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临床试验/NCT05890859
NCT05890859已完成不适用

Lean Body Mass in Head and Neck Cancer Patients During Cisplatin-based Chemoradiation

Department of Public Health, Denmark2 个研究点 分布在 1 个国家目标入组 48 人开始时间: 2015年4月5日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
48
试验地点
2
主要终点
Lean body mass

研究概览

简要总结

The goal of this clinical trial is to investigate the changes in body composition in head and neck cancer patients during treatment. The main questions it aims to answer are: What is the rate of lean body mass loss and how is it associated with changes in muscle strength and functional performance? Is the lean body mass loss impacted by adding chemotherapy to the radiation treatment? Participants will be asked to undergo five body composition scans during treatment and undergo tests for muscle strength and functional performance before and after treatment.

详细描述

The primary aim of the present study is to investigate the rate of decline in body composition (LBM, body weight and fat mass) as well as changes in maximal muscle strength and functional performance during radiation treatment in HNSCC patients and to investigate the association between the loss of LBM and impairments in maximal muscle strength and functional performance. Secondly, the study investigates whether adding cisplatin during chemoradiation induces exacerbated LBM loss compared to radiation alone.

50 patients are expected to be included in the study. Inclusion criteria are: (1) histologically proven squamous cell carcinoma of the larynx, pharynx, or oral cavity, (2) prescribed to radical or post-operative radiotherapy of at least 60 Gy with or without concomitant chemotherapy. Exclusion criteria were palliative radiation or participation in competing research protocols.

Five times during treatment (biweekly), patients will be asked to undergo a Dual Energy X-ray Absorptiometry scan to evaluate changes in lean body mass and fat mass. Before and after treatment patients are asked to perform three test for maximal muscle strength (one repetition maximum knee extension, chest press and leg press) as well as three functional performance test (30 s arm curl, 30 s chair rise and stair climb).

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Diagnostic
盲法
None

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

  • Histologically proven squamous cell carcinoma of the larynx, pharynx, or oral cavity
  • Prescribed to radical or post-operative radiotherapy of at least 60 Gy with or without concomitant chemotherapy

排除标准

  • Palliative radiation or participation in competing research protocols

结局指标

主要结局

Lean body mass

时间窗: Bi-weekly from treatment start to two weeks post treatment (5 scans in total)

Lean body mass in kg determined by DXA scans

次要结局

  • Fat mass(Bi-weekly from treatment start to two weeks post treatment (5 scans in total))

研究者

发起方
Department of Public Health, Denmark
申办方类型
Other
责任方
Principal Investigator
主要研究者

Simon Lønbro

PhD

Department of Public Health, Denmark

研究点 (2)

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