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Clinical Trials in Denmark / NCT05710809
Recruiting Not applicable

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

NCT05710809 · tracked via the Priya Life Science Denmark tracker
Sponsor
Copenhagen University Hospital, Rigshospitalet
Phase
Not applicable
Started
2023-02-20
Last updated
2025-04-06

Condition(s) studied

Colorectal CancerOncologic ComplicationsComprehensive Geriatric AssessmentVestibular RehabilitationGeriatric OncologySarcopeniaVertigoCancerRehabilitationExerciseGeriatricElderlyFrailOlder AdultsChemotherapyChemotherapy-induced Peripheral NeuropathyResistance TrainingBalance TrainingPostural StabilityPragmatic TrialPersonal MedicineIndividualised

Investigational drug(s) / intervention(s)

Targeted specialized physical group-based exercise and Comprehensive Geriatric Assessement

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

Study 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

Sex
ALL
Min age
65 Years
Max age
—
Healthy volunteers
No
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

Primary outcome measure(s)

  • Dynamic Gait Index (DGI) — Three months
    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
  • 30 second Sit-to-Stand Test (30STS) — Three months
    Between-group difference in lower limb muscle strength and endurance

Trial sites (2)

FacilityCityRegionStatus
Copenhagen University Hospital - Rigshospitalet Copenhagen Denmark Not Yet Recruiting
Copenhagen University Hospital - Herlev and Gentofte Hospital Herlev Denmark Recruiting

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Other trials for the same condition

IMPROVE: Circulating Tumor DNA Analysis to Optimize Treatment for Patients With Colorectal Cancer Active, not recruiting
Cancer-associated Muscle Mass - Molecular Factors and Exercise Mechanisms Recruiting
Adjuvant Low Dose Aspirin in Colorectal Cancer Active, not recruiting
Colorectal Omics and OfCS Proteoglycans Recruiting
Nutritional Status and Patient Characteristics Upon Length of Stay, Clinical Outcome, and Survival in Older Hospitalized Patients Recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT05710809 on ClinicalTrials.gov ↗ ← All trials in Denmark