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
Main Authors: 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
Format: Article
Language:English
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
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Summary: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
ISSN:1879-4068
1879-4076
DOI:10.1016/j.jgo.2024.101770