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

ConditionsColorectal 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

Trial statusRecruiting

Trial phaseNot applicable

Trial typeInterventional

Biological sexAll

Age65+

SponsorRigshospitalet, Denmark

About this trial

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

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

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

Trial design

Design model

Parallel

Treatments tested in this trial

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

Treatment groups

150 Participants

are divided into 2 treatment groups

Group A: Intervention groupExperimental treatment 1 intervention

Group B: Usual care groupNo intervention 0 interventions

Trial outcomes

Primary outcomes

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

Time frame

Three months

30 second Sit-to-Stand Test (30STS)

Between-group difference in lower limb muscle strength and endurance

Time frame

Three months

Secondary outcomes

Falls

Self-reported falls

Time frame

Baseline, two, four, six, eight, ten, twelve, fourteen, sixteen, eighteen, twenty, twenty-two, and twenty-four weeks

Hospital contacts due to falls

Time frame