Resistance Training and Physical Functioning in Head and Neck Cancer Patients

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Laura Q. Rogers, MD, MPH, University of Alabama at Birmingham
ClinicalTrials.gov Identifier:
NCT01332682
First received: April 7, 2011
Last updated: June 14, 2014
Last verified: June 2014
  Purpose

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.


Condition Intervention Phase
Head and Neck Cancer
Pharyngeal Cancer
Laryngeal Cancer
Behavioral: Nutrition Counseling
Behavioral: Resistance Training and Nutrition Counseling
Phase 1

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 and Physical Functioning in Head and Neck Cancer Patients

Resource links provided by NLM:


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

Primary Outcome Measures:
  • safety of head and neck cancer patients [ Time Frame: daily (up to 12 weeks) ] [ Designated as safety issue: Yes ]
    adverse events


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

  • Number of head and neck cancer patients recruited to participate [ Time Frame: up to 16 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


Enrollment: 18
Study Start Date: March 2009
Estimated Study Completion Date: December 2015
Primary Completion Date: December 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Resistance Training and Nutrition Counseling Behavioral: Resistance Training and Nutrition Counseling
Patient will meet with an exercise specialist once per week for the first 6 weeks. Patient 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. Also, patient 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: resistance training and nutrition counseling
Nutrition Counseling 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 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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion criteria:

  • cancer of the oral cavity, pharynx, larynx, nasal cavity/sinuses, or salivary gland
  • ≥ 18 years of age
  • English speaking
  • radiation therapy planned or underway < 1 week, 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
  • cancer recurrence
  • another diagnoses of cancer in the past 5 years, and
  • oncologist refuses to allow screening for possible study participation
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01332682

Locations
United States, Illinois
Southern Illinois University School of Medicine
Springfield, Illinois, United States, 62702
Sponsors and Collaborators
University of Alabama at Birmingham
Investigators
Principal Investigator: Laura Q Rogers, MD, MPH Southern Illinois University School of Medicine
  More Information

Additional Information:
Publications:
Responsible Party: Laura Q. Rogers, MD, MPH, Professor, University of Alabama at Birmingham
ClinicalTrials.gov Identifier: NCT01332682     History of Changes
Other Study ID Numbers: SCCI-09-001-A, SCRIHS 07-164
Study First Received: April 7, 2011
Last Updated: June 14, 2014
Health Authority: United States: Institutional Review Board

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

Additional relevant MeSH terms:
Laryngeal Neoplasms
Head and Neck Neoplasms
Pharyngeal 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 July 26, 2014