Frailty/Sarcopenia, Hematologic Disease, Oncological Patients, Sarcopenia in Elderly
Conditions
Brief summary
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.
Interventions
OTHERFrailty evaluation
Evaluation of the frailty impact on the toxicity grade 3-4 in patients undergoing chemotherapy treatment.
Sponsors
Azienda Socio Sanitaria Territoriale Ovest Milanese, Ospedale di Legnano
Study design
Observational model
CASE_ONLY
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
70 Years to No maximum
Healthy volunteers
No
Inclusion criteria
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
Exclusion criteria
* 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)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Impact of frailty on grade 3-4 Chemotherapy Toxicity in Patients with Solid and Hematologic Malignancies. | 12 months from screening | Evaluation of the impact of frailty on the probability of grade 3 or 4 toxicity in patients with solid or hematologic malignancies undergoing chemotherapy treatment. Multidimensional geriatric assessment including: G8 (0-17): ≤14 = frail/vulnerable; \>14 = normal. IADL (0-8): higher scores indicate greater independence. CCI: 0-2 = low comorbidity; ≥3 = high comorbidity burden. SPPB (0-12): 10-12 = good, 7-9 = intermediate, ≤6 = poor physical performance. MUST: 0 = low, 1 = medium, ≥2 = high risk of malnutrition. Mini-Cog (0-5): ≥3 = normal cognition; \<3 = cognitive impairment. CARG: low, intermediate, or high risk of severe chemotherapy toxicity. MNA: ≥24 = normal; 17-23.5 = at risk of malnutrition; \<17 = malnourished. Laboratory tests: routine pre-chemotherapy assessments according to institutional standards. BIA: evaluation of body composition, muscle mass, and phase angle. CT/MRI: assessment of muscle area at L3/L4; sarcopenia defined as \<4.8 cm²/m² in women and \<6.6 cm²/m² in men |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Identification of Sarcopenia and Frailty through Clinical Assessment | 12 months from the screening | Agreement between CT/MRI and BIA for sarcopenia diagnosis and association with geriatric and laboratory parameters. G8 (0-17): ≤14 = frail/vulnerable; \>14 = normal. IADL (0-8): higher scores indicate greater independence. CCI: 0-2 = low comorbidity; ≥3 = high comorbidity burden. SPPB (0-12): 10-12 = good, 7-9 = intermediate, ≤6 = poor physical performance. MUST: 0 = low, 1 = medium, ≥2 = high risk of malnutrition. Mini-Cog (0-5): ≥3 = normal cognition; \<3 = cognitive impairment. CARG: low, intermediate, or high risk of severe chemotherapy toxicity. MNA: ≥24 = normal; 17-23.5 = at risk of malnutrition; \<17 = malnourished. Laboratory tests: routine pre-chemotherapy assessments according to institutional standards. BIA: evaluation of body composition, muscle mass, and phase angle. CT/MRI: assessment of muscle area at L3/L4; sarcopenia defined as \<4.8 cm²/m² in women and \<6.6 cm²/m² in men. |
| Correlation of Radiological, Functional, Clinical, and Laboratory Assessments in the Diagnosis of Sarcopenia and Frailty | 12 months from screening | Evaluation of the concordance between sarcopenia diagnosed through radiological imaging (CT/MRI) and that obtained through a functional assessment (bioelectrical impedance analysis), the correlation between instrumental assessments and clinical parameters (comprehensive geriatric assessment) for the diagnosis of sarcopenia/frailty, and the correlation between laboratory values and clinical-instrumental measures. |
Countries
Italy
Outcome results
None listed