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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Aerobic exercises and diet protocol group | Experimental | 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. |
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| Diet protocol group | Active Comparator | 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. |
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| Aerobic exercises group | Active Comparator | 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Aerobic exercises | Other | 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. |
| 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. |
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Inclusion Criteria:
Exclusion Criteria:
Female patients
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Shaimaa MA Elsayeh, PhD | Contact | +201007766160 | sh.sayeh87@gmail.com |
| Name | Affiliation | Role |
|---|---|---|
| Shaimaa MA Elsayeh, PhD | Cairo University | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Shaimaa Mohamed Ahmed Elsayeh | Recruiting | Cairo | New Cairo | 02 | Egypt |
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| ID | Term |
|---|---|
| D007153 | Immunologic Deficiency Syndromes |
| D001943 | Breast Neoplasms |
| ID | Term |
|---|---|
| D007154 | Immune System Diseases |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D001941 | Breast Diseases |
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| ID | Term |
|---|---|
| D015444 | Exercise |
| ID | Term |
|---|---|
| D009043 | Motor Activity |
| D009068 | Movement |
| D009142 | Musculoskeletal Physiological Phenomena |
| D055687 | Musculoskeletal and Neural Physiological Phenomena |
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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).
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Computer randomization.
| Diet protocol | Other | 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. |
|
| D012871 |
| Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |