Resistance Training During Radiation Therapy for Pharyngeal or Laryngeal Cancer

May 9, 2015 updated by: Laura Q. Rogers, MD, MPH, University of Alabama at Birmingham
The purpose of this feasibility study is to examine the 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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 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.

Study Type

Interventional

Enrollment (Actual)

29

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Alabama
      • Birmingham, Alabama, United States, 35294
        • University of Alabama at Birmingham

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

19 years to 90 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion criteria:

  • 1st time diagnosis of head and neck cancer (stage I, II, III, or IV; pharyngeal, laryngeal, nasopharyngeal, oral, floor of mouth, tongue, palate, maxillary, or mandibular)
  • age 19 to 90 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: SUPPORTIVE_CARE
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Resistance Training
Patient will meet with an exercise specialist once per week for the first 6 weeks. Patients 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.
Behavioral: Resistance Training
Patient will meet with an exercise specialist once per week for the first 6 weeks. Patients 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.
OTHER: Nutrition Counseling
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.
Behavioral: Nutrition Counseling
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.
Other Names:
  • nutrition

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of head and neck cancer patients recruited to participate
Time Frame: up to 24 months
to test the feasibility of a randomized controlled exercise trial in head and neck cancer patients receiving radiation therapy
up to 24 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
change in muscle strength
Time Frame: baseline, week 6, and week 12
dynamometer measurement
baseline, week 6, and week 12
Number of patients who adhere to cohort activity schedule
Time Frame: baseline, week 6, and week 12
completion of exercise or diet recommendations
baseline, week 6, and week 12
change in lean body mass
Time Frame: baseline, week 6, week 12
bioelectrical impedence
baseline, week 6, week 12
change in physical functioning
Time Frame: baseline, week 6, week 12
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
baseline, week 6, week 12
change in fatigue level
Time Frame: baseline, week 6, week 12
13-item Functional Assessment of Cancer Therapy-Fatigue scale
baseline, week 6, week 12
change in quality of life
Time Frame: baseline, week 6, week 12
37-item Functional Assessment of Cancer Therapy-Head and Neck scale
baseline, week 6, week 12

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Alabama at Birmingham

Collaborators

American Institute for Cancer Research

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2011

Primary Completion (ACTUAL)

April 1, 2015

Study Completion (ACTUAL)

April 1, 2015

Study Registration Dates

First Submitted

January 21, 2009

First Submitted That Met QC Criteria

January 21, 2009

First Posted (ESTIMATE)

January 22, 2009

Study Record Updates

Last Update Posted (ESTIMATE)

May 12, 2015

Last Update Submitted That Met QC Criteria

May 9, 2015

Last Verified

May 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ROG-SCCI 09-001-1
  • UAB IRB X121218021 (OTHER_GRANT: American Institute for Cancer Research)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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