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NCT05710809Recruiting

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

Source: ClinicalTrials.gov · Last updated 6 Apr 2025 · Not updated for over 12 months - ask the site whether it is still open

Brief summary (registry, in English)

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

Status (registry)
Recruiting
Study type
Interventional
Enrollment
150 (estimated)
First submitted
16 Jan 2023
Start date
20 Feb 2023
Primary completion date
1 May 2027
Lead sponsor
Copenhagen University Hospital, Rigshospitalet
NCT number
NCT05710809

What you commit to

  • Study type: Interventional
  • Planned participants: 150
  • From 20 Feb 2023 to the primary completion date, 1 May 2027
  • 2 sites in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • Chemotherapy treatment within two years and sequelae of neuropathy, or symptoms of dizziness or vertigo, or balance disturbance

Other illness

  • Dementia, psychotic disorders, or other cognitive diseases or conditions that hinder participation in a clinical exercise-based trial

Other

  • Severe physical disability that hinders physical exercise
  • Inability to sign informed content
  • Patients who have had a consultation in the geriatric outpatient clinic within the past six months

Who the study is looking for

  • 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

Age in the registry: 65 years to - · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (2)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
Copenhagen University Hospital, Rigshospitalet
Coordinator of this site? Confirm its status
CopenhagenDenmarkNot yet recruiting
Copenhagen University Hospital - Herlev and Gentofte Hospital
Coordinator of this site? Confirm its status
HerlevDenmarkRecruiting

This page is information, not medical advice. Discuss any trial with your doctor.