NCT05418842已完成不适用
Exercise Prehabilitation in Patients With Head and Neck Squamous-cell Carcinoma: The FIT4TREAT Trial
Associacao de Investigacao de Cuidados de Suporte em Oncologia10 个研究点 分布在 1 个国家目标入组 47 人开始时间: 2021年5月28日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 47
- 试验地点
- 10
- 主要终点
- Functional Capacity
研究概览
简要总结
The main purpose of this randomized-controlled trial is to evaluate the effects of prehabilitation based on exercise training (ET) on functional capacity in HNC patients treated with chemoradiotherapy (CRT). Forty-six participants will be randomized (1:1 ratio) into prehabilitation and usual care groups. The length of intervention will be at least 2 weeks. Data will be collected at diagnosis, immediately before anti-cancer treatment start and 4 weeks following CRT. Primary outcome is functional capacity as assessed by the six-minute walk test. Additional measures include muscle strength, endothelial function, arterial stiffness, inflammatory biomarkers, body composition, quality of life, treatment tolerance, compliance to treatment, progression-free survival, and overall survival.
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
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age ≥18 years old;
- •Histologically confirmed HNSCC located on the oral cavity, larynx, oropharynx, hypopharynx, nasopharynx or in lymph nodes from an unknown primary tumor (stage I-IV);
- •Proposed for concomitant chemoradiotherapy with curative intent;
- •Date of treatment beginning ≥2 weeks from baseline assessment;
- •ECOG-Performance Status 0-1.
排除标准
- •Completion of previous anticancer treatment within less than a year;
- •Uncontrolled hypertension, cardiac or pulmonary disease;
- •Contraindications to exercise training;
- •Inability to provide informed consent;
- •Expected inability to fulfil the proposed schedule.
结局指标
主要结局
Functional Capacity
时间窗: Change from Baseline (at diagnosis) to 1-3 days before the beginning of radiotherapy
Assessed by six-minute walk test.
次要结局
- Functional Capacity(Change from 1-3 days before the beginning of radiotherapy to 4 Weeks after last radiotherapy session)
- Unplanned hospital visits(From baseline to 4 Weeks after last radiotherapy session)
- Compliance to Chemotherapy(Through chemotherapy completion, an average of 7 weeks)
- Compliance to Radiotherapy(Through radiotherapy completion, an average of 7 weeks)
- Overall Survival(From baseline to 5 years after diagnosis)
- Arterial Stiffness(Change from 1-3 days before the beginning of radiotherapy to 4 Weeks after last radiotherapy session)
- Endothelial Function(Change from 1-3 days before the beginning of radiotherapy to 4 Weeks after last radiotherapy session)
- Lower Limb Functionality(Change from 1-3 days before the beginning of radiotherapy to 4 Weeks after last radiotherapy session)
- Health-related Quality of Life(Change from 1-3 days before the beginning of radiotherapy to 4 Weeks after last radiotherapy session)
- Body Weight(Change from 1-3 days before the beginning of radiotherapy to 4 Weeks after last radiotherapy session)
- Percentage of Body Fat(Change from 1-3 days before the beginning of radiotherapy to 4 Weeks after last radiotherapy session)
- C-Reactive Protein(Change from 1-3 days before the beginning of radiotherapy to 4 Weeks after last radiotherapy session)
- Albumin(Change from 1-3 days before the beginning of radiotherapy to 4 Weeks after last radiotherapy session)
- Hemogram(Change from 1-3 days before the beginning of radiotherapy to 4 Weeks after last radiotherapy session)
- Isometric Handgrip Muscle Strength(Change from 1-3 days before the beginning of radiotherapy to 4 Weeks after last radiotherapy session)
- Head and Neck Cancer-specific Quality of Life(Change from 1-3 days before the beginning of radiotherapy to 4 Weeks after last radiotherapy session)
- Muscle Mass(Change from 1-3 days before the beginning of radiotherapy to 4 Weeks after last radiotherapy session)
- Body Mass Index(Change from 1-3 days before the beginning of radiotherapy to 4 Weeks after last radiotherapy session)
- Treatment-Related Adverse Events(From the beginning of radiotherapy/chemotherapy to 4 Weeks after last radiotherapy session)
- Progression-Free Survival(From baseline to 5 years after diagnosis)
研究者
研究点 (10)
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