RecruitingNot ApplicableNCT05710809

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


Sponsor

Rigshospitalet, Denmark

Enrollment

150 participants

Start Date

Feb 20, 2023

Study Type

INTERVENTIONAL

Conditions

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

Min Age: 65 Years

Inclusion Criteria4

  • 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 Criteria5

  • 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

Interventions

OTHERTargeted 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


Locations(2)

Copenhagen University Hospital - Rigshospitalet

Copenhagen, Denmark

Copenhagen University Hospital - Herlev and Gentofte Hospital

Herlev, Denmark

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NCT05710809


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