Impact of Cross-training on Induction Treatment Response in Acute Lymphoblastic Leukemia Adults
试验速览
- 阶段
- 不适用
- 入组人数
- 114
- 试验地点
- 1
- 主要终点
- Platelets count
研究概览
简要总结
Despite advances in the treatment of acute lymphoblastic leukemia, the prognosis in adults is still poor, largely due to the resistance of treatment at diagnosis or early relapse. Among the strategies associated with the treatment of Acute Lymphoblastic Leukemia is rehabilitation and physical medicine in order to improve the quality of life, body composition, fitness, strength and improve the attachment and acceptance of their treatment
详细描述
Previous evidence had shown that among the beneficial effects of an exercise intervention in cancer is the reduction of adverse events associated with treatment, such as nausea and fatigue. Also, the overexpression of Interleukin-15 in cancer is related to a poor prognosis, biologically the implementation of a cross-training exercise routine can function as a regulatory pathway for its expression due to its consumption at muscular level. Finally, the time to consider a relapse with a very poor prognosis is during first three months of treatment, so implementation of an exercise strategy during this period could reduce the proportion of early relapses mediated by Interleukin-15 expression
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Investigator)
盲法说明
The masking of the study will be for the principal investigator, only knowing the maneuver person in charge of the routine and the patient. The patients who will practice the exercise intervention will be carry out in certain space and time that does not interfere with the medical intervention and in which the treating medical personnel will not be present.
入排标准
- 年龄范围
- 18 Years 至 39 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Ability to walk without support.
- •Life expectancy greater than 7 days
- •Previous authorization of treating hematologist for participation
- •Acceptance and signing of informed consent form
排除标准
- •Patients with neutropenia, infections and / or bleeding on admission to hospitalization.
- •Patients that are unable to perform physical activity.
- •Central nervous system diseases that make movement impossible.
- •Cardiac function alterations assessed by electrocardiogram and echocardiogram
- •Patients in relapse
- •Patients referred from another hospital and who are been attended in our hospital
研究组 & 干预措施
Standard Care Group
Each patient will receive the standard pharmacological treatment for patients with Acute Lymphoblastic Leukemia based on 3 cycles of chemotherapy (21 days duration per cycle); plus the World Health Organization recommendation that indicates at least 150 min a week of moderate physical activity, equivalent to walking 30 minutes a day for 5 days at an intensity between 60 and 70% of your maximum heart rate.
Resistance Training Group
Each patient will receive the standard pharmacological treatment for patients with Acute Lymphoblastic Leukemia based on 3 cycles of chemotherapy (21 days duration per cycle); plus a resistance exercise routine using weights. An individualized program with exercises supervised by a trainer and basic medical team will be developed for each patient during their hospital stay. Each training routine will have a monthly exercise progression based on intensity, frequency and / or duration.
干预措施: Training (Other)
Cross-training Group
Each patient will receive the standard pharmacological treatment for patients with Acute Lymphoblastic Leukemia based on 3 cycles of chemotherapy (21 days duration per cycle); plus a cross-training routine using implements without any extra weight to improve stability, joint mobility and general strength of the body. An individualized program with exercises supervised by a trainer and basic medical team will be developed for each patient during their hospital stay. Each training routine will have a monthly exercise progression based on intensity, frequency and / or duration.
干预措施: Training (Other)
结局指标
主要结局
Platelets count
时间窗: 3 months
Number of platelets found in peripheral blood at the end of each chemotherapy cycle
Functional Assessment of Cancer Therapy- Leukemia
时间窗: 3 months
Psychological test that evaluates quality of life from four different areas: functional, emotional, social and physical wellness.
Luekocytes count
时间窗: 3 months
Number of leukocytes found in peripheral blood at the end of each chemotherapy cycle
Hemoglobin count
时间窗: 3 months
Number of hemoglobin found in peripheral blood at the end of each chemotherapy cycle
Interleukin 15
时间窗: 3 months
Pro-inflammatory cytokine concentration, measured through peripheral blood
Neutrophils count
时间窗: 3 months
Number of neutrophils found in peripheral blood at the end of each chemotherapy cycle
Blasts in marrow
时间窗: 3 months
Presence of more than 20% of blasts in bone marrow after each chemotherapy cycle.
次要结局
- Hospital Discharge(3 months)
- Admission to ICU(3 months)
- Complications during hospital stay(1 month)
- Hospital Stay(1 month)
研究者
Christian Omar Ramos-Peñafiel, MD, PhD
Principal Investigator
Hospital General de Mexico