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.
연구 개요
연구 유형
등록 (추정된)
연락처 및 위치
연구 장소
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Italy
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Legnano, Italy, 이탈리아, 20025
- Trial Office-ASST Ovest Milanese
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참여기준
자격 기준
공부할 수 있는 나이
- 고령자
건강한 자원 봉사자를 받아들입니다
샘플링 방법
연구 인구
설명
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)
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
코호트 및 개입
그룹/코호트 |
개입 / 치료 |
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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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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Impact of frailty on grade 3-4 Chemotherapy Toxicity in Patients with Solid and Hematologic Malignancies.
기간: 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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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Correlation of Radiological, Functional, Clinical, and Laboratory Assessments in the Diagnosis of Sarcopenia and Frailty
기간: 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
기간: 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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공동 작업자 및 조사자
간행물 및 유용한 링크
일반 간행물
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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.
- Fried LP, Ferrucci L, Darer J, Williamson JD, Anderson G. Untangling the concepts of disability, frailty, and comorbidity: implications for improved targeting and care. J Gerontol A Biol Sci Med Sci. 2004 Mar;59(3):255-63. doi: 10.1093/gerona/59.3.m255.
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연구 시작 (실제)
기본 완료 (실제)
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최초 제출
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연구 기록 업데이트
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마지막으로 확인됨
추가 정보
이 연구와 관련된 용어
추가 관련 MeSH 약관
기타 연구 ID 번호
- 20-2024
- 5159 (기타 식별자: COMITATO ETICO TERRITORIALE LOMBARDIA 3)
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