Impatto Della Diagnosi di fragilità Sulla tossicità da Terapia in Pazienti Anziani Affetti da Tumore oncoLogIco e onCoEmatologico.
试验速览
- 阶段
- 不适用
- 状态
- Enrolling By Invitation
- 发起方
- 入组人数
- 160
- 试验地点
- 1
研究概览
简要总结
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Prospective
入排标准
- 年龄范围
- 70 Years 至 —（Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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)