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

Not Applicable

Recruiting

• Conditions: Sarcopenia; Rehabilitation; Exercise; Pragmatic Trial; Vertigo; Frail; Chemotherapy; Chemotherapy-induced Peripheral Neuropathy; Resistance Training; Postural Stability
• Interventions: Other: Targeted specialized physical group-based exercise and Comprehensive Geriatric Assessement

• Registration Number: NCT05710809
• Lead Sponsor: Rigshospitalet, Denmark

Brief 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.

Study Timeline

• Study First Submitted: 2023-01-16
• Study First Submitted QC: 2023-01-25
• Study First Posted: 2023-02-02
• Study Start: 2023-02-20
• Status Verified: 2025-04
• Last Update Submitted: 2025-04-02
• Last Update Posted: 2025-04-06
• Primary Completion: 2027-05-01
• Study Completion: 2027-09

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 150

Inclusion Criteria

• Meet the criteria of the oncological departments of receiving neoadjuvant, adjuvant or first line palliative chemotherapy for colorectal cancer
• ≥65 years of age at the time of signing the informed consent form
• Able to speak and read Danish, and to provide a signed informed consent form
• Have an Eastern Cooperative Oncology Group (ECOG) performance status score of ≤2

Exclusion Criteria

• Chemotherapy treatment within two years and sequelae of neuropathy, or symptoms of dizziness or vertigo, or balance disturbance
• Severe physical disability that hinders physical exercise
• Dementia, psychotic disorders, or other cognitive diseases or conditions that hinder participation in a clinical exercise-based trial
• Inability to sign informed content
• Patients who have had a consultation in the geriatric outpatient clinic within the past six months

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Intervention group	Targeted specialized physical group-based exercise and Comprehensive Geriatric Assessement	Patients in the intervention groups will receive neoadjuvant, adjuvant or first line palliative chemotherapy (for metastatic disease). In addition, all patients will undergo three months' targeted specialized physical group-based exercise and Comprehensive Geriatric Assessment with corresponding interventions

Primary Outcome Measures

Name	Time	Method
30 second Sit-to-Stand Test (30STS)	Three months	Between-group difference in lower limb muscle strength and endurance
Dynamic Gait Index (DGI)	Three months	Between-group difference in change in walking balance assessed with Dynamic Gait Index (DGI) scored on a 0-24 point total scale. Higher score means better outcome

Secondary Outcome Measures

Name	Time	Method
Hospital contacts due to falls	Baseline, three and six months	Hospital contacts due to falls
Body composition	Baseline, three and six months	Changes in body composition using DXA
Fear of falling	Baseline, three and six months	Changes in fear of falling using the patient reported outcome measure Short Falls Efficacy Scale International (Short FES-I) scored on a 0-28 point total scale. Higher score means worse outcome
Health related quality of life	Baseline, three and six months	Changes in health related quality of life using the patient reported outcome measure EORTC QLQ-C30. The total score is converted to a 0-100 scale. Higher score means better outcome
Peripheral nerve function	Baseline, three and six months	Changes in peripheral nerve function using biothesiometer mesured in 0-50 volts. Higher volts means worse outcome
Autonomic function	Baseline, three and six months	Changes in autonomic function using Vagus device
Falls	Baseline, two, four, six, eight, ten, twelve, fourteen, sixteen, eighteen, twenty, twenty-two, and twenty-four weeks	Self-reported falls
Balance disabilities/dizziness	Baseline, three and six months	Changes in self-perceived balance disabilities/dizziness using the patient reported outcome measure Dizziness Handicap Inventory (DHI) scored on a 0-100 point total scale. Higher score means worse outcome
Chemotherapy induced peripheral neuropathy	Baseline, three and six months	Severity of chemotherapy induced peripheral neuropathy using the patient reported outcome measure EORTC QLQ-CIPN-20. The total score is converted to a 0-100 scale. Higher score means worse outcome
Muscle strength	Baseline, three and six months	Changes in muscle strength using handgrip test measuring weight in kilograms

Trial Locations

Locations (2)

Copenhagen University Hospital - Rigshospitalet; 🇩🇰 Copenhagen, Denmark

Copenhagen University Hospital - Herlev and Gentofte Hospital; 🇩🇰 Herlev, Denmark