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临床试验/NCT07405307
NCT07405307已完成不适用

Evaluation of the Proportion of Patients With Gastrointestinal Cancer Who Have Symptoms of Sarcopenia

Institute of Oncology Ljubljana1 个研究点 分布在 1 个国家目标入组 44 人开始时间: 2023年9月1日最近更新:
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
44
试验地点
1
主要终点
Proportion of gastrointestinal cancer patients with positive SARC-F screening

研究概览

简要总结

Sarcopenia is a syndrome characterized by progressive loss of skeletal muscle mass and strength and is associated with worse outcomes in cancer patients. It can negatively affect prognosis, increase postoperative complications, reduce tolerance to systemic therapy, and impair quality of life. Sarcopenia may be present even in patients with preserved nutritional status or overweight.

This study evaluated the proportion of patients with gastrointestinal cancer who were at risk of sarcopenia, as assessed by the SARC-F screening questionnaire, before initiation of systemic treatment and during treatment. Patients with a positive screening result could be referred for further nutritional evaluation and assessment of sarcopenia severity using anthropometric measurements and DXA, according to standard clinical practice.

详细描述

Sarcopenia is a complex condition characterized by progressive and generalized loss of skeletal muscle mass and strength. In oncology patients, sarcopenia is associated with increased mortality, higher rates of postoperative complications, reduced response to systemic therapy, increased treatment-related toxicity, and decreased quality of life. Sarcopenia may occur independently of malnutrition and may also be present in patients with normal or increased body weight.

Sarcopenia is not only related to the presence of malignant disease but may also develop or worsen as a consequence of oncological treatment. Several antineoplastic therapies have been shown to negatively affect muscle mass and function.

Due to its significant negative clinical impact, early detection of sarcopenia risk is essential. The SARC-F questionnaire is a validated screening tool recommended by the European Working Group on Sarcopenia in Older People (EWGSOP2) for identifying individuals at risk of sarcopenia.

This prospective observational cohort study evaluated the proportion of patients with gastrointestinal cancers treated at the Institute of Oncology Ljubljana who screened positive for sarcopenia risk using the SARC-F questionnaire before initiation of systemic treatment and during treatment. The study also assessed changes in the proportion of patients at risk over time.

Patients with a positive SARC-F screening result could be referred to the Clinical Nutrition Outpatient Clinic for further evaluation, including anthropometric measurements and DXA assessment, in order to determine the severity of sarcopenia. Based on clinical evaluation and in agreement with the treating oncologist, multimodal and multidisciplinary preventive and therapeutic interventions could be introduced as part of routine clinical care.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Adult patients (≥18 years) with gastrointestinal cancer
  • Patients planned for or receiving systemic anticancer treatment (adjuvant treatment or treatment of metastatic disease)
  • Ability to complete the SARC-F screening questionnaire
  • Written informed consent provided

排除标准

  • Patients younger than 18 years
  • Patients unable to complete the questionnaire (e.g., severe cognitive impairment or inability to cooperate)
  • Patients not eligible for systemic anticancer treatment
  • Refusal to participate in the study

研究组 & 干预措施

Gastrointestinal Cancer Patients

Patients with gastrointestinal cancer receiving systemic treatment (adjuvant or metastatic setting) at the Institute of Oncology Ljubljana. Participants will be screened for sarcopenia risk using the SARC-F questionnaire at baseline and during treatment.

干预措施: Sarcopenia Screening and Nutritional Referral (Other)

结局指标

主要结局

Proportion of gastrointestinal cancer patients with positive SARC-F screening

时间窗: Baseline (before start of systemic treatment) and during systemic treatment (after 3 months

Percentage of patients with gastrointestinal cancer who screen positive for sarcopenia risk using the SARC-F questionnaire. A SARC-F score ≥4 will be considered positive.

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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