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Resistance Training During Radiation Therapy for Pharyngeal or Laryngeal Cancer

Primary Purpose

Head and Neck Cancer, Pharyngeal Cancer, Laryngeal Cancer

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Nutrition Counseling
Resistance Training
Sponsored by
University of Alabama at Birmingham
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Head and Neck Cancer focused on measuring head and neck cancer, resistance training, nutrition counseling, radiation therapy, pharyngeal or laryngeal cancer

Eligibility Criteria

19 Years - 90 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • University of Alabama at Birmingham

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Other

Arm Label

Resistance Training

Nutrition Counseling

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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

Full Information

First Posted
January 21, 2009
Last Updated
May 9, 2015
Sponsor
University of Alabama at Birmingham
Collaborators
American Institute for Cancer Research
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1. Study Identification

Unique Protocol Identification Number
NCT00827164
Brief Title
Resistance Training During Radiation Therapy for Pharyngeal or Laryngeal Cancer
Official Title
Resistance Training During Radiation Therapy for Pharyngeal or Laryngeal Cancer
Study Type
Interventional

2. Study Status

Record Verification Date
May 2015
Overall Recruitment Status
Completed
Study Start Date
January 2011 (undefined)
Primary Completion Date
April 2015 (Actual)
Study Completion Date
April 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Alabama at Birmingham
Collaborators
American Institute for Cancer Research

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Head and Neck Cancer, Pharyngeal Cancer, Laryngeal Cancer
Keywords
head and neck cancer, resistance training, nutrition counseling, radiation therapy, pharyngeal or laryngeal cancer

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
29 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Resistance Training
Arm Type
Experimental
Arm Description
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.
Arm Title
Nutrition Counseling
Arm Type
Other
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Nutrition Counseling
Other Intervention Name(s)
nutrition
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Resistance Training
Intervention Description
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.
Primary Outcome Measure Information:
Title
Number of head and neck cancer patients recruited to participate
Description
to test the feasibility of a randomized controlled exercise trial in head and neck cancer patients receiving radiation therapy
Time Frame
up to 24 months
Secondary Outcome Measure Information:
Title
change in muscle strength
Description
dynamometer measurement
Time Frame
baseline, week 6, and week 12
Title
Number of patients who adhere to cohort activity schedule
Description
completion of exercise or diet recommendations
Time Frame
baseline, week 6, and week 12
Title
change in lean body mass
Description
bioelectrical impedence
Time Frame
baseline, week 6, week 12
Title
change in physical functioning
Description
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
Time Frame
baseline, week 6, week 12
Title
change in fatigue level
Description
13-item Functional Assessment of Cancer Therapy-Fatigue scale
Time Frame
baseline, week 6, week 12
Title
change in quality of life
Description
37-item Functional Assessment of Cancer Therapy-Head and Neck scale
Time Frame
baseline, week 6, week 12

10. Eligibility

Sex
All
Minimum Age & Unit of Time
19 Years
Maximum Age & Unit of Time
90 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Laura Q Rogers, MD, MPH
Organizational Affiliation
University of Alabama at Birmingham
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Alabama at Birmingham
City
Birmingham
State/Province
Alabama
ZIP/Postal Code
35294
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
19360748
Citation
Rogers LQ, Rao K, Malone J, Kandula P, Ronen O, Markwell SJ, Courneya KS, Robbins KT. Factors associated with quality of life in outpatients with head and neck cancer 6 months after diagnosis. Head Neck. 2009 Sep;31(9):1207-14. doi: 10.1002/hed.21084.
Results Reference
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PubMed Identifier
19340875
Citation
Rogers LQ, Malone J, Rao K, Courneya KS, Fogleman A, Tippey A, Markwell SJ, Robbins KT. Exercise preferences among patients with head and neck cancer: prevalence and associations with quality of life, symptom severity, depression, and rural residence. Head Neck. 2009 Aug;31(8):994-1005. doi: 10.1002/hed.21053.
Results Reference
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Resistance Training During Radiation Therapy for Pharyngeal or Laryngeal Cancer

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