Clinical trial NCT05710809: The SaVe Project-Sarcopenia and Vertigo in Aging Patients With Colorectal Cancer
Official title: The SaVe Project-Sarcopenia and Vertigo in Aging Patients With Colorectal Cancer
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
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
Lead sponsor: Rigshospitalet, Denmark
Sponsor class: OTHER
Collaborators: name: Copenhagen University Hospital - Rigshospitalet, Department of Occupational Therapy and Physiotherapy
name: Copenhagen University Hospital - Herlev and Gentofte Hospital, Department of Medicine
name: Copenhagen University Hospital - Herlev and Gentofte Hospital, Department of Oncology
name: Copenhagen University Hospital - Bispebjerg and Frederiksberg Hospital
name: Odense University Hospital, Department of Geriatric Medicine
name: Copenhagen University Hospital - Amager and Hvidovre Hospital
First posted: 2023-02-02
Enrollment: 150
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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

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.

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

Primary outcomes:
measure: Dynamic Gait Index (DGI)
timeFrame: Three months
measure: 30 second Sit-to-Stand Test (30STS)
timeFrame: Three months
Secondary outcomes:
measure: Falls
timeFrame: Baseline, two, four, six, eight, ten, twelve, fourteen, sixteen, eighteen, twenty, twenty-two, and twenty-four weeks
measure: Hospital contacts due to falls
timeFrame: Baseline, three and six months
measure: Balance disabilities/dizziness
timeFrame: Baseline, three and six months
measure: Fear of falling
timeFrame: Baseline, three and six months
measure: Health related quality of life
timeFrame: Baseline, three and six months
measure: Peripheral nerve function
timeFrame: Baseline, three and six months
measure: Autonomic function
timeFrame: Baseline, three and six months
measure: Chemotherapy induced peripheral neuropathy
timeFrame: Baseline, three and six months
measure: Muscle strength
timeFrame: Baseline, three and six months
measure: Body composition
timeFrame: Baseline, three and six months
measure: Muscle strength
timeFrame: Baseline, three and six months
Other outcomes:
measure: Walking speed
timeFrame: Baseline, three and six months
measure: Postural control
timeFrame: Baseline, three and six months
measure: Vestibular function
timeFrame: Baseline, three and six months
measure: Orthostatic blood pressure
timeFrame: Baseline, three and six months
measure: Body composition
timeFrame: Baseline, three and six months
measure: Muscle quality
timeFrame: Baseline and three months
measure: Frailty
timeFrame: Baseline
measure: Frailty
timeFrame: Baseline
measure: Activity level
timeFrame: Baseline and three months
measure: Cessation of chemotherapy
timeFrame: After 6, 12, and 24 weeks (from baseline)
measure: Prescribed rehabilitation plan
timeFrame: Follow-up at 1, 2, 3, and 5 years
measure: Overall survival
timeFrame: Follow-up at 1, 2, 3, and 5 years
measure: Hospitalisations
timeFrame: Follow-up at 1, 2, 3, and 5 years
measure: Progression of cancer
timeFrame: Follow-up at 1, 2, 3, and 5 years
measure: Recurrence of cancer
timeFrame: Follow-up at 1, 2, 3, and 5 years
measure: Biomarkers of sarcopenia and inflammation
timeFrame: Baseline, three and six months
measure: Vision
timeFrame: Baseline
Locations:
city: Copenhagen
country: Denmark
facility: Copenhagen University Hospital - Rigshospitalet
city: Herlev
country: Denmark
facility: Copenhagen University Hospital - Herlev and Gentofte Hospital
Study officials:
References: