Trial Title:
The SaVe Project-Sarcopenia and Vertigo in Aging Patients With Colorectal Cancer
NCT ID:
NCT05710809
Condition:
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
Conditions: Official terms:
Colorectal Neoplasms
Vertigo
Sarcopenia
Peripheral Nervous System Diseases
Dizziness
Study type:
Interventional
Study phase:
N/A
Overall status:
Recruiting
Study design:
Allocation:
Randomized
Intervention model:
Parallel Assignment
Primary purpose:
Prevention
Masking:
Double (Investigator, Outcomes Assessor)
Masking description:
Investigator = Statistician
Intervention:
Intervention type:
Other
Intervention name:
Targeted specialized physical group-based exercise and Comprehensive Geriatric Assessement
Description:
Vestibular rehabilitation, balance- and progressive resistance training for three months'
three times/week and Comprehensive Geriatric Assessement including corresponding
interventions
Arm group label:
Intervention group
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
Detailed description:
Frequent adverse effects of chemotherapy in older adults are nausea and fatigue, but our
research group have discovered a problem with many also suffering from sarcopenia,
vertigo, dizziness, and peripheral neuropathy (CIPN) leading to balance and walking
impairments causing increased risk of falls. Moreover, these symptoms are often
underreported with inadequate awareness among health professionals leading to deficient
focus on the need for targeted rehabilitation. A comprehensive geriatric assessment (CGA)
can increase the number of frail, older patients completing chemotherapy and CGA-based
interventions can decrease chemotherapy toxicity and improve health-related quality of
life (HRQoL). Physical exercise has been shown to reduce muscle weakness, vertigo,
dizziness, and impaired balance among older adults requiring limited resources.
Therefore, this project aims to investigate the effectiveness of CGA and physical
exercise to counteract muscle weakness, vertigo, instability, and impaired walking
balance, during chemotherapy and to investigate the interaction between vertigo, postural
stability and walking performance, and neuropathy and the prevalence of sarcopenia. The
activities of specialized physical exercise planned in this intervention will, as
hypothesized, result in a change in muscle strength, walking balance, self-perceived
balance disabilities/dizziness, and fear of falling along with changes in peripheral
nerve function and autonomic function and severity of CIPN which are the outcomes of this
study. Accordingly, expectations are that this intervention will affect the HRQoL among
older cancer patients with vertigo and walking impairments and reduce the number of falls
and hospital admissions leading to a socioeconomic benefit.
Criteria for eligibility:
Criteria:
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
Gender:
All
Minimum age:
65 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
Copenhagen University Hospital - Rigshospitalet
Address:
City:
Copenhagen
Zip:
2400
Country:
Denmark
Status:
Not yet recruiting
Contact:
Last name:
Jan Christensen, PhD
Phone:
38633092
Email:
jan.christensen.02@regionh.dk
Investigator:
Last name:
Katrine S Piper, PhD-Student
Email:
Principal Investigator
Facility:
Name:
Copenhagen University Hospital - Herlev and Gentofte Hospital
Address:
City:
Herlev
Zip:
2730
Country:
Denmark
Status:
Recruiting
Contact:
Last name:
Cecilia M Lund, PhD
Phone:
+4538686112
Email:
Cecilia.Margareta.Lund.01@regionh.dk
Investigator:
Last name:
Katrine S Piper, PhD-Student
Email:
Principal Investigator
Start date:
February 20, 2023
Completion date:
September 2026
Lead sponsor:
Agency:
Rigshospitalet, Denmark
Agency class:
Other
Collaborator:
Agency:
Copenhagen University Hospital - Rigshospitalet, Department of Occupational Therapy and Physiotherapy
Agency class:
Other
Collaborator:
Agency:
Copenhagen University Hospital - Herlev and Gentofte Hospital, Department of Medicine
Agency class:
Other
Collaborator:
Agency:
Copenhagen University Hospital - Herlev and Gentofte Hospital, Department of Oncology
Agency class:
Other
Collaborator:
Agency:
Copenhagen University Hospital - Bispebjerg and Frederiksberg Hospital
Agency class:
Other
Collaborator:
Agency:
Odense University Hospital, Department of Geriatric Medicine
Agency class:
Other
Collaborator:
Agency:
Copenhagen University Hospital - Amager and Hvidovre Hospital
Agency class:
Other
Source:
Rigshospitalet, Denmark
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05710809
