Impact of a Nutritional and Physical Exercise Intervention Program on Oncological Treatment Completion in Patients ≥70 Years Old With Malignant Hemopathies:ICOSENIORHEM Randomized Clinical Trial
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 80
- 试验地点
- 1
- 主要终点
- Adherence to oncological treatment
研究概览
简要总结
Clinical trial to analyze the impact of nutrition and physical exercise intervention program on the completion of treatment in older patients 70 years or older with malignant hemopathology
详细描述
OBJECTIVE:
This study aims to determine wether a geriatric intervention based on an individualized program of physical exercise and nutritional support improves the ability to complete oncological treatment at the doses and time initially planned in patients ≥ 70 years affected by hematological malignancies.
DESIGN:
Prospective, clinical trial, randomized, parallel and open groups.
SETTING:
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
- 70 Years 至 —（Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •hematological pathology (myelodysplastic syndromes, lymphoproliferative syndromes, multiple myeloma)
- •considered able to practice physical exercise
- •signed informed consent
排除标准
- •other hematological pathology
- •considered unable to practice physical exercise
研究组 & 干预措施
Intervention group
Patients in the intervention group will follow the standard treatment and follow-uo according to the clinical protocol of the institution and will participate in an intervention program with physical exercise and nutritional support during the period in which they are receiving oncological treatment or for a maximum period of 6 months.
干预措施: Nutritional support (Other)
Intervention group
Patients in the intervention group will follow the standard treatment and follow-uo according to the clinical protocol of the institution and will participate in an intervention program with physical exercise and nutritional support during the period in which they are receiving oncological treatment or for a maximum period of 6 months.
干预措施: Physical exercise (Other)
Intervention group
Patients in the intervention group will follow the standard treatment and follow-uo according to the clinical protocol of the institution and will participate in an intervention program with physical exercise and nutritional support during the period in which they are receiving oncological treatment or for a maximum period of 6 months.
干预措施: Hematologic Drug (Drug)
Control group
The patients of the control group will follow the standard treatment and follow-up according to the clinical protocol of the institution.
干预措施: Hematologic Drug (Drug)
结局指标
主要结局
Adherence to oncological treatment
时间窗: Change from baseline and after finishing treatment or 6 months
Percentage between the dose administered and the prescribed.
次要结局
- Risk of vulnerability(Baseline versus 6 months (end of intervention) versus 12 months)
- Geriatric assessment(Baseline versus 6 months (end of intervention) versus 12 months)
- Nutritional screening(Baseline versus 6 months (end of intervention) versus 12 months)
- Functional capacity(Baseline versus 6 months (end of intervention) versus 12 months)
- Physical condition screening(Change from baseline versus 6 months (end of intervention) versus 12 months)
- Physical condition tests(Baseline versus 6 months (end of intervention) versus 12 months)
- Body mass index(Baseline versus 6 months (end of intervention) versus 12 months)
- Anthropometric evaluation(Baseline versus 6 months (end of intervention) versus 12 months)
- Body composition(Baseline versus 6 months (end of intervention) versus 12 months)
- Performance of muscular strength(Baseline versus 6 months (end of intervention) versus 12 months)
- Functional capacity assessment(Change from baseline versus 6 months (end of intervention) versus 12 months)
- Assessment of lower limbs strengh(Change from baseline versus 6 months (end of intervention) versus 12 months)
- Average number of exercise sessions completed(Through study completion, an average of 6 months)
- Incidence of adverse effects(Through study completion, an average of 6 months)
- Quality of life Assessment(Change from baseline versus 6 months (end of intervention) versus 12 months)
- Disease progression(Change from baseline and after 2 years)
- Survival(Change from baseline and after 2 years)
研究者
Maite Antonio, MD, Phd
Coordinator Oncohematogeriatrics Unit. Institut Català d'Oncologia
L'Hospitalet de Llobregat