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.
調査の概要
研究の種類
入学 (推定)
連絡先と場所
研究場所
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Italy
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Legnano、Italy、イタリア、20025
- Trial Office-ASST Ovest Milanese
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参加基準
適格基準
就学可能な年齢
- 高齢者
健康ボランティアの受け入れ
サンプリング方法
調査対象母集団
説明
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)
研究計画
研究はどのように設計されていますか？
デザインの詳細
コホートと介入
グループ/コホート |
介入・治療 |
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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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この研究は何を測定していますか？
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
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Impact of frailty on grade 3-4 Chemotherapy Toxicity in Patients with Solid and Hematologic Malignancies.
時間枠：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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二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
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Correlation of Radiological, Functional, Clinical, and Laboratory Assessments in the Diagnosis of Sarcopenia and Frailty
時間枠：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
時間枠：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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協力者と研究者
出版物と役立つリンク
一般刊行物
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- Shachar SS, Deal AM, Weinberg M, Nyrop KA, Williams GR, Nishijima TF, Benbow JM, Muss HB. Skeletal Muscle Measures as Predictors of Toxicity, Hospitalization, and Survival in Patients with Metastatic Breast Cancer Receiving Taxane-Based Chemotherapy. Clin Cancer Res. 2017 Feb 1;23(3):658-665. doi: 10.1158/1078-0432.CCR-16-0940. Epub 2016 Aug 3.
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研究記録日
主要日程の研究
研究開始 (実際)
一次修了 (実際)
研究の完了 (推定)
試験登録日
最初に提出
QC基準を満たした最初の提出物
最初の投稿 (実際)
学習記録の更新
投稿された最後の更新 (実際)
QC基準を満たした最後の更新が送信されました
最終確認日
詳しくは
本研究に関する用語
追加の関連 MeSH 用語
その他の研究ID番号
- 20-2024
- 5159 (その他の識別子：COMITATO ETICO TERRITORIALE LOMBARDIA 3)
個々の参加者データ (IPD) の計画
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