Feasibility Study of a Yoga Intervention in Head and Neck Cancer Patients Undergoing Concurrent Chemo-Radiation
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 19
- 试验地点
- 2
- 主要终点
- Safety of Hatha yoga
研究概览
简要总结
This is a randomized prospective pilot study assessing the safety and feasibility of two yoga interventions in head and neck cancer patients undergoing primary or adjuvant radiation with or without concurrent chemotherapy
详细描述
Primary Objective:
- To assess the safety and feasibility of Hatha yoga in head and neck cancer patients undergoing treatment with primary or adjuvant radiation with or without chemotherapy.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 21 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Locally advanced, non-metastatic, histologically confirmed malignancy involving the head and neck region
- •o Larynx, pharynx, oral cavity, salivary gland, paranasal sinuses and unknown primary
- •Age greater or equal to 21 years of age
- •Planned for either definitive or adjuvant radiation therapy with or without chemotherapy
- •o Patients may have received induction chemotherapy or primary surgical resection prior to proceeding to radiation therapy
- •Ability to understand English
- •Daily access to the internet
- •Willing and able to sign informed consent
- •Willing and able to participate in yoga sessions as outlined in the study protocol
- •Exclusion criteria:
- •Prior head and neck cancer radiation
- •Patients who in the opinion of the treating physician are physically, medically or psychologically impaired to the point that participation is not deemed appropriate or feasible
排除标准
- 未提供
结局指标
主要结局
Safety of Hatha yoga
时间窗: Approximately 8 weeks
Number of adverse events as graded by CTCAE 4.0
Feasibility of Hatha yoga
时间窗: Approximately 8 weeks
At least 50% of patients will need to moderately compliant to be feasible (Compliance will be defined as:Fully Compliant: Participation in at least 1 yoga activity on at least 70% of days on study; Moderately Compliant: Participation in at least 1 yoga activity on at least 40% of days on study;Noncompliant: Participation on less than 40% of days on study)
次要结局
未报告次要终点
研究者
Barbara Murphy, MD
Sponsor Investigator
Vanderbilt-Ingram Cancer Center