Nervous System Diseases

Symptoms and General Pathology

All Conditions

Ear, Nose, and Throat Diseases

Neoplasms

Digestive System Diseases

Sarcopenia

Peripheral Nervous System Diseases

Vertigo

Dizziness

Colorectal Neoplasms

Intestinal Neoplasms

Gastrointestinal Neoplasms

Digestive System Neoplasms

Gastrointestinal Diseases

Colonic Diseases

Intestinal Diseases

Rectal Diseases

Muscular Atrophy

Atrophy

Neuromuscular Manifestations

Neurologic Manifestations

Pathological Conditions, Anatomical

Neuromuscular Diseases

Vestibular Diseases

Labyrinth Diseases

Labyrinthitis

Ear Diseases

Otorhinolaryngologic Diseases

Sensation Disorders

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

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

Vestibular rehabilitation, balance- and progressive resistance training for three months' three times/week and Comprehensive Geriatric Assessement including corresponding interventions

Targeted specialized physical group-based exercise and Comprehensive Geriatric Assessement

Katrine S Piper, PhD-Student

Jan Christensen, PhD

Cecilia M Lund, PhD

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

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.

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

Changes in walking speed using 10 meter walk test measuring gaitspeed in meters per second

Changes in postural control (standing balance) using HUR SmartBalance platform

Changes in peripheral vestibular function using Video Head Impulse Test (vHIT)

Changes in orthostatic blood pressure measured from lying to standing and every minute for five minutes

Changes in body composition using bioimpedance (BIA)

Changes in muscle quality using ultrasound

Presence of frailty using Geriatric-8 (G8) scored on a 0-17 point scale. Higher score means better outcome

Presence of frailty using Clinical Frailty Scale (CFS) scored on a 1-9 point scale. Higher score means worse outcome

Description of activity level using activity tracker

Recording of exercise through a prescribed rehabilitation plan

Biomarkers of sarcopenia and inflammation collected through blood samples. To determine concentration of inflammatory cytokines; High-sensitivity C-reactive Protein (hsCRP), tumour necrosis factor alpha (TNF- α), interleukin 6 (IL6), interleukin 13 (IL-13), and of muscle atrophy and muscle wasting (growth differentiation factor 11 (GDF11), and growth differentiation factor 15 (GDF-15). Blood samples are analysed by standard ELISA-analyses for plasma samples.

Measurement of vision using a Snellen chart

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

Between-group difference in lower limb muscle strength and endurance

Changes in self-perceived balance disabilities/dizziness using the patient reported outcome measure Dizziness Handicap Inventory (DHI) scored on a 0-100 point total scale. Higher score means worse outcome

Changes in fear of falling using the patient reported outcome measure Short Falls Efficacy Scale International (Short FES-I) scored on a 0-28 point total scale. Higher score means worse outcome

Changes in health related quality of life using the patient reported outcome measure EORTC QLQ-C30. The total score is converted to a 0-100 scale. Higher score means better outcome

Changes in peripheral nerve function using biothesiometer mesured in 0-50 volts. Higher volts means worse outcome

Changes in autonomic function using Vagus device

Severity of chemotherapy induced peripheral neuropathy using the patient reported outcome measure EORTC QLQ-CIPN-20. The total score is converted to a 0-100 scale. Higher score means worse outcome

Changes in muscle strength using HUR Leg Press Rehab performance recorder measuring weight in kilograms

Changes in muscle strength using handgrip test measuring weight in kilograms

Spots Global Cancer Trial Database for postural stability