An interventional study of Targeted specialized physical group-based exercise and Comprehensive Geriatric Assessement in Colorectal Cancer, Oncologic Complications and Comprehensive Geriatric Assessment, sponsored by Rigshospitalet, Denmark. Recruiting at 2 sites in Denmark. Open to participants aged 65 Years and older. Per ClinicalTrials.gov, last updated 2025-04-06.
Sponsored by Rigshospitalet, Denmark · Not applicable, Interventional, and Prevention
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.
6,541 studies on the registry are indexed under Colorectal Neoplasms; 1,667 are open to participants now.
This study's planned enrollment of 150 is above the median of 76 across 4,800 interventional studies indexed under Colorectal Neoplasms.
Browse Colorectal Neoplasms studies →Rigshospitalet, Denmark is the lead sponsor of 1,007 studies on the registry; 175 are open to participants now.
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Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Neoadjuvant treatment is given before the main treatment (usually surgery), often to shrink a tumour. Adjuvant treatment is given after it, to lower the chance of the cancer coming back.
A line of therapy is one course of treatment, which may combine several drugs. First-line is the first course given; second-line follows when that stops working or is not tolerated.
“Two prior lines” means two courses that count separately under the study’s rules — not simply two drugs. Ask the study team if you are unsure how yours are counted.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
A scale of how much an illness limits everyday activity. For people being assessed to join a study, scores run from 0 (fully active) to 4; lower is more active.
Studies most often ask for 0–1 or 0–2. Your doctor gives the score; the WHO scale uses the same steps. The full scale also has 5, which records death.
Adjuvant and neoadjuvant
Neoadjuvant treatment is given before the main treatment (usually surgery), often to shrink a tumour. Adjuvant treatment is given after it, to lower the chance of the cancer coming back.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Line of therapy
A line of therapy is one course of treatment, which may combine several drugs. First-line is the first course given; second-line follows when that stops working or is not tolerated.
“Two prior lines” means two courses that count separately under the study’s rules — not simply two drugs. Ask the study team if you are unsure how yours are counted.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ECOG performance status
A scale of how much an illness limits everyday activity. For people being assessed to join a study, scores run from 0 (fully active) to 4; lower is more active.
Studies most often ask for 0–1 or 0–2. Your doctor gives the score; the WHO scale uses the same steps. The full scale also has 5, which records death.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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
Other: Targeted specialized physical group-based exercise and Comprehensive Geriatric Assessement
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
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
Time frame: Three months
30 second Sit-to-Stand Test (30STS)
Between-group difference in lower limb muscle strength and endurance
Time frame: Three months
Falls
Self-reported falls
Time frame: Baseline, two, four, six, eight, ten, twelve, fourteen, sixteen, eighteen, twenty, twenty-two, and twenty-four weeks
Hospital contacts due to falls
Hospital contacts due to falls
Time frame: Baseline, three and six months
Balance disabilities/dizziness
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
Time frame: Baseline, three and six months
Fear of falling
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
Time frame: Baseline, three and six months
Health related quality of life
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
Time frame: Baseline, three and six months
Peripheral nerve function
Changes in peripheral nerve function using biothesiometer mesured in 0-50 volts. Higher volts means worse outcome
Time frame: Baseline, three and six months
Autonomic function
Changes in autonomic function using Vagus device
Time frame: Baseline, three and six months
Chemotherapy induced peripheral neuropathy
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
Time frame: Baseline, three and six months
Muscle strength
Changes in muscle strength using HUR Leg Press Rehab performance recorder measuring weight in kilograms
Time frame: Baseline, three and six months
Body composition
Changes in body composition using DXA
Time frame: Baseline, three and six months
Muscle strength
Changes in muscle strength using handgrip test measuring weight in kilograms
Time frame: Baseline, three and six months
Walking speed
Changes in walking speed using 10 meter walk test measuring gaitspeed in meters per second
Time frame: Baseline, three and six months
Postural control
Changes in postural control (standing balance) using HUR SmartBalance platform
Time frame: Baseline, three and six months
Vestibular function
Changes in peripheral vestibular function using Video Head Impulse Test (vHIT)
Time frame: Baseline, three and six months
Orthostatic blood pressure
Changes in orthostatic blood pressure measured from lying to standing and every minute for five minutes
Time frame: Baseline, three and six months
Body composition
Changes in body composition using bioimpedance (BIA)
Time frame: Baseline, three and six months
Muscle quality
Changes in muscle quality using ultrasound
Time frame: Baseline and three months
Frailty
Presence of frailty using Geriatric-8 (G8) scored on a 0-17 point scale. Higher score means better outcome
Time frame: Baseline
Frailty
Presence of frailty using Clinical Frailty Scale (CFS) scored on a 1-9 point scale. Higher score means worse outcome
Time frame: Baseline
Activity level
Description of activity level using activity tracker
Time frame: Baseline and three months
Cessation of chemotherapy
Description of cessation of chemotherapy
Time frame: After 6, 12, and 24 weeks (from baseline)
Prescribed rehabilitation plan
Recording of exercise through a prescribed rehabilitation plan
Time frame: Follow-up at 1, 2, 3, and 5 years
Overall survival
Recording of overall survival
Time frame: Follow-up at 1, 2, 3, and 5 years
Hospitalisations
Recording of hospitalisations
Time frame: Follow-up at 1, 2, 3, and 5 years
Progression of cancer
Recording of progression of cancer
Time frame: Follow-up at 1, 2, 3, and 5 years
Recurrence of cancer
Recording of recurrence of cancer
Time frame: Follow-up at 1, 2, 3, and 5 years
Biomarkers of sarcopenia and inflammation
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.
Time frame: Baseline, three and six months
Vision
Measurement of vision using a Snellen chart
Time frame: Baseline
Plan to share: Yes — On reasonable request
Supporting information: Study protocol, Statistical analysis plan, Informed consent form, Analytic code
No publications or documents are linked to this record.
Started Feb 2023 (actual). Primary completion is estimated for May 2027, 50 months after the start.
Of 898 non-industry interventional studies with no phase under Colorectal Neoplasms, half reached primary completion within 32 months of starting (the median), counting those still running; a quarter within 15 and three quarters within 62. This study's planned 50 months is above that.
Counting every sponsor, half of 955 studies reached it within 32 months; a quarter within 14 and three quarters within 60.
How these figures are worked out, and which studies are left out of them.
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