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临床试验/NCT00827164
NCT00827164已完成2 期

Resistance Training During Radiation Therapy for Pharyngeal or Laryngeal Cancer

University of Alabama at Birmingham2 个研究点 分布在 1 个国家目标入组 29 人开始时间: 2011年1月最近更新:
适应症

试验速览

阶段
2 期
状态
已完成
入组人数
29
试验地点
2
主要终点
Number of head and neck cancer patients recruited to participate

研究概览

简要总结

The purpose of this feasibility study is to examine the effect of resistance training on muscle strength, lean body mass, physical functioning, fatigue, and quality of life in head and neck cancer patients receiving radiation therapy.

详细描述

Head and neck cancer (HNCa) patients often lose significant body weight and lean mass which is associated with higher mortality, greater fatigue, poorer quality of life, and reduced physical functioning. Because nutritional supplementation may not consistently improve lean body mass, resistance training may be beneficial. HNCa patients experience unique side effects that impact nutritional status, limiting generalization of exercise intervention study results in other cancer types to HNCa patients. Therefore, 44 HNCa patients will be enrolled in a randomized controlled trial with the following study aims:

Primary study aim: Because this pilot proposal is among the first to attempt a randomized controlled exercise trial in HNCa patients, the primary study aim examines feasibility (e.g., study acceptance, recruitment, intervention process evaluation, adherence, adverse events, retention). The investigators hypothesize that study procedures will require minor alterations in future studies.

Secondary study aim #1: Because effect sizes are necessary for planning efficacy trials, the proposal will compare the effect of a 12-week resistance training plus nutritional counseling intervention versus nutritional counseling alone on muscle strength, lean body mass, physical functioning, fatigue, and quality of life in HNCa patients receiving radiation with or without chemotherapy. The investigators hypothesize that patients receiving resistance training with nutritional counseling will demonstrate greater improvements in the outcomes when compared with participants receiving nutritional counseling alone.

Secondary study aim #2: To enhance adherence in future intervention trials, this proposal will determine resistance training and nutritional adherence rates and associated factors among HNCa patients using attendance records, exercise logs, diet records, self-administered survey, and medical record review. The investigators hypothesize that adherence rates will be lower than that of other cancer populations with correlates including demographic, medical, and psychosocial factors.

Assessments will occur at baseline (first week of radiation), week 6 (mid-intervention), and week 12 (post-intervention). Qualitative and quantitative (e.g., rates, 95% confidence intervals) will assess feasibility and mixed model ANOVA will examine group differences. This information is critical for the design of future resistance training efficacy trials in HNCa patients to prevent lean body mass loss in HNCa patients, potentially reducing mortality, minimizing fatigue, and improving physical functioning and quality of life.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Supportive Care
盲法
None

入排标准

年龄范围
19 Years 至 90 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 未提供

排除标准

  • dementia or organic brain syndrome
  • severe emotional distress
  • active schizophrenia
  • quadriplegia or loss of use of limbs or torso
  • tendon rupture
  • muscle tear
  • another diagnoses of cancer in the past 5 years, and
  • oncologist refuses to allow screening for possible study participation

结局指标

主要结局

Number of head and neck cancer patients recruited to participate

时间窗: up to 24 months

to test the feasibility of a randomized controlled exercise trial in head and neck cancer patients receiving radiation therapy

次要结局

  • change in muscle strength(baseline, week 6, and week 12)
  • Number of patients who adhere to cohort activity schedule(baseline, week 6, and week 12)
  • change in lean body mass(baseline, week 6, week 12)
  • change in physical functioning(baseline, week 6, week 12)
  • change in fatigue level(baseline, week 6, week 12)
  • change in quality of life(baseline, week 6, week 12)

研究者

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

Laura Q. Rogers, MD, MPH

Professor

University of Alabama at Birmingham

研究点 (2)

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