Impact of Aerobic Training Combed With Diet Protocol on Immune System in Post Mastectomy Patients Receiving Chemotherapy
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- The change in total lymphocyte count.
研究概览
简要总结
The purpose of the study was to investigate the impact of aerobic exercise combined with diet protocol on the immune system in post-mastectomy patients receiving chemotherapy.
详细描述
Chemotherapy reduces circulating lymphocytes levels, which affect lymphocytes in breast cancer patients during the therapy itself or up to 3 months after the last chemotherapy cycle, so the study is developed to investigate the impact of aerobic exercise combined with diet protocol on the immune system in post-mastectomy patients receiving chemotherapy. Sixty post-mastectomy women were receiving chemotherapy and aged from 40-60 years selected from the outpatient clinic of the oncology department in the New Cairo hospital in the Police Academy. They will be assigned randomly into three equal groups, the aerobic exercises and diet protocol group, the diet protocol group, and the aerobic exercises group. The immunological markers; total lymphocyte count (TLC), neutrophil-to-lymphocyte ratio(NLR), and platelet-to-lymphocyte ratio(PLR) will be measured at baseline and after twelve weeks of intervention.
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 (Outcomes Assessor)
盲法说明
Computer randomization.
入排标准
- 年龄范围
- 40 Years 至 60 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Female post-mastectomy patients.
- •Age range is between 40-60 years old.
- •All patients will enter the study after having their informed consent.
- •All patients are undergoing chemotherapy treatment with AC protocol (Adriamycin with endoxan) for four cycles (every 21 days ).
- •All patients have finished the first stage of chemotherapy treatment
排除标准
- •Cardiac disease patients.
- •Uncontrolled hypertension patients.
- •Patients with thyroid disease.
- •Patients with lymphatic complications.
研究组 & 干预措施
Aerobic exercises and diet protocol group
The participant will be managed by aerobic exercise by using a treadmill, two times per week. Its intensity was equivalent to 60-85% of each patient's maximum heart rate and lasted 20 minutes in the first week and 30 minutes after the second week in addition to the diet protocol specific diet designed to boost the immune system through edible seeds and nuts which are rich in proteins, fats, fibers, minerals, and vitamins for twelve weeks.
干预措施: Aerobic exercises (Other)
Aerobic exercises and diet protocol group
The participant will be managed by aerobic exercise by using a treadmill, two times per week. Its intensity was equivalent to 60-85% of each patient's maximum heart rate and lasted 20 minutes in the first week and 30 minutes after the second week in addition to the diet protocol specific diet designed to boost the immune system through edible seeds and nuts which are rich in proteins, fats, fibers, minerals, and vitamins for twelve weeks.
干预措施: Diet protocol (Other)
Diet protocol group
The participant will be managed by a specific diet protocol designed to boost the immune system through edible seeds and nuts which are rich in proteins, fats, fibers, minerals, and vitamins for twelve weeks.
干预措施: Diet protocol (Other)
Aerobic exercises group
The participant will be managed by aerobic exercise by using a treadmill, two times per week. Its intensity was equivalent to 60-85% of each patient's maximum heart rate and lasted 20 minutes in the first week and 30 minutes after the second week for twelve weeks as a total treatment time.
干预措施: Aerobic exercises (Other)
结局指标
主要结局
The change in total lymphocyte count.
时间窗: Baseline and twelve weeks after the intervention.
from patient's blood sample analysis for immunological markers in lab.
The change in neutrophil to lymphocyte ratio.
时间窗: Baseline and twelve weeks after the intervention.
from patient's blood sample analysis for immunological markers in lab.
The change in platelet to lymphocyte ratio.
时间窗: Baseline and twelve weeks after the intervention.
from patient's blood sample analysis for immunological markers in lab.
次要结局
未报告次要终点
研究者
Shaimaa Mohamed Ahmed Elsayeh
Lecturer of physical therapy
Cairo University