Resistance Training and Physical Functioning in Head and Neck Cancer Patients

Phase 1

Completed

• Conditions: Head and Neck Cancer; Pharyngeal Cancer; Laryngeal Cancer
• Interventions: Behavioral: Resistance Training and Nutrition Counseling; Behavioral: Nutrition Counseling

• Registration Number: NCT01332682
• Lead Sponsor: University of Alabama at Birmingham

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.

Study Timeline

• Study Start: 2009-03
• Primary Completion: 2010-12
• Study First Submitted: 2011-04-07
• Study First Submitted QC: 2011-04-08
• Study First Posted: 2011-04-11
• Study Completion: 2012-12
• Status Verified: 2023-10
• Last Update Submitted: 2023-10-17
• Last Update Posted: 2023-10-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 18

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Resistance Training and Nutrition Counseling	Resistance Training and Nutrition Counseling	-
Nutrition Counseling	Nutrition Counseling	-

Primary Outcome Measures

Name	Time	Method
safety of head and neck cancer patients	daily (up to 12 weeks)	adverse events

Secondary Outcome Measures

Name	Time	Method
change in lean body mass	baseline, week 6, week 12	bioelectrical impedence
change in physical functioning	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
change in fatigue level	baseline, week 6, week 12	13-item Functional Assessment of Cancer Therapy-Fatigue scale
change in quality of life	baseline, week 6, week 12	37-item Functional Assessment of Cancer Therapy-Head and Neck scale
Number of head and neck cancer patients recruited to participate	up to 16 months	to test the feasibility of a randomized controlled exercise trial in head and neck cancer patients receiving radiation therapy
change in muscle strength	baseline, week 6, and week 12	dynamometer measurement
Number of patients who adhere to cohort activity schedule	baseline, week 6, and week 12	completion of exercise or diet recommendations

Trial Locations

Locations (1)

Southern Illinois University School of Medicine; 🇺🇸 Springfield, Illinois, United States