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Resistance Training During Radiation Therapy for Pharyngeal or Laryngeal Cancer

Phase 2
19 Years
75 Years
Open (Enrolling)
Head and Neck Cancer, Pharyngeal Cancer, Laryngeal Cancer

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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.

Inclusion Criteria

Inclusion criteria:

- 1st time diagnosis of head and neck cancer (stage I, II, III, or IV pharyngeal or

- age 19 to 75 years old

- English speaking

- radiation therapy planned or underway < 1 week

- Karnofsky performance status ≥ 60%, and

- able to stand

Exclusion Criteria:

- 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

Type of Study:


Study Design:

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Supportive Care

Outcome Measure:

Number of head and neck cancer patients recruited to participate

Outcome Description:

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

Outcome Time Frame:

up to 16 months

Safety Issue:


Principal Investigator

Laura Q Rogers, MD, MPH

Investigator Role:

Principal Investigator

Investigator Affiliation:

University of Alabama at Birmingham


United States: Institutional Review Board

Study ID:

ROG-SCCI 09-001-1



Start Date:

January 2011

Completion Date:

December 2014

Related Keywords:

  • Head and Neck Cancer
  • Pharyngeal Cancer
  • Laryngeal Cancer
  • head and neck cancer
  • resistance training
  • nutrition counseling
  • radiation therapy
  • pharyngeal or laryngeal cancer
  • Laryngeal Neoplasms
  • Head and Neck Neoplasms
  • Pharyngeal Neoplasms



University of Alabama at BirminghamBirmingham, Alabama  35294-3300