Resistance Training During Radiation Therapy for Pharyngeal or Laryngeal Cancer
- Conditions
- Head and Neck CancerPharyngeal CancerLaryngeal Cancer
- Interventions
- Behavioral: Nutrition CounselingBehavioral: Resistance Training
- Registration Number
- NCT00827164
- Lead Sponsor
- University of Alabama at Birmingham
- Brief Summary
The purpose of this feasibility study is to examine the 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 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 29
Not provided
- dementia or organic brain syndrome
- severe emotional distress
- active schizophrenia
- quadriplegia or loss of use of limbs or torso
- tendon rupture
- muscle tear
- 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 Nutrition Counseling 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. Resistance Training Resistance Training Patient will meet with an exercise specialist once per week for the first 6 weeks. Patients 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.
- Primary Outcome Measures
Name Time Method Number of head and neck cancer patients recruited to participate up to 24 months to test the feasibility of a randomized controlled exercise trial in head and neck cancer patients receiving radiation therapy
- Secondary Outcome Measures
Name Time Method 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
Trial Locations
- Locations (1)
University of Alabama at Birmingham
🇺🇸Birmingham, Alabama, United States