Frailty in the Elderly Oncological and Oncohematological Patient. (SALICE)
Impatto Della Diagnosi di fragilità Sulla tossicità da Terapia in Pazienti Anziani Affetti da Tumore oncoLogIco e onCoEmatologico.
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.
Studienübersicht
Status
Bedingungen
Intervention / Behandlung
Studientyp
Einschreibung (Geschätzt)
Kontakte und Standorte
Studienorte
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Italy
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Legnano, Italy, Italien, 20025
- Trial Office-ASST Ovest Milanese
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Teilnahmekriterien
Zulassungskriterien
Studienberechtigtes Alter
- Älterer Erwachsener
Akzeptiert gesunde Freiwillige
Probenahmeverfahren
Studienpopulation
Beschreibung
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)
Studienplan
Wie ist die Studie aufgebaut?
Designdetails
Kohorten und Interventionen
Gruppe / Kohorte |
Intervention / Behandlung |
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Frail patients with solid tumors and hematologic malignancies.
This cohort includes frail patients diagnosed with solid tumors or hematologic malignancies, to evaluate the impact of frailty on clinical outcome.
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Evaluation of the frailty impact on the toxicity grade 3-4 in patients undergoing chemotherapy treatment.
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Was misst die Studie?
Primäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
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Impact of frailty on grade 3-4 Chemotherapy Toxicity in Patients with Solid and Hematologic Malignancies.
Zeitfenster: 12 months from screening
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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 |
12 months from screening
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Sekundäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
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Correlation of Radiological, Functional, Clinical, and Laboratory Assessments in the Diagnosis of Sarcopenia and Frailty
Zeitfenster: 12 months from screening
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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.
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12 months from screening
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Identification of Sarcopenia and Frailty through Clinical Assessment
Zeitfenster: 12 months from the screening
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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. |
12 months from the screening
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Mitarbeiter und Ermittler
Publikationen und hilfreiche Links
Allgemeine Veröffentlichungen
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- Polverelli N, Tura P, Battipaglia G, Malagola M, Bernardi S, Gandolfi L, Zollner T, Zanaglio C, Farina M, Morello E, Turra A, Mohty M, Russo D. Multidimensional geriatric assessment for elderly hematological patients (>/=60 years) submitted to allogeneic stem cell transplantation. A French-Italian 10-year experience on 228 patients. Bone Marrow Transplant. 2020 Dec;55(12):2224-2233. doi: 10.1038/s41409-020-0934-1. Epub 2020 May 12.
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Studienaufzeichnungsdaten
Haupttermine studieren
Studienbeginn (Tatsächlich)
Primärer Abschluss (Tatsächlich)
Studienabschluss (Geschätzt)
Studienanmeldedaten
Zuerst eingereicht
Zuerst eingereicht, das die QC-Kriterien erfüllt hat
Zuerst gepostet (Tatsächlich)
Studienaufzeichnungsaktualisierungen
Letztes Update gepostet (Tatsächlich)
Letztes eingereichtes Update, das die QC-Kriterien erfüllt
Zuletzt verifiziert
Mehr Informationen
Begriffe im Zusammenhang mit dieser Studie
Zusätzliche relevante MeSH-Bedingungen
- Neurologische Manifestationen
- Erkrankungen des Nervensystems
- Neuromuskuläre Manifestationen
- Pathologische Prozesse
- Pathologische Zustände, Anatomisch
- Muskelatrophie
- Atrophie
- Pathologische Zustände, Anzeichen und Symptome
- Anzeichen und Symptome
- Hämische und lymphatische Krankheiten
- Gebrechlichkeit
- Sarkopenie
- Hämatologische Erkrankungen
Andere Studien-ID-Nummern
- 20-2024
- 5159 (Andere Kennung: COMITATO ETICO TERRITORIALE LOMBARDIA 3)
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