Frailty in the Elderly Oncological and Oncohematological Patient.

Официальное название

Impatto Della Diagnosi di fragilità Sulla tossicità da Terapia in Pazienti Anziani Affetti da Tumore oncoLogIco e onCoEmatologico.

Обзор

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.

Вмешательства

• Другое Frailty evaluation
  Evaluation of the frailty impact on the toxicity grade 3-4 in patients undergoing chemotherapy treatment.

Первичные конечные точки

• Impact of frailty on grade 3-4 Chemotherapy Toxicity in Patients with Solid and Hematologic Malignancies. [Срок оценки: 12 months from screening]

Вторичные конечные точки (2)

• Identification of Sarcopenia and Frailty through Clinical Assessment [Срок оценки: 12 months from the screening]
• Correlation of Radiological, Functional, Clinical, and Laboratory Assessments in the Diagnosis of Sarcopenia and Frailty [Срок оценки: 12 months from screening]

Критерии участия

Критерии включения

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

Критерии исключения

• 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)

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Модель наблюдения

Только случаи

Центры проведения

Италия · 1 центр

• Trial Office-ASST Ovest Milanese — Legnano

Публикации

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• Cruz-Jentoft AJ, Baeyens JP, Bauer JM, Boirie Y, Cederholm T, Landi F, Martin FC, Michel JP, Rolland Y, Schneider SM, Topinkova E, Vandewoude M, Zamboni M; European Working Group on Sarcopenia in Older People. Sarcopenia: European consensus on definition and diagnosis: Report of the European Working Group on Sarcopenia in Older People. Age Ageing. 2010 Jul;39(4):412-23. doi: 10.1093/ageing/afq034. PMID 20392703
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• Williams A, Baruah D, Patel J, Szabo A, Chhabra S, Dhakal B, Hari P, Janz S, Stolley M, D'Souza A. Prevalence and significance of sarcopenia in multiple myeloma patients undergoing autologous hematopoietic cell transplantation. Bone Marrow Transplant. 2021 Jan;56(1):225-231. doi: 10.1038/s41409-020-01008-9. Epub 2020 Jul 30. PMID 32732941

Идентификаторы

NCT: NCT07624370 · 20-2024 · 5159

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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