Resistance Training During Radiation Therapy for Pharyngeal or Laryngeal Cancer

• Number of head and neck cancer patients recruited to participate [ Time Frame: up to 16 months ] [ Designated as safety issue: No ]
  to test the feasibility of a randomized controlled exercise trial in head and neck cancer patients receiving radiation therapy
  
  

• change in muscle strength [ Time Frame: baseline, week 6, and week 12 ] [ Designated as safety issue: No ]
  dynamometer measurement
  
  
• Number of patients who adhere to cohort activity schedule [ Time Frame: baseline, week 6, and week 12 ] [ Designated as safety issue: No ]
  completion of exercise or diet recommendations
  
  
• change in lean body mass [ Time Frame: baseline, week 6, week 12 ] [ Designated as safety issue: No ]
  bioelectrical impedence
  
  
• change in physical functioning [ Time Frame: baseline, week 6, week 12 ] [ Designated as safety issue: No ]
  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 ] [ Designated as safety issue: No ]
  13-item Functional Assessment of Cancer Therapy-Fatigue scale
  
  
• change in quality of life [ Time Frame: baseline, week 6, week 12 ] [ Designated as safety issue: No ]
  37-item Functional Assessment of Cancer Therapy-Head and Neck scale
  
  

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.