Feasibility and Preliminary Efficacy of Aerobic Exercise in Head and Neck Cancer Patients Undergoing Radiation Therapy
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 试验地点
- 2
- 主要终点
- Qualitative Feasibility Log of Recruitment of Participants
研究概览
简要总结
Treated head and neck cancer patients are subject to tissue swelling and scarring, known as lymphedema and fibrosis (LEF). LEF in the head and neck cancer patient occurs in up to 90% of treated patients and is associated with inflammation cells. Aerobic exercise is known to mediate these same inflammatory cells in an anti-inflammatory manner due to chronic adaptation of the cells. The investigators are therefore proposing a prescription exercise study for head and neck cancer patients. This study's primary aim is feasibility and safety of the aerobic exercise prescription. Feasibility of gathering study participant inflammation markers, visible LEF, and patient LEF symptoms will be a secondary aim of the study. Patient will be asked to journal their experience for a qualitative analysis. The prescription aerobic exercise is that of high intensity interval exercise, since this form of exercise can achieve similar or better results to moderate exercise with less time and patient burden. Each exercise session will take place on a cycle ergometer, will be 5 minutes warm up, 5 minutes cool down, and 20 minutes of exercise (1 minute intervals alternated by 1 minute rests x 10 each).
详细描述
Treated head and neck cancer patients are subject to tissue swelling and scarring, known as lymphedema and fibrosis (LEF). LEF in the head and neck cancer patient occurs in up to 90% of treated patients, is associated with inflammation cells. Aerobic exercise is known to mediate these same inflammatory cells in an anti-inflammatory manner due to chronic adaptation of the cells. The investigators are therefore proposing a prescription exercise study for head and neck cancer patients. This study's primary aim is feasibility and safety. Feasibility of gathering study participant inflammation markers, visible LEF, and patient LEF symptoms will be a secondary aim of the study. Patient will be asked to journal their experience for a qualitative analysis.
Based on the evidence, the aerobic exercise prescription for those who provide informed consent will consist of 10 intervals of intensity, and 10 intervals at rest. Each interval of intensity will be 1 minutes long and each rest period will be 1 minute long, and there will be a five-minute warm-up and five-minute cool down of easy pedaling for a total of 30 minutes. Participants will complete two sessions per week, and there will be at least one business day in between each session, for a total of 10 total exercise sessions. The total study duration will be less than 35 days.
The supervised prescribed HIIE intervention will be performed on a stationary cycle ergometer. A cycle ergometer is preferred for safety reasons since it requires less gross motor coordination than might be required with a treadmill. To assist in establishing safety (primary aim), the study participants heart rate will be continually monitored by a clinician during the exercise, guiding them to keep their heart rate within their specifically calculated 80-95% of their maximum HR during the periods of intensity.
The investigators will compare outcomes at baseline with outcomes at the end of the 5-week study period.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 100 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •18 years of age
- •Histologic proof of primary diagnosis of head and neck cancer
- •Follow routinely with primary care doctor/general practitioner as evidenced by proof of appointment within the last 24 months)
- •Ability to understand English in order to understand instructions and complete questionnaires
- •Willing to participate in the supervised exercise intervention
- •In the planning stages of/or actively receiving IMRT
- •Must sign study-specific informed consent
- •Medical clearance by attending physician
排除标准
- •Evidence of distant metastasis prior to enrollment
- •Simultaneous primaries or unknown primary
- •Medical conditions that would prohibit the safe implementation of a an aerobic exercise practice per ACSM guidelines: cardiovascular disease, pulmonary disease, metabolic disease, or renal disease or signs/symptoms suggestive of cardiovascular disease at rest or during activity which include pain, discomfort in the chest, neck (other than caused by malignancy), jaw, arms, or other areas that may result from ischemia; shortness of breath at rest or with mild exertion; dizziness or syncope; orthopnea or paroxysmal nocturnal dyspnea; ankle edema; palpitations or tachycardia; intermittent claudication; known heart murmur; or unusual fatigue or shortness of breath with usual activities
- •An answer of "no" on any of the Physical Activity Readiness Questionnaire (PAR-Q+) screening questions
- •Pregnant or lactating women
结局指标
主要结局
Qualitative Feasibility Log of Recruitment of Participants
时间窗: 6 months
To assess the feasibility of recruitment of a prescribed HIIE aerobic exercise modality for HNC patients. This will be measured by a Researchers Log which will include qualitative information regarding noted barriers to recruitment and reasons for patients not participating
Safety of the intervention as noted by parameters for serum bloodwork
时间窗: 6 months
To determine the safety of a prescribed HIIE aerobic exercise modality for HNC patients. This will be measured by a Researchers Log to ensure predetermined labs and electrolytes (platelets, magnesium, phosphorus, potassium) are within study parameter limits each week.
Safety of the intervention as noted by parameters for vitals signs prior to participation
时间窗: 6 months
To determine the safety of a prescribed HIIE aerobic exercise modality for HNC patients. This will be measured by a Researchers Log which will include ensuring vitals signs (heart rate in beats per minute, blood pressure in mmHg, oxygen in saturation, respiration rate in rate per minutes, and temperature in celsius) are within study parameter limits
Quantified and Qualitative Log of Feasibility of Implementation
时间窗: 6 months
To investigate the feasibility of a prescribed HIIE aerobic exercise modality for HNC patients. This will be measured by a Researchers Log which will include reasons that participants may have missed any of their assigned exercise sessions, as well as how many times they missed it.
Quantified and Qualitative Retention Log of Participants
时间窗: 6 months
To assess retention of a prescribed HIIE aerobic exercise modality for HNC patient. This will be measured by a Researchers Log which will include information such as number of participants enrolled, number of participants who dropped out, and reason for drop-out if available
Safety of the intervention as noted by a timely log of adverse events,
时间窗: 6 months
To determine the safety of a prescribed HIIE aerobic exercise modality for HNC patients. This will be measured by a Researchers Log which will include information such as measured by the CTCAE adverse events reported in accordance with and to the IRB
次要结局
- Feasibility of Collecting Bloodwork - Biomarker MMP-9(6 months)
- Feasibility of Collecting Bloodwork at two time points - Biomarker IL-1β(6 months)
- Feasibility of Collecting Bloodwork at two time points - Biomarker TNF-α(6 months)
- Feasibility of Collecting Bloodwork at two time points - TGF-β1(6 months)
- Feasibility of Collecting Bloodwork at two time points - Biomarker IL-6(6 months)
- Feasibility of Collecting Patient Reported Outcome at two time points(6 months)
- Feasibility of Clinician Outcome at two time points(6 months)
- Qualitative data on Patient Experience(6 months)