Frailty in the Elderly Oncological and Oncohematological Patient.
Enrolling by invitation
Conditions studied: Sarcopenia in Elderly, Frailty/Sarcopenia, Oncological Patients, Hematologic Disease
In brief
The Italian population is progressively aging, and cancer incidence increases with age. Older patients are at higher risk of frailty, a condition associated with adverse outcomes such as disability, falls, hospitalization, and mortality. Key indicators of frailty include reduced balance, impaired physical activity, cognitive decline, and particularly sarcopenia, defined as the progressive loss of skeletal muscle mass and strength. After age 60, muscle mass decreases by 1.4-2.5% annually, while muscle strength declines by 15% between ages 60-70 and by up to 30% per decade thereafter. Sarcopenia increases the risk of falls, fractures, hospitalization, and non-cancer-related death. In cancer patients, its prevalence ranges from 11% to 74% and is associated with poorer survival outcomes in both early and advanced disease stages.In clinical oncology practice, several tools are available to assess frailty, identify vulnerable patients, and personalize care, treatment, and supportive interventions.
Key facts
- Study ID
- NCT07624370
- Run by
- Azienda Socio Sanitaria Territoriale Ovest Milanese, Ospedale di Legnano
- People needed
- 160
- Starts
- 2025-03-21
- Expected to finish
- 2028-12-13
- Last updated by the study team
- 2026-06-08
Who can join
Age: 70 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- Inclusion criteria for patients with solid tumors:
- Cytological or histological diagnosis of lung cancer or gastrointestinal tract tumors (esophageal, gastric, intestinal, colorectal, pancreatic, and biliary tract cancers), mesothelioma.
- Age ≥ 70 years
- Patients deemed eligible, at the investigator's discretion, for first-line treatment including at least one chemotherapeutic agent
- Previous treatments (e.g., adjuvant therapy) are allowed if completed at least one year prior to randomization
- ECOG performance status 0, 1, or 2
- Written informed consent obtained
- Inclusion criteria for patients with hematologic malignancies:
- Cytological or histological diagnosis of multiple myeloma or lymphoma
- Age ≥ 70 years
- Patients deemed eligible, at the investigator's discretion, for first-line systemic treatment
- ECOG performance status 0, 1, 2, or 3
- Written informed consent obtained
You may not qualify if…
- Brain metastases (in solid tumors)
- Symptomatic bone lesions (in solid tumors)
- Cardiac disease classified as NYHA class III or IV
- Current or prior prostate or breast cancer receiving hormonal therapy (GnRH agonists or antagonists, androgen inhibitors, estrogen inhibitors)
- Acute leukemia
- Patients with pacemakers or implantable cardioverter-defibrillators (ICD)
Where it is running
- Trial Office-ASST Ovest Milanese — Legnano, Italy, Italy
Full record on ClinicalTrials.gov
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