Benefits of Resistance Exercise Training in Locally Advanced Head and Neck Cancer Patients Undergoing Organ-Preserving Definitive Therapy
Overview
- Phase
- Not Applicable
- Status
- Completed
- Enrollment
- 24
- Locations
- 2
- Primary Endpoint
- The effect of resistance exercise training (RET) versus usual care (UC) on the preservation of lean body mass.
Overview
Brief Summary
The purpose of this study is to evaluate the potential benefit of an individualized resistance exercise-training program during radiotherapy for patients with locally advanced head and neck cancer.
Detailed Description
Patients with locally advanced head and neck cancer are treated with radiation therapy (with/without chemotherapy) to avoid large surgical procedures. However, definitive radiation treatments can cause side effects (like mouth sores, difficulty swallowing) that often cause weight loss. It has been shown that a significant percentage of the weight loss is due to loss of muscle mass. Resistance exercise training works to increase muscle strength and endurance by doing repetitive exercises with weights, weight machines, or resistance bands.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Patients with American Joint Committee on Cancer (AJCC) stage II-IV head and neck squamous cell carcinoma who are beginning first-line non-surgical treatment with radiotherapy (with or without chemotherapy or targeted agents), and who are capable of understanding and adhering to the protocol requirements.
- •Patients must be willing to comply with the study procedures and visits
Exclusion Criteria
- •Active cardiopulmonary disease
- •Substantial dementia (based on Folstein Mini Mental State Examination \<24 out of 30)
- •Acute medical conditions, such as acute flare-up of joint condition or infection
- •Participants must not be actively receiving physical therapy, at time of enrollment, or actively exercising 2 or more hours a day, with the intent to continue that regimen
- •Patients refusing a percutaneous endoscopic gastrotomy (PEG) Tube needed for nutrition, as determined necessary by treating physician
- •Patients are actively being treated for another cancer at the time of enrollment.
Outcomes
Primary Outcomes
The effect of resistance exercise training (RET) versus usual care (UC) on the preservation of lean body mass.
Time Frame: 14 weeks
Lean body mass will be analyzed at baseline, 3, 5, and 7-weeks (representing the last week of cancer treatment and end of on-site RET), 11-weeks (first clinic follow-up) and 14-weeks (second clinic follow-up and end of home-based RET program) for patients on both arms of the study.
Secondary Outcomes
- The effect of resistance exercise training (RET) versus usual care (UC) on the preservation of muscle strength.(14 weeks)
- The effect of resistance exercise training (RET) versus usual care (UC) on six minute walk distance(14 weeks)