Resistance Training and Physical Functioning in Head and Neck Cancer Patients

Sponsor

University of Alabama at Birmingham (Other)

Overall Status

Completed

CT.gov ID

NCT01332682

Collaborator

(none)

Enrollment

Location

Arms

Duration (Months)

0.4

Patients Per Site Per Month

Study Details

Study Description

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.

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

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 Design

Study Type:

Interventional

Actual Enrollment :

18 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Supportive Care

Official Title:

Resistance Training and Physical Functioning in Head and Neck Cancer Patients

Study Start Date :

Mar 1, 2009

Actual Primary Completion Date :

Dec 1, 2010

Actual Study Completion Date :

Dec 1, 2012

Arms and Interventions

Arm	Intervention/Treatment
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: 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 Names: nutrition

Arm

Intervention/Treatment

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: 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 Names:

nutrition

Outcome Measures

Primary Outcome Measures

safety of head and neck cancer patients [daily (up to 12 weeks)]
adverse events

Secondary Outcome Measures

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
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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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