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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT05710809
Recruitment Status : Not yet recruiting
First Posted : February 2, 2023
Last Update Posted : February 2, 2023
Sponsor:
Collaborators:
Copenhagen University Hospital - Rigshospitalet, Department of Occupational Therapy and Physiotherapy
Copenhagen University Hospital - Herlev and Gentofte Hospital, Department of Medicine
Copenhagen University Hospital - Herlev and Gentofte Hospital, Department of Oncology
Copenhagen University Hospital - Bispebjerg and Frederiksberg Hospital
Odense University Hospital, Department of Geriatric Medicine
Copenhagen University Hospital - Amager and Hvidovre Hospital
Information provided by (Responsible Party):
Jan Christensen, Rigshospitalet, Denmark

Study Description
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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

Condition or disease Intervention/treatment Phase
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 Other: Targeted specialized physical group-based exercise and Comprehensive Geriatric Assessement Phase 3

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.
Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 150 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Investigator, Outcomes Assessor)
Masking Description: Investigator = Statistician
Primary Purpose: Prevention
Official Title: The SaVe Project-Sarcopenia and Vertigo in Aging Patients With Colorectal Cancer
Estimated Study Start Date : February 2023
Estimated Primary Completion Date : July 2025
Estimated Study Completion Date : January 2026

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: Intervention group
Patients in the intervention groups will receive 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
Vestibular rehabilitation, balance- and progressive resistance training for three months' three times/week and Comprehensive Geriatric Assessement including corresponding interventions
No Intervention: Usual care group
Patients in the usual care groups will receive standard treatment with 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


Outcome Measures
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Primary Outcome Measures :
  1. Dynamic Gait Index (DGI) [ Time Frame: Three months ]
    Between-group difference in change in walking balance assessed with Dynamic Gait Index (DGI)


Secondary Outcome Measures :
  1. Falls [ Time Frame: Baseline, three and six months ]
    Self-reported falls

  2. Hospital contacts due to falls [ Time Frame: Baseline, three and six months ]
    Hospital contacts due to falls

  3. Balance disabilities/dizziness [ Time Frame: Baseline, three and six months ]
    Changes in self-perceived balance disabilities/dizziness using the patient reported outcome measure Dizziness Handicap Inventory (DHI)

  4. Fear of falling [ Time Frame: Baseline, three and six months ]
    Changes in fear of falling using the patient reported outcome measure Falls Efficacy Scale International (FES-I)

  5. Health related quality of life [ Time Frame: Baseline, three and six months ]
    Changes in health related quality of life using the patient reported outcome measure EORTC QLQ-C30

  6. Peripheral nerve function [ Time Frame: Baseline, three and six months ]
    Changes in peripheral nerve function using biothesiometer

  7. Autonomic function [ Time Frame: Baseline, three and six months ]
    Changes in autonomic function using Vagus device

  8. Chemotherapy induced peripheral neuropathy [ Time Frame: Baseline, three and six months ]
    Severity of chemotherapy induced peripheral neuropathy using the patient reported outcome measure EORTC QLQ-CIPN-20

  9. Muscle strength [ Time Frame: Baseline, three and six months ]
    Changes in muscle strength using HUR Leg Press Rehab performance recorder, handgrip test and 30 second chair stand test

  10. Body composition [ Time Frame: Baseline, three and six months ]
    Changes in body composition using DXA


Other Outcome Measures:
  1. Walking speed [ Time Frame: Baseline, three and six months ]
    Changes in walking speed using 10 meter walk test

  2. Postural control [ Time Frame: Baseline, three and six months ]
    Changes in postural control (standing balance) using HUR SmartBalance platform

  3. Vestibular function [ Time Frame: Baseline, three and six months ]
    Changes in peripheral vestibular function using Video Head Impulse Test (vHIT)

  4. Gait analysis [ Time Frame: Baseline, three and six months ]
    Changes in gait quality regarding balance using a motion tracker

  5. Orthostatic blood pressure [ Time Frame: Baseline, three and six months ]
    Changes in orthostatic blood pressure measured from lying to standing and every minute for five minutes

  6. Body composition [ Time Frame: Baseline, three and six months ]
    Changes in body composition using bioimpedance

  7. Muscle quality [ Time Frame: Baseline and three months ]
    Changes in muscle quality using muscle biopsy

  8. Muscle quality [ Time Frame: Baseline and three months ]
    Changes in muscle quality using ultrasound

  9. Frailty [ Time Frame: Baseline ]
    Presence of frailty using Geriatric-8 (G8)

  10. Frailty [ Time Frame: Baseline ]
    Presence of frailty using Clinical Frailty Scale (CFS)

  11. Activity level [ Time Frame: Baseline and three months ]
    Description of activity level using activity tracker

  12. Cessation of chemotherapy [ Time Frame: After 6, 12, and 24 weeks (from baseline) ]
    Description of cessation of chemotherapy

  13. Exercise habits [ Time Frame: Follow-up at 1, 2, 3, and 5 years ]
    Recording of exercise habits

  14. Overall survival [ Time Frame: Follow-up at 1, 2, 3, and 5 years ]
    Recording of overall survival

  15. Hospitalisations [ Time Frame: Follow-up at 1, 2, 3, and 5 years ]
    Recording of hospitalisations

  16. Progression of cancer [ Time Frame: Follow-up at 1, 2, 3, and 5 years ]
    Recording of progression of cancer

  17. Recurrence of cancer [ Time Frame: Follow-up at 1, 2, 3, and 5 years ]
    Recording of recurrence of cancer


Eligibility Criteria
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Ages Eligible for Study:   65 Years and older   (Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Meet the criteria of the oncological departments of receiving adjuvant chemotherapy 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:

  • Other malignant disease except from basal cell carcinoma and carcinoma in situ cervices uteri within five years
  • Have recieved chemotherapy within five years
  • 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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05710809


Contacts
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Contact: Katrine S Piper, Msc katrine.storm.piper@regionh.dk
Contact: Jan Christensen, PhD jan.christensen.02@regionh.dk

Sponsors and Collaborators
Rigshospitalet, Denmark
Copenhagen University Hospital - Rigshospitalet, Department of Occupational Therapy and Physiotherapy
Copenhagen University Hospital - Herlev and Gentofte Hospital, Department of Medicine
Copenhagen University Hospital - Herlev and Gentofte Hospital, Department of Oncology
Copenhagen University Hospital - Bispebjerg and Frederiksberg Hospital
Odense University Hospital, Department of Geriatric Medicine
Copenhagen University Hospital - Amager and Hvidovre Hospital
More Information
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Responsible Party: Jan Christensen, Senior researcher, Head of research, Rigshospitalet, Denmark
ClinicalTrials.gov Identifier: NCT05710809    
Other Study ID Numbers: H-22064206
First Posted: February 2, 2023    Key Record Dates
Last Update Posted: February 2, 2023
Last Verified: January 2023
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: On reasonable request
Supporting Materials: Study Protocol
Statistical Analysis Plan (SAP)
Informed Consent Form (ICF)
Analytic Code

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Colorectal Neoplasms
Vertigo
Peripheral Nervous System Diseases
Sarcopenia
Dizziness
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Digestive System Diseases
Gastrointestinal Diseases
Colonic Diseases
Intestinal Diseases
 Rectal Diseases
Neuromuscular Diseases
Nervous System Diseases
Muscular Atrophy
Neuromuscular Manifestations
Neurologic Manifestations
Atrophy
Pathological Conditions, Anatomical
Vestibular Diseases
Labyrinth Diseases
Ear Diseases
Otorhinolaryngologic Diseases
Sensation Disorders