The SaVe Project-Sarcopenia and Vertigo in Aging Patients With Colorectal Cancer

Rigshospitalet

Status: Enrolling

Conditions: Balance Training; Geriatric; Vertigo; Chemotherapy-induced Peripheral Neuropathy; Resistance Training; Older Adults; Comprehensive Geriatric Assessment; Elderly; Cancer; Individualised; Exercise; Geriatric Oncology; Pragmatic Trial; Vestibular Rehabilitation; Rehabilitation; Postural Stability; Chemotherapy; Frail; Oncologic Complications; Sarcopenia; Personal Medicine; Colorectal Cancer

Treatments: Other: Targeted specialized physical group-based exercise and Comprehensive Geriatric Assessement

Study type: Interventional

Funder types: Other

Identifiers

NCT05710809

H-22064206

Details and patient eligibility

About

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

Full 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.

Enrollment: 150 estimated patients

Sex: All

Ages: 65+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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150 participants in 2 patient groups

Intervention group

Experimental group

Description:

Patients 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

Treatment:

Other: Targeted specialized physical group-based exercise and Comprehensive Geriatric Assessement

Usual care group

No Intervention group

Description:

Patients 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