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

Status: Recruiting
Location: See all (2) locations...
Intervention Type: Other
Study Type: Interventional
Study Phase: Not Applicable
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

Eligibility
Participation Requirements
Sex: All
Minimum Age: 65
Healthy Volunteers: f
View:

• 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

Locations
Other Locations
Denmark
Copenhagen University Hospital - Rigshospitalet
NOT_YET_RECRUITING
Copenhagen
Copenhagen University Hospital - Herlev and Gentofte Hospital
RECRUITING
Herlev
Contact Information
Primary
Katrine S Piper, PhD-Student
katrine.storm.piper@regionh.dk
+4551156140
Backup
Jan Christensen, PhD
jan.christensen.02@regionh.dk
Time Frame
Start Date: 2023-02-20
Estimated Completion Date: 2027-09
Participants
Target number of participants: 150
Treatments
Experimental: Intervention group
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
No_intervention: Usual care group
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
Sponsors
Collaborators: Odense University Hospital, Department of Geriatric Medicine, Copenhagen University Hospital at Herlev, Copenhagen University Hospital - Rigshospitalet, Department of Occupational Therapy and Physiotherapy, Copenhagen University Hospital - Amager and Hvidovre Hospital, Copenhagen University Hospital - Bispebjerg and Frederiksberg Hospital
Leads: Rigshospitalet, Denmark

This content was sourced from clinicaltrials.gov