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Clinical Trials/NCT01332682
NCT01332682
Completed
Phase 1

Resistance Training and Physical Functioning in Head and Neck Cancer Patients

University of Alabama at Birmingham1 site in 1 country18 target enrollmentMarch 2009

Overview

Phase
Phase 1
Intervention
Not specified
Conditions
Head and Neck Cancer
Sponsor
University of Alabama at Birmingham
Enrollment
18
Locations
1
Primary Endpoint
safety of head and neck cancer patients
Status
Completed
Last Updated
2 years ago

Overview

Brief 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.

Registry
clinicaltrials.gov
Start Date
March 2009
End Date
December 2012
Last Updated
2 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Laura Q. Rogers, MD, MPH

Professor

University of Alabama at Birmingham

Eligibility Criteria

Inclusion Criteria

  • Not provided

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
  • cancer recurrence
  • another diagnoses of cancer in the past 5 years, and
  • oncologist refuses to allow screening for possible study participation

Outcomes

Primary Outcomes

safety of head and neck cancer patients

Time Frame: daily (up to 12 weeks)

adverse events

Secondary Outcomes

  • change in lean body mass(baseline, week 6, week 12)
  • change in physical functioning(baseline, week 6, week 12)
  • change in fatigue level(baseline, week 6, week 12)
  • change in quality of life(baseline, week 6, week 12)
  • Number of head and neck cancer patients recruited to participate(up to 16 months)
  • change in muscle strength(baseline, week 6, and week 12)
  • Number of patients who adhere to cohort activity schedule(baseline, week 6, and week 12)

Study Sites (1)

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