Clinical Trial: Resistance Training During Radiation Therapy for Pharyngeal or Laryngeal Cancer

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

Official Title: Resistance Training During Radiation Therapy for Pharyngeal or Laryngeal Cancer

Brief Summary: 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.

Detailed Summary:

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 amon
Sponsor: University of Alabama at Birmingham

Current Primary Outcome: Number of head and neck cancer patients recruited to participate [ Time Frame: up to 24 months ]

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


Original Primary Outcome: to determine the feasibility of using a resistance training and nutritional counseling intervention in head and neck cancer patients, including study acceptance, recruitment rates, intervention process evaluation, and adherence [ Time Frame: March 2009 - January 2011 ]

Current Secondary Outcome:

  • change in muscle strength [ Time Frame: baseline, week 6, and week 12 ]
    dynamometer measurement
  • Number of patients who adhere to cohort activity schedule [ Time Frame: baseline, week 6, and week 12 ]
    completion of exercise or diet recommendations
  • change in lean body mass [ Time Frame: baseline, week 6, week 12 ]
    bioelectrical impedence
  • change in physical functioning [ Time Frame: baseline, week 6, week 12 ]
    physical performance by doing a semi-tandem, tandem, or side by side stance with the feet, an 8 foot walk time, and 5 chair rise and sits
  • change in fatigue level [ Time Frame: baseline, week 6, week 12 ]
    13-item Functional Assessment of Cancer Therapy-Fatigue scale
  • change in quality of life [ Time Frame: baseline, week 6, week 12 ]
    37-item Functional Assessment of Cancer Therapy-Head and Neck scale


Original Secondary Outcome: to compare the effect of resistance training plus nutritional counseling versus nutritional counseling alone on muscle strength, lean body mass, physical functioning, fatigue, and quality of life in head and neck patients [ Time Frame: March 2009 - January 2011 ]

Information By: University of Alabama at Birmingham

Dates:
Date Received: January 21, 2009
Date Started: January 2011
Date Completion:
Last Updated: May 9, 2015
Last Verified: May 2015