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

Cancer Clinical Trial

— SaVe  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05710809
• Other study ID #: H-22064206
• Status: Recruiting
• Phase: N/A
• Start date: February 20, 2023
• Est. completion date: September 2026

Study information

• Verified date: April 2024
• Source: Rigshospitalet, Denmark
• Contact: Katrine S Piper, PhD-Student
• Phone: +4551156140
• Email: katrine.storm.piper[@]regionh.dk
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 150
• Est. completion date: September 2026
• Est. primary completion date: July 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 65 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Cancer
• Chemotherapy
• Chemotherapy-induced Peripheral Neuropathy
• Colorectal Cancer
• Colorectal Neoplasms
• Comprehensive Geriatric Assessment
• Dizziness
• Elderly
• Exercise
• Frail
• Geriatric
• Geriatric Oncology
• Older Adults
• Oncologic Complications
• Peripheral Nervous System Diseases
• Postural Stability
• Rehabilitation
• Resistance Training
• Sarcopenia
• Vertigo
• Vestibular Rehabilitation

Intervention

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

Locations

Country	Name	City	State
Denmark	Copenhagen University Hospital - Rigshospitalet	Copenhagen
Denmark	Copenhagen University Hospital - Herlev and Gentofte Hospital	Herlev

Sponsors (7)

Lead Sponsor

Collaborator

Rigshospitalet, Denmark

Copenhagen University Hospital - Amager and Hvidovre Hospital, Copenhagen University Hospital - Bispebjerg and Frederiksberg Hospital, Copenhagen University Hospital - Herlev and Gentofte Hospital, Department of Medicine, Copenhagen University Hospital - Herlev and Gentofte Hospital, Department of Oncology, Copenhagen University Hospital - Rigshospitalet, Department of Occupational Therapy and Physiotherapy, Odense University Hospital, Department of Geriatric Medicine

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Walking speed	Changes in walking speed using 10 meter walk test measuring gaitspeed in meters per second	Baseline, three and six months
Other	Postural control	Changes in postural control (standing balance) using HUR SmartBalance platform	Baseline, three and six months
Other	Vestibular function	Changes in peripheral vestibular function using Video Head Impulse Test (vHIT)	Baseline, three and six months
Other	Orthostatic blood pressure	Changes in orthostatic blood pressure measured from lying to standing and every minute for five minutes	Baseline, three and six months
Other	Body composition	Changes in body composition using bioimpedance (BIA)	Baseline, three and six months
Other	Muscle quality	Changes in muscle quality using ultrasound	Baseline and three months
Other	Frailty	Presence of frailty using Geriatric-8 (G8) scored on a 0-17 point scale. Higher score means better outcome	Baseline
Other	Frailty	Presence of frailty using Clinical Frailty Scale (CFS) scored on a 1-9 point scale. Higher score means worse outcome	Baseline
Other	Activity level	Description of activity level using activity tracker	Baseline and three months
Other	Cessation of chemotherapy	Description of cessation of chemotherapy	After 6, 12, and 24 weeks (from baseline)
Other	Prescribed rehabilitation plan	Recording of exercise through a prescribed rehabilitation plan	Follow-up at 1, 2, 3, and 5 years
Other	Overall survival	Recording of overall survival	Follow-up at 1, 2, 3, and 5 years
Other	Hospitalisations	Recording of hospitalisations	Follow-up at 1, 2, 3, and 5 years
Other	Progression of cancer	Recording of progression of cancer	Follow-up at 1, 2, 3, and 5 years
Other	Recurrence of cancer	Recording of recurrence of cancer	Follow-up at 1, 2, 3, and 5 years
Other	Biomarkers of sarcopenia and inflammation	Biomarkers of sarcopenia and inflammation collected through blood samples. To determine concentration of inflammatory cytokines; High-sensitivity C-reactive Protein (hsCRP), tumour necrosis factor alpha (TNF- a), interleukin 6 (IL6), interleukin 13 (IL-13), and of muscle atrophy and muscle wasting (growth differentiation factor 11 (GDF11), and growth differentiation factor 15 (GDF-15). Blood samples are analysed by standard ELISA-analyses for plasma samples.	Baseline, three and six months
Other	Vision	Measurement of vision using a Snellen chart	Baseline
Primary	Dynamic Gait Index (DGI)	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	Three months
Primary	30 second Sit-to-Stand Test (30STS)	Between-group difference in lower limb muscle strength and endurance	Three months
Secondary	Falls	Self-reported falls	Baseline, two, four, six, eight, ten, twelve, fourteen, sixteen, eighteen, twenty, twenty-two, and twenty-four weeks
Secondary	Hospital contacts due to falls	Hospital contacts due to falls	Baseline, three and six months
Secondary	Balance disabilities/dizziness	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	Baseline, three and six months
Secondary	Fear of falling	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	Baseline, three and six months
Secondary	Health related quality of life	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	Baseline, three and six months
Secondary	Peripheral nerve function	Changes in peripheral nerve function using biothesiometer mesured in 0-50 volts. Higher volts means worse outcome	Baseline, three and six months
Secondary	Autonomic function	Changes in autonomic function using Vagus device	Baseline, three and six months
Secondary	Chemotherapy induced peripheral neuropathy	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	Baseline, three and six months
Secondary	Muscle strength	Changes in muscle strength using HUR Leg Press Rehab performance recorder measuring weight in kilograms	Baseline, three and six months
Secondary	Body composition	Changes in body composition using DXA	Baseline, three and six months
Secondary	Muscle strength	Changes in muscle strength using handgrip test measuring weight in kilograms	Baseline, three and six months