NCT05710809 The SaVe Project-Sarcopenia and Vertigo in Aging Patients With Colorectal Cancer
| NCT ID | NCT05710809 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Rigshospitalet, Denmark |
| Condition | Colorectal Cancer |
| Study Type | INTERVENTIONAL |
| Enrollment | 150 participants |
| Start Date | 2023-02-20 |
| Primary Completion | 2027-05-01 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 150 participants in total. It began in 2023-02-20 with a primary completion date of 2027-05-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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
Eligibility 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
Contact & Investigator
Frequently Asked Questions
Who can join the NCT05710809 clinical trial?
This trial is open to participants of all sexes, aged 65 Years or older, studying Colorectal Cancer. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT05710809 currently recruiting?
Yes, NCT05710809 is actively recruiting participants. Contact the research team at katrine.storm.piper@regionh.dk for enrollment information.
Where is the NCT05710809 trial being conducted?
This trial is being conducted at Copenhagen, Denmark, Herlev, Denmark.
Who is sponsoring the NCT05710809 clinical trial?
NCT05710809 is sponsored by Rigshospitalet, Denmark. The trial plans to enroll 150 participants.
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