Trial Information

Resistance Training During Radiation Therapy for Pharyngeal or Laryngeal Cancer

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.