NCT05710809

The SaVe Project-Sarcopenia and Vertigo in Aging Patients With Colorectal Cancer

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 150 (estimated)
• Sponsor: Rigshospitalet, Denmark · Academic / Other
• Sex: All
• Age: 65 Years
• Healthy volunteers: Not accepted

Summary

The goal of this clinical trial is to learn about the cause of dizziness and decline in walking ability in in older adults ≥65 years during chemotherapy treatment for colorectal cancer. Another goal is to investigate if a comprehensive geriatric assessment and three months' specialized physical group-based exercise three times/week can counteract muscle weakness, vertigo, instability, impaired walking balance, and neuropathy

Detailed description

Frequent adverse effects of chemotherapy in older adults are nausea and fatigue, but our research group have discovered a problem with many also suffering from sarcopenia, vertigo, dizziness, and peripheral neuropathy (CIPN) leading to balance and walking impairments causing increased risk of falls. Moreover, these symptoms are often underreported with inadequate awareness among health professionals leading to deficient focus on the need for targeted rehabilitation. A comprehensive geriatric assessment (CGA) can increase the number of frail, older patients completing chemotherapy and CGA-based interventions can decrease chemotherapy toxicity and improve health-related quality of life (HRQoL). Physical exercise has been shown to reduce muscle weakness, vertigo, dizziness, and impaired balance among older adults requiring limited resources. Therefore, this project aims to investigate the effectiveness of CGA and physical exercise to counteract muscle weakness, vertigo, instability, and impaired walking balance, during chemotherapy and to investigate the interaction between vertigo, postural stability and walking performance, and neuropathy and the prevalence of sarcopenia. The activities of specialized physical exercise planned in this intervention will, as hypothesized, result in a change in muscle strength, walking balance, self-perceived balance disabilities/dizziness, and fear of falling along with changes in peripheral nerve function and autonomic function and severity of CIPN which are the outcomes of this study. Accordingly, expectations are that this intervention will affect the HRQoL among older cancer patients with vertigo and walking impairments and reduce the number of falls and hospital admissions leading to a socioeconomic benefit.

Conditions

• Colorectal Cancer
• Oncologic Complications
• Comprehensive Geriatric Assessment
• Vestibular Rehabilitation
• Geriatric Oncology
• Sarcopenia
• Vertigo
• Cancer
• Rehabilitation
• Exercise
• Geriatric
• Elderly
• Frail
• Older Adults
• Chemotherapy
• Chemotherapy-induced Peripheral Neuropathy
• Resistance Training
• Balance Training
• Postural Stability
• Pragmatic Trial
• Personal Medicine
• Individualised

Interventions

Type	Name	Description
OTHER	Targeted specialized physical group-based exercise and Comprehensive Geriatric Assessement	Vestibular rehabilitation, balance- and progressive resistance training for three months' three times/week and Comprehensive Geriatric Assessement including corresponding interventions

Timeline

• Start date: 2023-02-20
• Primary completion: 2027-05-01
• Completion: 2027-09-01
• First posted: 2023-02-02
• Last updated: 2025-04-06

Locations

2 sites across 1 country: Denmark