Investigating dizziness and muscle weakness in older colorectal cancer patients during chemotherapy
The SaVe Project-Sarcopenia and Vertigo in Aging Patients With Colorectal Cancer
This study is testing whether a special exercise program and health check-ups can help older colorectal cancer patients feel less dizzy and improve their balance during chemotherapy.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 150 (estimated) |
| Ages | 65 Years and up |
| Sex | All |
| Sponsor | Rigshospitalet, Denmark Academic / other |
| Drugs / interventions | chemotherapy |
| Locations | 2 sites (Copenhagen and 1 other locations) |
| Trial ID | NCT05710809 on ClinicalTrials.gov |
What this trial studies
This clinical trial aims to understand the causes of dizziness and walking difficulties in older adults aged 65 and above undergoing chemotherapy for colorectal cancer. It will assess the effectiveness of a comprehensive geriatric assessment and a specialized physical exercise program conducted three times a week over three months. The study focuses on addressing issues such as sarcopenia, vertigo, and impaired balance, which are often overlooked in this population. By combining geriatric assessments with targeted rehabilitation, the trial seeks to improve the quality of life and treatment outcomes for older cancer patients.
Who should consider this trial
Good fit: Ideal candidates are older adults aged 65 and above who are receiving chemotherapy for colorectal cancer and can participate in physical exercise.
Not a fit: Patients with severe physical disabilities, recent chemotherapy treatment, or cognitive impairments may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could enhance the physical well-being and quality of life for older adults undergoing chemotherapy by reducing dizziness and improving balance.
How similar studies have performed: Previous studies have shown that comprehensive geriatric assessments and targeted physical exercise can significantly improve outcomes in older cancer patients, indicating a promising approach.
Eligibility criteria
Show full inclusion / exclusion criteria
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 this trial is running
Copenhagen and 1 other locations
- Copenhagen University Hospital - Rigshospitalet — Copenhagen, Denmark (Not_yet_recruiting)
- Copenhagen University Hospital - Herlev and Gentofte Hospital — Herlev, Denmark (Recruiting)
Study contacts
- Study coordinator: Katrine S Piper, PhD-Student
- Email: katrine.storm.piper@regionh.dk
- Phone: +4551156140
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.