Health Trials

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

ConditionsColorectal CancerOncologic ComplicationsComprehensive Geriatric AssessmentVestibular RehabilitationGeriatric OncologySarcopeniaVertigoCancerRehabilitationExerciseGeriatricElderlyFrailOlder AdultsChemotherapyChemotherapy-induced Peripheral NeuropathyResistance TrainingBalance TrainingPostural StabilityPragmatic TrialPersonal MedicineIndividualised
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age65+
SponsorRigshospitalet, Denmark

About this trial

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

Qualifiers

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

Disqualifiers

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

Trial design

Treatments tested in this trial

  • Targeted specialized physical group-based exercise and Comprehensive Geriatric Assessement

Treatment groups

150 Participants
are divided into 2 treatment groups

Sponsors and collaborators

Rigshospitalet, Denmark

Lead sponsor

Copenhagen University Hospital - Rigshospitalet, Department of Occupational Therapy and Physiotherapy

Collaborator

Copenhagen University Hospital at Herlev

Collaborator

University Hospital Bispebjerg and Frederiksberg

Collaborator

Odense University Hospital, Department of Geriatric Medicine

Collaborator

Amager Hospital

Collaborator

Source ClinicalTrials.gov