Trial record 5 of 161 for:    Open Studies | "Pharyngeal Neoplasms"

Resistance Training During Radiation Therapy for Pharyngeal or Laryngeal Cancer

This study is currently recruiting participants.
Verified January 2014 by University of Alabama at Birmingham
Sponsor:
Collaborator:
American Institute for Cancer Research
Information provided by (Responsible Party):
Laura Q. Rogers, MD, MPH, University of Alabama at Birmingham
ClinicalTrials.gov Identifier:
NCT00827164
First received: January 21, 2009
Last updated: January 3, 2014
Last verified: January 2014
  Purpose

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.


Condition Intervention Phase
Head and Neck Cancer
Pharyngeal Cancer
Laryngeal Cancer
Behavioral: Nutrition Counseling
Behavioral: Resistance Training
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Supportive Care
Official Title: Resistance Training During Radiation Therapy for Pharyngeal or Laryngeal Cancer

Resource links provided by NLM:


Further study details as provided by University of Alabama at Birmingham:

Primary Outcome Measures:
  • Number of head and neck cancer patients recruited to participate [ Time Frame: up to 24 months ] [ Designated as safety issue: No ]
    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 [ Time Frame: baseline, week 6, and week 12 ] [ Designated as safety issue: No ]
    dynamometer measurement

  • Number of patients who adhere to cohort activity schedule [ Time Frame: baseline, week 6, and week 12 ] [ Designated as safety issue: No ]
    completion of exercise or diet recommendations

  • change in lean body mass [ Time Frame: baseline, week 6, week 12 ] [ Designated as safety issue: No ]
    bioelectrical impedence

  • change in physical functioning [ Time Frame: baseline, week 6, week 12 ] [ Designated as safety issue: No ]
    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 [ Time Frame: baseline, week 6, week 12 ] [ Designated as safety issue: No ]
    13-item Functional Assessment of Cancer Therapy-Fatigue scale

  • change in quality of life [ Time Frame: baseline, week 6, week 12 ] [ Designated as safety issue: No ]
    37-item Functional Assessment of Cancer Therapy-Head and Neck scale


Estimated Enrollment: 44
Study Start Date: January 2011
Estimated Study Completion Date: December 2014
Estimated Primary Completion Date: May 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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 Name: resistance training
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 Name: nutrition

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.

  Eligibility

Ages Eligible for Study:   19 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion criteria:

  • 1st time diagnosis of head and neck cancer (stage I, II, III, or IV pharyngeal or laryngeal)
  • 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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00827164

Contacts
Contact: Courtney Blair, MA 205-975-1247 court9@uab.edu

Locations
United States, Alabama
University of Alabama at Birmingham Recruiting
Birmingham, Alabama, United States, 35294
Principal Investigator: Laura Q. Rogers, MD, MPH         
Sponsors and Collaborators
University of Alabama at Birmingham
American Institute for Cancer Research
Investigators
Principal Investigator: Laura Q Rogers, MD, MPH University of Alabama at Birmingham
  More Information

Publications:
Responsible Party: Laura Q. Rogers, MD, MPH, Professor, University of Alabama at Birmingham
ClinicalTrials.gov Identifier: NCT00827164     History of Changes
Other Study ID Numbers: ROG-SCCI 09-001-1, UAB IRB X121218021
Study First Received: January 21, 2009
Last Updated: January 3, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by University of Alabama at Birmingham:
head and neck cancer
resistance training
nutrition counseling
radiation therapy
pharyngeal or laryngeal cancer

Additional relevant MeSH terms:
Pharyngeal Neoplasms
Laryngeal Neoplasms
Head and Neck Neoplasms
Otorhinolaryngologic Neoplasms
Neoplasms by Site
Neoplasms
Laryngeal Diseases
Respiratory Tract Diseases
Respiratory Tract Neoplasms
Otorhinolaryngologic Diseases
Pharyngeal Diseases
Stomatognathic Diseases

ClinicalTrials.gov processed this record on April 15, 2014