跳至主要内容
临床试验/NCT06730685
NCT06730685Enrolling By Invitation不适用

PHILUCA: The Development of Muscle Mass, Muscle Strength, and Muscle Function in Patients With Lung Cancer During Cancer Treatment

Zealand University Hospital1 个研究点 分布在 1 个国家目标入组 160 人开始时间: 2024年12月12日最近更新:
适应症

试验速览

阶段
不适用
状态
Enrolling By Invitation
入组人数
160
试验地点
1
主要终点
Overvall survival

研究概览

简要总结

The PHILICA study investigates whether muscle mass, muscle strength, and muscle function are associated with treatment tolerance, quality of life and survival in patients with lung cancer. It also aims to explore why some patients face challenges in completing their treatment. The findings may contribute to improved strategies for supporting patients and developing more precise and individualized treatment plans in the future.

详细描述

The PHILUCA prospective cohort study investigates the relationship between sarcopenia, cachexia, and change in muscle parameters with both treatment tolerance, quality of life and survival in patients with lung cancer receiving systemic treatment(s) (n=160). It aims to identify factors associated with difficulties in completing oncological treatment and to elucidate patterns that may inform improved patient support and individualized treatment planning. The study involves non-invasive physical assessments, patient-reported questionnaires, and the analysis of routinely collected medical data.

Assessments of muscle mass, muscle strength, muscle function, and quality of life are conducted at key time points, including at diagnosis and after three months into treatment or until the first control scan. Physical tests are performed during routine hospital visits, requiring no additional appointments. Body composition analysis is performed using Bioelectrical impedance analysis and by Computed Tomography scans obtained as part of standard care, without additional imaging procedures.

All participants receive standard lung cancer treatment, which may include surgery, chemotherapy, radiation therapy, immunotherapy, targeted therapy, or combinations thereof, based on disease type and stage. The study does not interfere with or modify standard care protocols. Participants unwilling or unable to fully participate may still contribute by completing a baseline questionnaire and consenting to the use of medical record data.

The study seeks to advance the understanding of how muscle-related parameters influence cancer treatment outcomes. The findings are anticipated to inform strategies for optimizing treatment tolerance, improving patient outcomes, and tailoring supportive care interventions for individuals with lung cancer.

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
否

入选标准

  • •Age ≥ 18 years of age
  • •Diagnosed with lung cancer (all types and stages) and scheduled for oncological treatment
  • •More than 3 months expected survival

排除标准

  • •Competing cancer
  • •Pregnancy
  • •Severe physical or cognitive disabilities preventing physical testing and informend consent
  • •Not able to read and understand Danish

结局指标

主要结局

Overvall survival

时间窗: 12 months from inclusion

Death from all causes

次要结局

  • Change in muscle mass(Assessments are intended to be performed around 3 months after inclusion, which in routine clinical practice usually corresponds to the time point immediately before the first control scan.)
  • Change in muscle function(Assessments are intended to be performed around 3 months after inclusion, which in routine clinical practice usually corresponds to the time point immediately before the first control scan.)
  • Change in muscle strength(Assessments are intended to be performed around 3 months after inclusion, which in routine clinical practice usually corresponds to the time point immediately before the first control scan.)
  • Health-Related Quality of Life(Assessments are intended to be performed around 3 months after inclusion, which in routine clinical practice usually corresponds to the time point immediately before the first control scan.)
  • Dose-limiting toxicities (DLT)(6 months from inclusion)
  • Disease-specific symptoms(Assessments are intended to be performed around 3 months after inclusion, which in routine clinical practice usually corresponds to the time point immediately before the first control scan.)
  • Haematological toxicities(6 months from inclusion)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Susanne Dalton

Professor, MD, PhD

Zealand University Hospital

研究点 (1)

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