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Progressive Resistance Training Program in Head and Neck Cancer Patients

2015年9月23日 更新者:Julie Gehl、Herlev Hospital

Feasibility of a 12-week Progressive Resistance Training Program in Head and Neck Cancer Patients During Concurrent Radiochemotherapy - a Pilot Trial

The purpose of this study is to evaluate the feasibility of a 12-week progressive resistance training (PRT) during concurrent chemoradiotherapy in head and neck cancer patients compared to usual care.

研究概览

地位

完全的

条件

详细说明

12 patients with head and neck cancer will be recruited to this trial. Entering a 12-week PRT program which will start one week before radiotherapy. The tested training program is a 12-week, supervised, group based, progressive resistance training program involving the major muscle groups of the body. The program has previously been found to successfully restore the loss of lean body mass (LBM) in head and neck cancer patients post-treatment. A group based approach will be used to facilitate a social and motivating training environment for the patients. This approach has previously been used for exercise interventions for lung cancer patients at our facility, and was highly appreciated by the patients.

In addition to baseline data (height, tumor stage, performance status, etc), the following parameters will be registered on a weekly basis: Weight, patient reported side effects, as well as a questionnaire on amount of physical activity and food intake.

Physical function and strength will be tested at baseline, after the course of chemoradiotherapy and at the end of the 12-week PRT programme, and at 2, 5, 9 and 13 months follow-up. At similar time points dual energy x-ray absorptiometry (DXA) scans for body composition will be performed using a Lunar iDXA (GE Healthcare).

Blood samples will be drawn at baseline, an additional three times during the first 6 weeks and then weekly in relation to training sessions, and at 2, 5, 9 and 13 months follow-up.

Patient reported quality of life (EORTC Quality of Life Questionaire (QLQ)-C30 and QLQ-H&N35) will be registered at baseline, after 12-weeks PRT and during 5 and 13 months follow-up.

Study duration is expected to be 7 months for the pilot-trial, with a follow-up of additional 13 months after the last patient has completed the intervention.

研究类型

介入性

注册 (实际的)

12

阶段

  • 不适用

联系人和位置

本节提供了进行研究的人员的详细联系信息,以及有关进行该研究的地点的信息。

学习地点

      • Herlev、丹麦、2730
        • Dept. of oncology

参与标准

研究人员寻找符合特定描述的人,称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

18年 及以上 (成人、年长者)

接受健康志愿者

不

有资格学习的性别

全部

描述

Inclusion Criteria:

  • Patients with head and neck squamous cell carcinoma
  • Candidates for concomitant chemoradiotherapy according to Danish Head and Neck Cancer Group (DAHANCA) guidelines.
  • Performance status 0-1
  • Expected to be able to complete the intervention, i.e. no major comorbidities or social issues that could compromise attendance.
  • At least 18 years of age.

学习计划

本节提供研究计划的详细信息,包括研究的设计方式和研究的衡量标准。

研究是如何设计的?

设计细节

  • 分配:不适用
  • 介入模型:单组作业
  • 屏蔽:无(打开标签)

武器和干预

参与者组/臂
干预/治疗
其他:Progressive resistance training
12 weeks, 3 sessions per week, 7 exercises (leg press, leg curl, hamstring curl, chest press, lateral pull down, sit-ups and back extensions). In general 2-3 sets of 8-15 repetitions will be performed following a progression plan starting with more repetitions at lower intensity progressing to fewer repetitions at higher intensity during the 12-week period (American College of Sports Medicine Position Stand).
A 12-week, supervised, group based, progressive resistance training program involving the major muscle groups of the body will be tested. Details of the program: 12 weeks, 3 sessions per week, 7 exercises (leg press, leg curl, hamstring curl, chest press, lateral pull down, sit-ups and back extensions). In general 2-3 sets of 8-15 repetitions will be performed following a progression plan starting with more repetitions at lower intensity progressing to fewer repetitions at higher intensity during the 12-week period (American College of Sports Medicine Position Stand)

研究衡量的是什么?

主要结果指标

结果测量
措施说明
大体时间
Feasibility
大体时间:up to 7 months

The feasibility outcomes will be inclusion rate defined as the number of patients recruited from the number of eligible patients and completion rate defined as the number of participants able to complete the intervention.

Adherence to the exercise intervention will be evaluated via patient-reported training logs.

up to 7 months

次要结果测量

结果测量
措施说明
大体时间
Change in LBM
大体时间:up to 20 months
Whole body LBM will be determined using dual energy x-ray absorptiometry (DXA).
up to 20 months
Weight loss
大体时间:up to 20 months
Patient will be weighed weekly during the 12-week PRT program; afterwards at each follow-up (2, 5, 9, and 13 months)
up to 20 months
Number of patients with side-effects to treatment
大体时间:up to 7 months
Side-effects will be registered using Common Terminology Criteria for Advers Events v4.0 (CTCAE).
up to 7 months
Quality of Life
大体时间:Up to 20 months
Up to 20 months
Change in physical function and strength
大体时间:Up to 20 months

Change in muscle strength will be evaluated by 1 repetition maximum test (1RM) measured in kg.

Change in muscle power will be evaluated by Nottingham Power Rig and measured in watts and watt/kg.

Change in physical function will be evaluated by 30 second sit-to-stand test, arm curl test and stair climbing.

Up to 20 months

其他结果措施

结果测量
措施说明
大体时间
Muscle biopsies
大体时间:up to 7 months
In order to establish energy-reserves in the muscles
up to 7 months
Blood samples
大体时间:Up to 20 months
In order to identify systemic factors released during exercise
Up to 20 months

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

调查人员

  • 首席研究员:Julie Gehl, ph.d.、Herlev Hospital

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查,以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始

2014年2月1日

初级完成 (实际的)

2015年9月1日

研究完成 (实际的)

2015年9月1日

研究注册日期

首次提交

2014年2月13日

首先提交符合 QC 标准的

2014年2月20日

首次发布 (估计)

2014年2月21日

研究记录更新

最后更新发布 (估计)

2015年9月25日

上次提交的符合 QC 标准的更新

2015年9月23日

最后验证

2015年9月1日

更多信息

与本研究相关的术语

此信息直接从 clinicaltrials.gov 网站检索,没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求,请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改,我们的网站上也会自动更新.

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