The SaVe Project-Sarcopenia and Vertigo in Aging Patients With Colorectal Cancer
SaVe
1 other identifier
interventional
150
1 country
2
Brief 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
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable colorectal-cancer
Started Feb 2023
Longer than P75 for not_applicable colorectal-cancer
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
January 16, 2023
CompletedFirst Posted
Study publicly available on registry
February 2, 2023
CompletedStudy Start
First participant enrolled
February 20, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 1, 2027
ExpectedStudy Completion
Last participant's last visit for all outcomes
September 1, 2027
April 6, 2025
April 1, 2025
4.2 years
January 16, 2023
April 2, 2025
Conditions
Outcome Measures
Primary Outcomes (2)
Dynamic Gait Index (DGI)
Between-group difference in change in walking balance assessed with Dynamic Gait Index (DGI) scored on a 0-24 point total scale. Higher score means better outcome
Three months
30 second Sit-to-Stand Test (30STS)
Between-group difference in lower limb muscle strength and endurance
Three months
Secondary Outcomes (11)
Falls
Baseline, two, four, six, eight, ten, twelve, fourteen, sixteen, eighteen, twenty, twenty-two, and twenty-four weeks
Hospital contacts due to falls
Baseline, three and six months
Balance disabilities/dizziness
Baseline, three and six months
Fear of falling
Baseline, three and six months
Health related quality of life
Baseline, three and six months
- +6 more secondary outcomes
Other Outcomes (17)
Walking speed
Baseline, three and six months
Postural control
Baseline, three and six months
Vestibular function
Baseline, three and six months
- +14 more other outcomes
Study Arms (2)
Intervention group
EXPERIMENTALPatients in the intervention groups will receive neoadjuvant, adjuvant or first line palliative chemotherapy (for metastatic disease). In addition, all patients will undergo three months' targeted specialized physical group-based exercise and Comprehensive Geriatric Assessment with corresponding interventions
Usual care group
NO INTERVENTIONPatients in the usual care groups will receive standard treatment with neoadjuvant, adjuvant or first line palliative chemotherapy (for metastatic disease). If the patients have other health complaints, these will, as current standard procedure, be treated by oncologist or by referral to general practitioner
Interventions
Vestibular rehabilitation, balance- and progressive resistance training for three months' three times/week and Comprehensive Geriatric Assessement including corresponding interventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Rigshospitalet, Denmarklead
- Copenhagen University Hospital - Rigshospitalet, Department of Occupational Therapy and Physiotherapycollaborator
- Copenhagen University Hospital at Herlevcollaborator
- University Hospital Bispebjerg and Frederiksbergcollaborator
- Odense University Hospital, Department of Geriatric Medicinecollaborator
- Amager Hospitalcollaborator
Study Sites (2)
Copenhagen University Hospital - Rigshospitalet
Copenhagen, 2400, Denmark
Copenhagen University Hospital - Herlev and Gentofte Hospital
Herlev, 2730, Denmark
Related Publications (1)
Piper KS, Suetta C, Schou JV, Ryg J, Andersen HE, Langevad LV, Evering D, Mikkelsen MK, Lund C, Christensen J. The SaVe project - Sarcopenia and Vertigo in aging patients with colorectal cancer: A study protocol for three randomized controlled trials. J Geriatr Oncol. 2024 May;15(4):101770. doi: 10.1016/j.jgo.2024.101770. Epub 2024 Apr 16.
PMID: 38631243DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- INVESTIGATOR, OUTCOMES ASSESSOR
- Masking Details
- Investigator = Statistician
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Senior researcher, Head of research
Study Record Dates
First Submitted
January 16, 2023
First Posted
February 2, 2023
Study Start
February 20, 2023
Primary Completion (Estimated)
May 1, 2027
Study Completion (Estimated)
September 1, 2027
Last Updated
April 6, 2025
Record last verified: 2025-04
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP, ICF, ANALYTIC CODE
On reasonable request