The SaVe project - Sarcopenia and Vertigo in aging patients with colorectal cancer: A study protocol for three randomized controlled trials.
Katrine Storm Piper, Charlotte Suetta, Jakob Vasehus Schou...
https://pubmed.ncbi.nlm.nih.gov/38631243Actively Recruiting
Phase Not Applicable
Age: 65Years +
All Genders
ID05710809
The SaVe Project-Sarcopenia and Vertigo in Aging Patients With Colorectal Cancer
Led by Rigshospitalet, Denmark · Updated on 2025-04-06
150
Participants Needed
2
Research Sites
17 weeks
Total Duration
On this page
Sponsors
R
Rigshospitalet, Denmark
Lead Sponsor
C
Copenhagen University Hospital - Rigshospitalet, Department of Occupational Therapy and Physiotherapy
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are investigating the causes of dizziness and reduced walking ability in adults aged 65 and older undergoing chemotherapy for colorectal cancer. The study aims to understand how muscle weakness, vertigo, instability, impaired balance, and chemotherapy-induced peripheral neuropathy affect these patients. It also explores whether a comprehensive geriatric assessment combined with specialized physical exercises can help counteract these issues. Participants are divided into two groups: one receiving standard chemotherapy plus a three-month program of group-based physical exercises three times a week along with a comprehensive geriatric assessment and related interventions, and the other receiving only standard chemotherapy and usual care. The exercise program includes vestibular rehabilitation, balance training, and progressive resistance exercises designed to improve muscle strength and balance. During the study, participants will be monitored regularly through tests measuring walking ability and muscle strength, as well as assessments of falls, dizziness, fear of falling, quality of life, nerve and autonomic functions, and chemotherapy side effects. These evaluations occur at baseline and at multiple points over six months. The study also tracks hospital visits related to falls and aims to assess how these interventions may help improve patients' overall health and reduce hospital admissions over time.
CONDITIONS
Brief Title
The SaVe Project-Sarcopenia and Vertigo in Aging Patients With Colorectal Cancer
Who Can Participate
Age: 65Years +
All Genders
Eligibility Criteria
You may qualify if you...
- Receiving neoadjuvant, adjuvant, or first line palliative chemotherapy for colorectal cancer
- 65 years of age or older at the time of signing the informed consent form
- Able to speak and read Danish and provide signed informed consent
- Have an Eastern Cooperative Oncology Group (ECOG) performance status score of 2 or less
You will not qualify if you...
- Chemotherapy treatment within the past two years with neuropathy, dizziness, vertigo, or balance disturbance
- Severe physical disability preventing physical exercise
- Dementia, psychotic disorders, or other cognitive conditions hindering participation
- Unable to sign informed consent
- Having had a consultation in the geriatric outpatient clinic within the past six months
AI-Screening
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2
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Your Study Journey
Screening
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Treatment
Duration - Three months
Participants in the intervention group receive targeted specialized physical group-based exercise three times per week for three months along with a Comprehensive Geriatric Assessment and corresponding interventions during chemotherapy. Participants in the usual care group receive standard chemotherapy treatment.
Weekly visits for up to 12 weeks
Follow-up
Duration - Up to six months after treatment
Participants are monitored for falls, balance disabilities, fear of falling, quality of life, peripheral nerve and autonomic function, chemotherapy induced peripheral neuropathy, muscle strength, and body composition up to six months after treatment.
Visits at baseline, three months, and six months with additional assessments for falls at multiple time points up to 24 weeks
Trial Site Locations
Total: 2 locations
1
Copenhagen University Hospital - Rigshospitalet
Copenhagen, Denmark, 2400
Not Yet Recruiting
2
Copenhagen University Hospital - Herlev and Gentofte Hospital
Herlev, Denmark, 2730
Actively Recruiting
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Research Team
K
Katrine S Piper, PhD-Student
J
Jan Christensen, PhD
How is the study designed?
Study Type
INTERVENTIONAL
Masking
DOUBLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
PREVENTION
Number of Arms
2
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