Resistance Training and Physical Functioning in Head and Neck Cancer Patients
|ClinicalTrials.gov Identifier: NCT01332682|
Recruitment Status : Completed
First Posted : April 11, 2011
Last Update Posted : May 12, 2015
|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|
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 Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||18 participants|
|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 :||March 2009|
|Actual Primary Completion Date :||December 2010|
|Actual Study Completion Date :||December 2012|
|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.
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
- safety of head and neck cancer patients [ Time Frame: daily (up to 12 weeks) ]adverse events
- change in muscle strength [ Time Frame: baseline, week 6, and week 12 ]dynamometer measurement
- Number of patients who adhere to cohort activity schedule [ Time Frame: baseline, week 6, and week 12 ]completion of exercise or diet recommendations
- change in lean body mass [ Time Frame: baseline, week 6, week 12 ]bioelectrical impedence
- change in physical functioning [ Time Frame: 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 [ Time Frame: baseline, week 6, week 12 ]13-item Functional Assessment of Cancer Therapy-Fatigue scale
- change in quality of life [ Time Frame: 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 [ Time Frame: up to 16 months ]to test the feasibility of a randomized controlled exercise trial in head and neck cancer patients receiving radiation therapy
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01332682
|United States, Illinois|
|Southern Illinois University School of Medicine|
|Springfield, Illinois, United States, 62702|
|Principal Investigator:||Laura Q Rogers, MD, MPH||Southern Illinois University School of Medicine|