Aerobic Training and Diet on the Immune System in Postmastectomy Patients Receiving Chemotherapy

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Impact of Aerobic Training Combed With Diet Protocol on Immune System in Post Mastectomy Patients Receiving Chemotherapy

Conditions
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Immune Deficiency, Diet, Healthy, Breast Cancer

Intervention / Treatment
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* Other: Aerobic exercises
* Other: Diet protocol


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 Exclusion Criteria: Cardiac disease patients. Uncontrolled hypertension patients. Patients with thyroid disease. Patients with lymphatic complications.

Ages Eligible for Study
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Minimum Age: 40 Years
Maximum Age: 60 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: The model is composed of the aerobic and diet protocol group (Group A), the diet protocol group (Group B), and the aerobic training group (Group C).
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Aerobic exercises and diet protocol group<br>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. | Other: Aerobic exercises<br>* Aerobic exercise by using the 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 in weeks 2-12.<br>Other: Diet protocol<br>* A specific diet for three months is designed to boost the immune system through edible seeds and nuts which are rich in proteins, fats, fibers, minerals, and vitamins.<br>|
| Active Comparator: Diet protocol group<br>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. | Other: Diet protocol<br>* A specific diet for three months is designed to boost the immune system through edible seeds and nuts which are rich in proteins, fats, fibers, minerals, and vitamins.<br>|
| Active Comparator: Aerobic exercises group<br>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. | Other: Aerobic exercises<br>* Aerobic exercise by using the 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 in weeks 2-12.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The change in total lymphocyte count. | from patient's blood sample analysis for immunological markers in lab. | Baseline and twelve weeks after the intervention. | 
| The change in neutrophil to lymphocyte ratio. | from patient's blood sample analysis for immunological markers in lab. | Baseline and twelve weeks after the intervention. | 
| The change in platelet to lymphocyte ratio. | from patient's blood sample analysis for immunological markers in lab. | Baseline and twelve weeks after the intervention. | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Aerobic exercises, Diet therapy, Immune function, Mastectomy