Feasibility Study: Physical Activity Program Associated Wtih Nutrition Therapeutic Education in Head and Neck Cancer Population Treating by Chemotherapy With or Without Radiotherapy.
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 发起方
- 入组人数
- 10
- 试验地点
- 4
- 主要终点
- feasibility of the APA with a composite outcome measure
研究概览
简要总结
The purpose of this study is to examine the feasibility of resistance training and physical functioning associated with nutrition therapeutic education in head and neck cancer patients, during their treatment (chemotherapy with or without radiotherapy).
详细描述
The loss of muscle mass (i.e., sarcopenia) has been identified as a negative prognosis descriptor, disregarding the type of cancer. It is also a predictive descriptor for treatment-related toxicity. Therefore it appears crucial to save muscle mass of patients, following an adequate physical training together with a personalised diet program. The latter point is of major importance as malnutrition concerns 45% patients having head and neck cancer cancer, who stop physical activity due to extreme tiredness and decrease of quality of life. In the present project, we plan a physical activity program that would be adapted to each patient, accompanied by the rethought diet over a 3-month period. The adapted physical activity (APA) is constituted of two aerobic stages and one resistance training stage per a week. The evaluation will then proceed at three different moments, namely (i) at T0 i.e., beginning of the program, (ii) at 3 months i.e., when the program will be stopped, and (iii) at 6 months i.e., three months after the program stop. This evaluation will include the success rate, the level of satisfaction, the physiological parameters (VO2max, muscle mass and strength, BMI) and quality of life.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Prevention
- 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
- •Age>18 years
- •Written informed consent provided before any study specific procedures
- •Consent to cooperate for clinical assessments
- •Affiliation to a social security regime or beneficiary of equivalent social protection
- •Performance status between 0 and 2
- •Squamous cell carcinoma of oral cavity, oropharynx or hypopharynx
- •Stage III - IV (T1-T4, N0-N3, M)(UICC 2002)
- •Indication of radiotherapy and chemotherapy post-operative or first-line metastatic chemotherapy or in inoperable condition
- •Ability to understand the nature, goal and study methodology
排除标准
- •Prior neoadjuvant chemotherapy
- •timed vital capacity< 70%
- •Presence of another severe pathology including:
- •severe or chronic cardiac, pulmonary, renal and/or hepatic insufficiencies
- •Cons-indication to physical activity practice, at discretion of the investigator
- •Patient under guardianship
- •Psychological, social, geographical, or familial reasons prohibiting physical activity and follow-up
- •Any other primary tumor during the last 5 years
- •Pregnant or nursing
结局指标
主要结局
feasibility of the APA with a composite outcome measure
时间窗: 3 months
The evaluation criteria for the PA program will be: * The success rate that will be reached if 80% of physical exercises will be performed by the patient, over the 3-month period, * The level of satisfaction that will be evaluated with questionnaires filled by the patient.
次要结局
- Evaluation of the personalised diet program and the therapeutic education with a composite outcome measure.(3 months)