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The SaVe project – Sarcopenia and Vertigo in aging patients with colorectal cancer: A study protocol for three randomized controlled trials
Older patients with cancer range from fit to frail with various comorbidities and resilience to chemotherapy. Besides nausea and fatigue, a significant number of patients experience dizziness and impaired walking balance after chemotherapy, which can have great impact on their functional ability and...
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| Published in: | Journal of geriatric oncology 2024-05, Vol.15 (4), p.101770-101770, Article 101770 |
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| container_end_page | 101770 |
| container_issue | 4 |
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| container_title | Journal of geriatric oncology |
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| creator | Piper, Katrine Storm Suetta, Charlotte Schou, Jakob Vasehus Ryg, Jesper Andersen, Hanne Elkjær Langevad, Line Vind Evering, Delaney Mikkelsen, Marta Kramer Lund, Cecilia Christensen, Jan |
| description | Older patients with cancer range from fit to frail with various comorbidities and resilience to chemotherapy. Besides nausea and fatigue, a significant number of patients experience dizziness and impaired walking balance after chemotherapy, which can have great impact on their functional ability and health related quality of life. Symptoms are easily overlooked and therefore often underreported and managed, which is why symptoms could end up as long-lasting side effects. The aim of this study is to investigate the development of dizziness, decline in walking balance, and sarcopenia and the effect of a comprehensive geriatric assessment and 12 weeks of group-based exercise on these symptoms. The exercise intervention includes vestibular and balance exercises, and progressive resistance training, to counteract the symptoms in older patients with colorectal cancer treated with chemotherapy.
This is a randomized controlled trial including patients ≥65 years initiating (neo)adjuvant or first-line palliative chemotherapy for colorectal cancer. Patients will undergo a comprehensive assessment program including measures of vestibular function, balance, muscle strength, mass, and endurance, peripheral and autonomic nerve function, and subjective measures of dizziness, concern of falling, and health related quality of life. Tests will be performed at baseline, 12, and 24 weeks. Patients will be placed in three different randomized controlled trials depending on chemotherapy regimen and randomized 1:1 to comprehensive geriatric assessment and exercise three times/week or control. Participants in both groups will continue with usual care, including standardized oncological treatment. In total, 150 patients are needed to assess the two primary outcomes of (1) maintenance of walking balance assessed with Dynamic Gait Index and (2) lower limb strength and endurance assessed with 30 Second Sit-to-Stand Test at 12 weeks. The primary outcomes will be analyzed using a mixed linear regression model investigating the between-group differences.
Trial enrollment began in April 2023 and is the first trial to evaluate reasons for dizziness, decline in walking balance, and sarcopenia in older patients receiving chemotherapy. The trial will provide new and valuable knowledge in how to assess, manage, and prevent dizziness, decline in walking balance, and sarcopenia in older patients with colorectal cancer.
The Regional Ethics Committee (j.nr. H-22064206). Danish Data Protection Agen |
| doi_str_mv | 10.1016/j.jgo.2024.101770 |
| format | article |
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This is a randomized controlled trial including patients ≥65 years initiating (neo)adjuvant or first-line palliative chemotherapy for colorectal cancer. Patients will undergo a comprehensive assessment program including measures of vestibular function, balance, muscle strength, mass, and endurance, peripheral and autonomic nerve function, and subjective measures of dizziness, concern of falling, and health related quality of life. Tests will be performed at baseline, 12, and 24 weeks. Patients will be placed in three different randomized controlled trials depending on chemotherapy regimen and randomized 1:1 to comprehensive geriatric assessment and exercise three times/week or control. Participants in both groups will continue with usual care, including standardized oncological treatment. In total, 150 patients are needed to assess the two primary outcomes of (1) maintenance of walking balance assessed with Dynamic Gait Index and (2) lower limb strength and endurance assessed with 30 Second Sit-to-Stand Test at 12 weeks. The primary outcomes will be analyzed using a mixed linear regression model investigating the between-group differences.
Trial enrollment began in April 2023 and is the first trial to evaluate reasons for dizziness, decline in walking balance, and sarcopenia in older patients receiving chemotherapy. The trial will provide new and valuable knowledge in how to assess, manage, and prevent dizziness, decline in walking balance, and sarcopenia in older patients with colorectal cancer.
The Regional Ethics Committee (j.nr. H-22064206). Danish Data Protection Agency (P-2023-86) and ClinicalTrials.gov (NCT05710809).</description><identifier>ISSN: 1879-4068</identifier><identifier>EISSN: 1879-4076</identifier><identifier>DOI: 10.1016/j.jgo.2024.101770</identifier><identifier>PMID: 38631243</identifier><language>eng</language><publisher>Netherlands: Elsevier Ltd</publisher><subject>Aged ; Aged, 80 and over ; Chemotherapy ; Colorectal cancer ; Colorectal Neoplasms - complications ; Dizziness ; Elderly ; Exercise Therapy - methods ; Female ; Geriatric Assessment ; Geriatric oncology ; Humans ; Impaired walking ; Male ; Older adults ; Postural Balance ; Quality of Life ; Randomized Controlled Trials as Topic ; Resistance Training - methods ; Sarcopenia ; Sarcopenia - therapy ; Vertigo ; Walking balance</subject><ispartof>Journal of geriatric oncology, 2024-05, Vol.15 (4), p.101770-101770, Article 101770</ispartof><rights>2024 Elsevier Ltd</rights><rights>Copyright © 2024 Elsevier Ltd. All rights reserved.</rights><lds50>peer_reviewed</lds50><woscitedreferencessubscribed>false</woscitedreferencessubscribed><cites>FETCH-LOGICAL-c305t-c60c10b53a1564ab04b539dd36be1e2a94cf677765df72aa8b656b312642f53c3</cites></display><links><openurl>$$Topenurl_article</openurl><openurlfulltext>$$Topenurlfull_article</openurlfulltext><thumbnail>$$Tsyndetics_thumb_exl</thumbnail><link.rule.ids>315,786,790,27957,27958</link.rule.ids><backlink>$$Uhttps://www.ncbi.nlm.nih.gov/pubmed/38631243$$D View this record in MEDLINE/PubMed$$Hfree_for_read</backlink></links><search><creatorcontrib>Piper, Katrine Storm</creatorcontrib><creatorcontrib>Suetta, Charlotte</creatorcontrib><creatorcontrib>Schou, Jakob Vasehus</creatorcontrib><creatorcontrib>Ryg, Jesper</creatorcontrib><creatorcontrib>Andersen, Hanne Elkjær</creatorcontrib><creatorcontrib>Langevad, Line Vind</creatorcontrib><creatorcontrib>Evering, Delaney</creatorcontrib><creatorcontrib>Mikkelsen, Marta Kramer</creatorcontrib><creatorcontrib>Lund, Cecilia</creatorcontrib><creatorcontrib>Christensen, Jan</creatorcontrib><title>The SaVe project – Sarcopenia and Vertigo in aging patients with colorectal cancer: A study protocol for three randomized controlled trials</title><title>Journal of geriatric oncology</title><addtitle>J Geriatr Oncol</addtitle><description>Older patients with cancer range from fit to frail with various comorbidities and resilience to chemotherapy. Besides nausea and fatigue, a significant number of patients experience dizziness and impaired walking balance after chemotherapy, which can have great impact on their functional ability and health related quality of life. Symptoms are easily overlooked and therefore often underreported and managed, which is why symptoms could end up as long-lasting side effects. The aim of this study is to investigate the development of dizziness, decline in walking balance, and sarcopenia and the effect of a comprehensive geriatric assessment and 12 weeks of group-based exercise on these symptoms. The exercise intervention includes vestibular and balance exercises, and progressive resistance training, to counteract the symptoms in older patients with colorectal cancer treated with chemotherapy.
This is a randomized controlled trial including patients ≥65 years initiating (neo)adjuvant or first-line palliative chemotherapy for colorectal cancer. Patients will undergo a comprehensive assessment program including measures of vestibular function, balance, muscle strength, mass, and endurance, peripheral and autonomic nerve function, and subjective measures of dizziness, concern of falling, and health related quality of life. Tests will be performed at baseline, 12, and 24 weeks. Patients will be placed in three different randomized controlled trials depending on chemotherapy regimen and randomized 1:1 to comprehensive geriatric assessment and exercise three times/week or control. Participants in both groups will continue with usual care, including standardized oncological treatment. In total, 150 patients are needed to assess the two primary outcomes of (1) maintenance of walking balance assessed with Dynamic Gait Index and (2) lower limb strength and endurance assessed with 30 Second Sit-to-Stand Test at 12 weeks. The primary outcomes will be analyzed using a mixed linear regression model investigating the between-group differences.
Trial enrollment began in April 2023 and is the first trial to evaluate reasons for dizziness, decline in walking balance, and sarcopenia in older patients receiving chemotherapy. The trial will provide new and valuable knowledge in how to assess, manage, and prevent dizziness, decline in walking balance, and sarcopenia in older patients with colorectal cancer.
The Regional Ethics Committee (j.nr. H-22064206). Danish Data Protection Agency (P-2023-86) and ClinicalTrials.gov (NCT05710809).</description><subject>Aged</subject><subject>Aged, 80 and over</subject><subject>Chemotherapy</subject><subject>Colorectal cancer</subject><subject>Colorectal Neoplasms - complications</subject><subject>Dizziness</subject><subject>Elderly</subject><subject>Exercise Therapy - methods</subject><subject>Female</subject><subject>Geriatric Assessment</subject><subject>Geriatric oncology</subject><subject>Humans</subject><subject>Impaired walking</subject><subject>Male</subject><subject>Older adults</subject><subject>Postural Balance</subject><subject>Quality of Life</subject><subject>Randomized Controlled Trials as Topic</subject><subject>Resistance Training - methods</subject><subject>Sarcopenia</subject><subject>Sarcopenia - therapy</subject><subject>Vertigo</subject><subject>Walking balance</subject><issn>1879-4068</issn><issn>1879-4076</issn><fulltext>true</fulltext><rsrctype>article</rsrctype><creationdate>2024</creationdate><recordtype>article</recordtype><recordid>eNp9UctOHDEQtCIiQMAHcIl85LIbP2bsHXJCKCGRkDhAuFoeu2fXo9nxxvaCyCk_wCl_mC9JjxY44kt321UldxUhp5zNOePqcz_vl3EumKimWWv2gRzyhW5mFdNq761XiwNyknPP8EjRNFrtkwO5UJKLSh6S57sV0Ft7D3STYg-u0H9__uJFcnEDY7DUjp7eQyphGWkYqV2GcUk3tgQYS6aPoayoi0NMSLUDdXZ0kM7pBc1l658m0RLxnXYx0bJKADShYlyH3-CROJYUhwHbkoId8jH52GGBk5d6RH5--3p3-X12fXP14_LieuYkq8vMKeY4a2tpea0q27IK-8Z7qVrgIGxTuU5prVXtOy2sXbSqVi1urCrR1dLJI3K208X__dpCLmYdsoNhsCPEbTaSVVyIRiiJUL6DuhRzTtCZTQprm54MZ2YKwvQGgzBTEGYXBHI-vchv2zX4N8ar7Qj4sgMALvkQIJns0FAHPkxGGh_DO_L_AR25muQ</recordid><startdate>202405</startdate><enddate>202405</enddate><creator>Piper, Katrine Storm</creator><creator>Suetta, Charlotte</creator><creator>Schou, Jakob Vasehus</creator><creator>Ryg, Jesper</creator><creator>Andersen, Hanne Elkjær</creator><creator>Langevad, Line Vind</creator><creator>Evering, Delaney</creator><creator>Mikkelsen, Marta Kramer</creator><creator>Lund, Cecilia</creator><creator>Christensen, Jan</creator><general>Elsevier Ltd</general><scope>CGR</scope><scope>CUY</scope><scope>CVF</scope><scope>ECM</scope><scope>EIF</scope><scope>NPM</scope><scope>AAYXX</scope><scope>CITATION</scope><scope>7X8</scope></search><sort><creationdate>202405</creationdate><title>The SaVe project – Sarcopenia and Vertigo in aging patients with colorectal cancer: A study protocol for three randomized controlled trials</title><author>Piper, Katrine Storm ; Suetta, Charlotte ; Schou, Jakob Vasehus ; Ryg, Jesper ; Andersen, Hanne Elkjær ; Langevad, Line Vind ; Evering, Delaney ; Mikkelsen, Marta Kramer ; Lund, Cecilia ; Christensen, Jan</author></sort><facets><frbrtype>5</frbrtype><frbrgroupid>cdi_FETCH-LOGICAL-c305t-c60c10b53a1564ab04b539dd36be1e2a94cf677765df72aa8b656b312642f53c3</frbrgroupid><rsrctype>articles</rsrctype><prefilter>articles</prefilter><language>eng</language><creationdate>2024</creationdate><topic>Aged</topic><topic>Aged, 80 and over</topic><topic>Chemotherapy</topic><topic>Colorectal cancer</topic><topic>Colorectal Neoplasms - complications</topic><topic>Dizziness</topic><topic>Elderly</topic><topic>Exercise Therapy - methods</topic><topic>Female</topic><topic>Geriatric Assessment</topic><topic>Geriatric oncology</topic><topic>Humans</topic><topic>Impaired walking</topic><topic>Male</topic><topic>Older adults</topic><topic>Postural Balance</topic><topic>Quality of Life</topic><topic>Randomized Controlled Trials as Topic</topic><topic>Resistance Training - methods</topic><topic>Sarcopenia</topic><topic>Sarcopenia - therapy</topic><topic>Vertigo</topic><topic>Walking balance</topic><toplevel>peer_reviewed</toplevel><toplevel>online_resources</toplevel><creatorcontrib>Piper, Katrine Storm</creatorcontrib><creatorcontrib>Suetta, Charlotte</creatorcontrib><creatorcontrib>Schou, Jakob Vasehus</creatorcontrib><creatorcontrib>Ryg, Jesper</creatorcontrib><creatorcontrib>Andersen, Hanne Elkjær</creatorcontrib><creatorcontrib>Langevad, Line Vind</creatorcontrib><creatorcontrib>Evering, Delaney</creatorcontrib><creatorcontrib>Mikkelsen, Marta Kramer</creatorcontrib><creatorcontrib>Lund, Cecilia</creatorcontrib><creatorcontrib>Christensen, Jan</creatorcontrib><collection>Medline</collection><collection>MEDLINE</collection><collection>MEDLINE (Ovid)</collection><collection>MEDLINE</collection><collection>MEDLINE</collection><collection>PubMed</collection><collection>CrossRef</collection><collection>MEDLINE - Academic</collection><jtitle>Journal of geriatric oncology</jtitle></facets><delivery><delcategory>Remote Search Resource</delcategory><fulltext>fulltext</fulltext></delivery><addata><au>Piper, Katrine Storm</au><au>Suetta, Charlotte</au><au>Schou, Jakob Vasehus</au><au>Ryg, Jesper</au><au>Andersen, Hanne Elkjær</au><au>Langevad, Line Vind</au><au>Evering, Delaney</au><au>Mikkelsen, Marta Kramer</au><au>Lund, Cecilia</au><au>Christensen, Jan</au><format>journal</format><genre>article</genre><ristype>JOUR</ristype><atitle>The SaVe project – Sarcopenia and Vertigo in aging patients with colorectal cancer: A study protocol for three randomized controlled trials</atitle><jtitle>Journal of geriatric oncology</jtitle><addtitle>J Geriatr Oncol</addtitle><date>2024-05</date><risdate>2024</risdate><volume>15</volume><issue>4</issue><spage>101770</spage><epage>101770</epage><pages>101770-101770</pages><artnum>101770</artnum><issn>1879-4068</issn><eissn>1879-4076</eissn><notes>ObjectType-Article-1</notes><notes>SourceType-Scholarly Journals-1</notes><notes>ObjectType-Feature-2</notes><notes>content type line 23</notes><notes>ObjectType-Undefined-3</notes><abstract>Older patients with cancer range from fit to frail with various comorbidities and resilience to chemotherapy. Besides nausea and fatigue, a significant number of patients experience dizziness and impaired walking balance after chemotherapy, which can have great impact on their functional ability and health related quality of life. Symptoms are easily overlooked and therefore often underreported and managed, which is why symptoms could end up as long-lasting side effects. The aim of this study is to investigate the development of dizziness, decline in walking balance, and sarcopenia and the effect of a comprehensive geriatric assessment and 12 weeks of group-based exercise on these symptoms. The exercise intervention includes vestibular and balance exercises, and progressive resistance training, to counteract the symptoms in older patients with colorectal cancer treated with chemotherapy.
This is a randomized controlled trial including patients ≥65 years initiating (neo)adjuvant or first-line palliative chemotherapy for colorectal cancer. Patients will undergo a comprehensive assessment program including measures of vestibular function, balance, muscle strength, mass, and endurance, peripheral and autonomic nerve function, and subjective measures of dizziness, concern of falling, and health related quality of life. Tests will be performed at baseline, 12, and 24 weeks. Patients will be placed in three different randomized controlled trials depending on chemotherapy regimen and randomized 1:1 to comprehensive geriatric assessment and exercise three times/week or control. Participants in both groups will continue with usual care, including standardized oncological treatment. In total, 150 patients are needed to assess the two primary outcomes of (1) maintenance of walking balance assessed with Dynamic Gait Index and (2) lower limb strength and endurance assessed with 30 Second Sit-to-Stand Test at 12 weeks. The primary outcomes will be analyzed using a mixed linear regression model investigating the between-group differences.
Trial enrollment began in April 2023 and is the first trial to evaluate reasons for dizziness, decline in walking balance, and sarcopenia in older patients receiving chemotherapy. The trial will provide new and valuable knowledge in how to assess, manage, and prevent dizziness, decline in walking balance, and sarcopenia in older patients with colorectal cancer.
The Regional Ethics Committee (j.nr. H-22064206). Danish Data Protection Agency (P-2023-86) and ClinicalTrials.gov (NCT05710809).</abstract><cop>Netherlands</cop><pub>Elsevier Ltd</pub><pmid>38631243</pmid><doi>10.1016/j.jgo.2024.101770</doi><tpages>1</tpages></addata></record> |
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| identifier | ISSN: 1879-4068 |
| ispartof | Journal of geriatric oncology, 2024-05, Vol.15 (4), p.101770-101770, Article 101770 |
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| language | eng |
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| source | ScienceDirect Journals |
| subjects | Aged Aged, 80 and over Chemotherapy Colorectal cancer Colorectal Neoplasms - complications Dizziness Elderly Exercise Therapy - methods Female Geriatric Assessment Geriatric oncology Humans Impaired walking Male Older adults Postural Balance Quality of Life Randomized Controlled Trials as Topic Resistance Training - methods Sarcopenia Sarcopenia - therapy Vertigo Walking balance |
| title | The SaVe project – Sarcopenia and Vertigo in aging patients with colorectal cancer: A study protocol for three randomized controlled trials |
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