Resistance Training and Physical Functioning in Head and Neck Cancer Patients
Condition: Head and Neck Cancer; Pharyngeal Cancer; Laryngeal Cancer
MeSH terms: Head and Neck Neoplasms; Laryngeal Neoplasms; Pharyngeal Neoplasms
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this feasibility study is to examine the safety and 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 description: 
      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 safety and
      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.
    

Intervention name(s): Nutrition Counseling; Resistance Training and Nutrition Counseling
Intervention type(s): Behavioral; Behavioral
Intervention description(s): Patients will meet once per week with dietitian for the first 6 weeks in 60 minute sessions. Dietitian will telephone each patient weekly for the final 6 weeks of counseling and support.; Patient will meet with an exercise specialist once per week for the first 6 weeks. Patient will receive guidance in a safe and appropriate exercise regimen based on specific medical history and preference. An exercise specialist will telephone weekly for consultation and support once per week for the final 6 weeks. Also, patient will meet once per week with dietitian for the first 6 weeks in 60 minute sessions. Dietitian will telephone each patient weekly for the final 6 weeks of counseling and support.
Other intervention name(s): nutrition
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Supportive Care
Keywords: head and neck cancer; resistance training; nutrition counseling; pharyngeal or laryngeal cancer