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NCT05710809
The SaVe Project-Sarcopenia and Vertigo in Aging Patients With Colorectal Cancer
Conditions: Colorectal Cancer, Oncologic Complications, Comprehensive Geriatric Assessment, Vestibular Rehabilitation, Geriatric Oncology, Sarcopenia, Vertigo, Cancer, Rehabilitation, Exercise, Geriatric, Elderly, Frail, Older Adults, Chemotherapy, Chemotherapy-induced Peripheral Neuropathy, Resistance Training, Balance Training, Postural Stability, Pragmatic Trial, Personal Medicine, Individualised
Sex: All
Ages: 65 Years – N/A
Phase: PHASE3
Enrollment: 150
Sponsor: Rigshospitalet, Denmark
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 adjuvant chemotherapy or first line palliative chemotherapy for colorectal cancer≥65 years of age at the time of signing the informed consent formAble to speak and read Danish, and to provide a signed informed consent formHave an Eastern Cooperative Oncology Group (ECOG) performance status score of ≤2Exclusion Criteria:Other malignant disease except from basal cell carcinoma and carcinoma in situ cervices uteri within five yearsHave recieved chemotherapy within five yearsSevere physical disability that hinders physical exerciseDementia, psychotic disorders, or other cognitive diseases or conditions that hinder participation in a clinical exercise-based trialInability to sign informed contentPatients who have had a consultation in the geriatric outpatient clinic within the past six months
Source: ClinicalTrials.gov (NCT05710809). StuddyBuddy aggregates publicly available trial information.