Resistance Training and Physical Functioning in Head and Neck Cancer Patients

Study Overview
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Brief Summary
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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
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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.

Official Title
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Resistance Training and Physical Functioning in Head and Neck Cancer Patients

Conditions
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Head and Neck Cancer, Pharyngeal Cancer, Laryngeal Cancer

Intervention / Treatment
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* Behavioral: Nutrition Counseling
* Behavioral: Resistance Training and Nutrition Counseling


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 90 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Resistance Training and Nutrition Counseling<br> | Behavioral: Resistance Training and Nutrition Counseling<br>* 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.<br>|
| Other: Nutrition Counseling<br> | Behavioral: Nutrition Counseling<br>* 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.<br>* Other names: nutrition;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| safety of head and neck cancer patients | adverse events | daily (up to 12 weeks) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| change in muscle strength | dynamometer measurement | baseline, week 6, and week 12 | 
| Number of patients who adhere to cohort activity schedule | completion of exercise or diet recommendations | baseline, week 6, and week 12 | 
| change in lean body mass | bioelectrical impedence | baseline, week 6, week 12 | 
| 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 | baseline, week 6, week 12 | 
| change in fatigue level | 13-item Functional Assessment of Cancer Therapy-Fatigue scale | baseline, week 6, week 12 | 
| change in quality of life | 37-item Functional Assessment of Cancer Therapy-Head and Neck scale | baseline, week 6, week 12 | 
| 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 | up to 16 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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head and neck cancer, resistance training, nutrition counseling, pharyngeal or laryngeal cancer