The SaVe Project-Sarcopenia and Vertigo in Aging Patients With Colorectal Cancer
Recruiting · NCT05710809 · Interventional (participants receive a specific treatment) · Lead sponsor: Rigshospitalet, Denmark
View the official record on ClinicalTrials.gov →Interventions studied
Targeted specialized physical group-based exercise and Comprehensive Geriatric Assessement
What this trial is about
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
Who can take part
Age range
65 Years and older
Sex
All (male and female)
Healthy volunteers
No - a diagnosis or condition is required
Phase
Not applicable (e.g. observational or device study)
Study type
Interventional (participants receive a specific treatment)
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
Where it is running
2 locations listed.
- Copenhagen University Hospital - Rigshospitalet - Copenhagen, Denmark
- Copenhagen University Hospital - Herlev and Gentofte Hospital - Herlev, Denmark