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Search / Trial NCT05710809

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

Launched by RIGSHOSPITALET, DENMARK · Jan 25, 2023

Trial Information

Current as of June 26, 2025

Recruiting

Keywords

ClinConnect Summary

The SaVe Project is a clinical trial aimed at understanding why older adults (65 years and older) with colorectal cancer often experience dizziness and difficulty walking during their chemotherapy treatment. The researchers want to see if a thorough assessment of the participants' health and a specialized exercise program, which includes group-based physical activities three times a week for three months, can help improve muscle strength, balance, and overall stability while reducing symptoms like vertigo (dizziness) and neuropathy (nerve pain).

To be eligible for this trial, participants need to be receiving specific types of chemotherapy for colorectal cancer and be able to read and speak Danish. They must also have a good level of functioning according to a standard performance scale. However, individuals with recent chemotherapy side effects, severe disabilities, or cognitive impairments that could limit their ability to participate are not eligible. Those who join can expect supportive group exercise sessions designed to enhance their physical well-being and possibly improve their quality of life during treatment.

Gender

ALL

Eligibility criteria

  • 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

About Rigshospitalet, Denmark

Rigshospitalet, located in Copenhagen, Denmark, is one of the leading hospitals in Scandinavia and a prominent center for clinical research and innovation. As a key academic institution affiliated with the University of Copenhagen, Rigshospitalet is dedicated to advancing healthcare through rigorous clinical trials and groundbreaking research across various medical disciplines. The hospital’s commitment to excellence is reflected in its multidisciplinary approach, collaboration with international research networks, and focus on improving patient outcomes through evidence-based practices. With state-of-the-art facilities and a team of highly qualified professionals, Rigshospitalet plays a crucial role in translating scientific discoveries into effective treatments and therapies.

Locations

Copenhagen, , Denmark

Herlev, , Denmark

Patients applied

0 patients applied

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported

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