Clinical trial · Interventional
The SaVe Project-Sarcopenia and Vertigo in Aging Patients With Colorectal Cancer
NCT05710809CI-TRIAL-00088244SaVerecruitingN/AClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions
Conditions (22)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Balance Training | — | UNRESOLVED | — |
| Cancer | Malignant Neoplasm | ALIAS | 0.90 |
| Chemotherapy | — | UNRESOLVED | — |
| Chemotherapy-induced Peripheral Neuropathy | — | UNRESOLVED | — |
| Colorectal Cancer | Malignant Colorectal Neoplasm | CURATED_BROADER | 0.80 |
| Comprehensive Geriatric Assessment | — | UNRESOLVED | — |
| Elderly | — | UNRESOLVED | — |
| Exercise | — | UNRESOLVED | — |
| Frail | — | UNRESOLVED | — |
| Geriatric | — | UNRESOLVED | — |
| Geriatric Oncology | — | UNRESOLVED |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Targeted specialized physical group-based exercise and Comprehensive Geriatric Assessement | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Intervention group
- description
- 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
- interventionNames
- Other: Targeted specialized physical group-based exercise and Comprehensive Geriatric Assessement
- type
- NO_INTERVENTION
- label
- Usual care group
- description
- 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
Primary outcomes (2)
- measure
- Dynamic Gait Index (DGI)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 65 Years
Show eligibility criteria text
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
References
Publications (1)
- DERIVEDPiper KS, Suetta C, Schou JV, Ryg J, Andersen HE, Langevad LV, Evering D, Mikkelsen MK, Lund C, Christensen J. The SaVe project - Sarcopenia and Vertigo in aging patients with colorectal cancer: A study protocol for three randomized controlled trials. J Geriatr Oncol. 2024 May;15(4):101770. doi: 10.1016/j.jgo.2024.101770. Epub 2024 Apr 16. PMID 38631243