study protocol for a cohort trialCoudercetal. BMC Cancer (2022) 22:78https://doi.org/10.1186/s12885-021-09105-8 STUDY PROTOCOL Open AccessHoSAGE: sarcopenia inolder patientwithintermediate / high-risk prostate cancer,prevalence andincidence afterandrogendeprivation therapy: study protocol foracohorttrialAnne‑LaureCouderc1,2,3* , PatrickVillani1,2,3, JulieBerbis4, EmilieNouguerède1,2, DominiqueRey1,2,DominiqueRossi5,7, ÉricLechevallier6,7, DelphineBadinand8, CyrilleBastide5,7, GillesKarsenty6,7,RomainBoissier6,7, KahenaAmichi9and XavierMuracciole8 Abstract Background: Sarcopenia is defined by a loss of muscle strength associated to a decrease in skeletal muscle mass. Ageing greatly contributes to sarcopenia as may many other factors such as cancer or androgen deprivation thera‑ pies (ADT). This cohort study aims to evaluate (1) the prevalence of muscle disorders and sarcopenia in older patients before initiation of intermediate to high risk prostate cancer treatment with ADT and radiotherapy, and (2) the occur‑ rence and/or aggravation of muscle disorders and sarcopenia at the end of cancer treatment. Methods: This cohort study is monocentric and prospective. The primary objectives are to determine the risk fac‑ tor of sarcopenia prevalence and to study the relationship between ADT and sarcopenia incidence, in patients 70 years and older with histologically proven localized or locally advanced prostate cancer, addressed to a geriatrician (G8 score ≤14) for comprehensive geriatric assessment (CGA) in Marseille University Hospital. Secondary objectives encompass, measurement of sarcopenia clinical criteria along prostate oncological treatment; evaluation of the quality of life of patients with sarcopenia; evaluation of the impact of socio-behavioral and anthropological factors on sarcopenia evolution and incidence; finally the evaluation of the impact of ADT exposure on sarcopenia. Sarcopenia prevalence was estimated to be between 20 and 30%, therefore the study will enroll 200 patients. Discussion: The current guidelines for older patients with prostate cancer recommend a pelvic radiotherapy treat‑ ment associated to variable duration (6 to 36 months) of ADT. However ADT impacts muscle mass and could exac‑ erbate the risks of sarcopenia. Our study intends to assess the specific effect of ADT on sarcopenia incidence and/or worsening as well as to estimate sarcopenia prevalence in this population. The results of this cohort trial will lead to a better understanding of sarcopenia prevalence and incidence necessary to further elaborate a prevention plan.*Correspondence: anne-laure.couderc@ap-hm.fr3 CNRS, EFS, ADES, Aix-Marseille University, 264 Rue Saint Pierre,13385Marseille, cedex 05, FranceFull list of author information is available at the end of the article © The Author(s) 2022. Open Access This article is licensed under a Creative Commons Attribution 4.0 International License, which permits use, sharing, adaptation, distribution and reproduction in any medium or format, as long as you give appropriate credit to the original author(s) and the source, provide a link to the Creative Commons licence, and indicate if changes were made. The images or other third party material in this article are included in the article’s Creative Commons licence, unless indicated otherwise in a credit line to the material. If material is not included in the article’s Creative Commons licence and your intended use is not permitted by statutory regulation or exceeds the permitted use, you will need to obtain permission directly from the copyright holder. To view a copy of this licence, visit http://creativecommons.org/licenses/by/4.0/. The Creative Commons Public Domain Dedication waiver (http://creativeco mmons.org/publicdomain/zero/1.0/) applies to the data made available in this article, unless otherwise stated in a credit line to the data.Coudercetal. BMC Cancer (2022) 22:78 Page 2 of 7 Trial registration: The protocol was registered to the French drug and device regulation agency under the number 2019-A02319-48, before beginning the study (11/12/2019 ...
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