TY - JOUR

T1 - The SaVe project – Sarcopenia and Vertigo in aging patients with colorectal cancer

T2 - A study protocol for three randomized controlled trials

AU - Piper, Katrine Storm

AU - Suetta, Charlotte

AU - Schou, Jakob Vasehus

AU - Ryg, Jesper

AU - Andersen, Hanne Elkjær

AU - Langevad, Line Vind

AU - Evering, Delaney

AU - Mikkelsen, Marta Kramer

AU - Lund, Cecilia

AU - Christensen, Jan

N1 - Publisher Copyright: © 2024 Elsevier Ltd

PY - 2024

Y1 - 2024

N2 - Introduction: 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. Materials and Methods: 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. Discussion: 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. Trial Registration: The Regional Ethics Committee (j.nr. H-22064206). Danish Data Protection Agency (P-2023-86) and ClinicalTrials.gov (NCT05710809).

AB - Introduction: 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. Materials and Methods: 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. Discussion: 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. Trial Registration: The Regional Ethics Committee (j.nr. H-22064206). Danish Data Protection Agency (P-2023-86) and ClinicalTrials.gov (NCT05710809).

KW - Chemotherapy

KW - Colorectal cancer

KW - Dizziness

KW - Elderly

KW - Geriatric oncology

KW - Impaired walking

KW - Older adults

KW - Sarcopenia

KW - vertigo

KW - Walking balance

U2 - 10.1016/j.jgo.2024.101770

DO - 10.1016/j.jgo.2024.101770

M3 - Journal article

C2 - 38631243

AN - SCOPUS:85190318886

VL - 15

JO - Journal of Geriatric Oncology

JF - Journal of Geriatric Oncology

SN - 1879-4068

IS - 4

M1 - 101770

ER -