Exercise Therapy in Head and Neck Squamous Cell Carcinoma (HNSCC)
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 40
- 主要终点
- Number of Patients that complete TENS unit exercise as recommended
研究概览
简要总结
The goals of this clinical trial are to learn 1. Determine the feasibility of a home-based exercise analog therapy using Transcutaneous Electrical Nerve Stimulation (TENS), 2. Determine the effects of exercise analog therapy on muscle mass, strength, and clinical outcomes, and 3. Determine the effects of exercise analog therapy on immune phenotype and inflammation response in patients undergoing radiation for head and neck squamous cell carcinoma (HNSCC).
The main question it aims to answer are:
Does an exercise regimen using an analog TENS unit during the course of cancer treatment for those with HNSCC improve muscle mass, strength, clinical outcomes and immune response compared to those that do not perform the exercise regimen during their cancer treatment?
Researchers will compare outcomes of patients undergoing cancer treatment + TENS unit exercise to those being treated for their cancer with no exercise TENS unit.
In the exercise arm, subjects will use the TENS unit for 30 minutes of exercise a day, 3 times a week for the extent of their cancer treatments.
Weekly check-ins by phone or less frequently at scheduled in person visits.
Participants will keep a log of their exercise sessions to make sure that the exercise occurs 3 times a week for 30 minutes each and note any reasons why a session may have been missed or time shortened.
Both arms will have a blood draw at the beginning of their cancer treatment and approximately 4 weeks after the last cancer treatment (~40mL). These samples will be tested for molecules that signal a higher or lower immune response with the addition of the exercise in one group compared to the cancer therapy only group.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adult patients (18 years or older)
- •Diagnosed with head and neck squamous cell carcinoma
- •HPV negative
- •Undergoing treatment at OLOL H&N Center
排除标准
- •Any subject less than 18 years of age.
- •Subjects who have HPV positive HNSCC
- •Subjects who have a pacemaker or electronic implant
研究组 & 干预措施
Cancer Treatment Only
Subjects will undergo their prescribed cancer treatment therapy (radiation/chemo/adjuvant)
Cancer Treatment + Exercise TENS therapy
Subjects will undergo prescribed cancer therapy (chemo/radiation/adjuvant) with the addition of an at-home analog TENS unit exercise therapy regimen
干预措施: Exercise (Other)
结局指标
主要结局
Number of Patients that complete TENS unit exercise as recommended
时间窗: beginning of cancer treatment to 4 weeks after cancer treatment concludes
The documentation of successful completion of exercise with the recommended use guidelines (30min, 3 times a week for duration of cancer therapy) will determine if using this type of low maintenance analog exercise muscle stimulation is practical for use in this patient population.
次要结局
- Percent Fat/Water/Muscle Content of Body(Once prior to cancer treatment and once 4 weeks post treatment)
- Body Mass Index (BMI)=Weight (kg)/Height (m)^2(Once at beginning of cancer treatment and once 4 weeks post-cancer treatment)
- Levels/Amount of Immunophenotypic Molecules from Blood Diagnostics (pg/mL)(Beginning of cancer treatment to 4 weeks post-cancer treatment)