The Effect of Physical Exercise During Radiotherapy on Physical Functioning in Patients With Head and Neck Cancer: a Trial Within Cohorts, the VITAL Study
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 112
- 试验地点
- 1
- 主要终点
- physical performance
研究概览
简要总结
The goal of this trial within cohorts study is to determine and compare physical performance, muscle strength, fatigue, quality of life, body composition, nutritional status, physical activity, treatment tolerability of radiotherapy (RT), chemoradiation (CRT) or bioradiation (BRT), and healthcare related costs in patients with head and neck cancer (HNC) with and without a 10 week physical exercise intervention (PEI) during RT, CRT or BRT ((C/B)RT).
Patients who were randomized in the PEI group and accepted the invitation to undergo the experimental intervention receive a PEI twice a week for 10 weeks. The PEI will be executed 6 to 7 weeks during and 3 to 4 weeks after (C/B)RT.
Researchers will compare patients who undergo the PEI with patients who did not undergo the PEI to see if there is difference in physical performance, muscle strength, fatigue, Quality of Life, body composition, nutritional status, physical activity, treatment tolerability of (C/B)RT , and healthcare related costs in patients with Head and Neck Cancer (HNC) with and without a 10 week Physical Exercise Intervention (PEI) during (C/B)RT).
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
- •patients with HNC who are scheduled for (C/B)RT,
- •≥18 years of age,
- •sufficient Dutch writing and reading skills,
- •a Karnofsky performance status (KPS) >60,
- •able to walk ≥60m without a mobility aid, and
- •no contraindication for physical activity as measured with the physical activity readiness questionnaire (PAR-Q).
排除标准
- •recurrence of HNC and/or
- •secondary HNC.
研究组 & 干预措施
Patients who were randomized in the PEI group and accepted the invitation
The experimental intervention consist of a PEI for 10 weeks. The PEI will be executed 6 to 7 weeks during and 3 to 4 weeks after (C/B)RT.
干预措施: Experimental Intervention (Other)
Patients who were not randomized in the PEI group
Patients will receive usual care.
结局指标
主要结局
physical performance
时间窗: M0 (baseline/before (C/B)RT), M1 (12 weeks), M2 (6 months), M3 (12 months)
six minute walking test
次要结局
- Muscle strength(M0 (baseline/before (C/B)RT), M1 (12 weeks), M2 (6 months), M3 (12 months))
- Health Related Quality of Life(M0 (baseline/before (C/B)RT), M1 (12 weeks), M2 (6 months), M3 (12 months))
- Fatigue(M0 (baseline/before (C/B)RT), M1 (12 weeks), M2 (6 months), M3 (12 months))
- socio-demographic data and medical data(M0 (baseline/before (C/B)RT))
- Nutrition status(M0 (baseline/before (C/B)RT), M1 (12 weeks), M2 (6 months), M3 (12 months))
- Tolerability of radiotherapy, chemoradiation or bioradiation(M1 (12 weeks), M2 (6 months), M3 (12 months))
- Body composition(M0 (baseline/before (C/B)RT), M1 (12 weeks), M2 (6 months), M3 (12 months))
- Physical activity(M0 (baseline/before (C/B)RT), M1 (12 weeks), M2 (6 months), M3 (12 months))