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

Not Applicable

Recruiting

• Conditions: Breast Cancer; Immune Deficiency; Diet, Healthy
• Interventions: Other: Aerobic exercises; Other: Diet protocol

• Registration Number: NCT05605808
• Lead Sponsor: Cairo University

Brief Summary

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

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.

Study Timeline

• Study Start: 2022-05-20
• Study First Submitted: 2022-10-08
• Status Verified: 2022-11
• Study First Submitted QC: 2022-11-03
• Last Update Submitted: 2022-11-03
• Study First Posted: 2022-11-04
• Last Update Posted: 2022-11-04
• Primary Completion: 2023-02-21
• Study Completion: 2023-03-28

Recruitment & Eligibility

• Status: RECRUITING
• Sex: Female
• Target Recruitment: 60

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Aerobic exercises and diet protocol group	Aerobic exercises	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.
Aerobic exercises group	Aerobic exercises	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.
Diet protocol group	Diet protocol	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.
Aerobic exercises and diet protocol group	Diet protocol	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.

Primary Outcome Measures

Name	Time	Method
The change in total lymphocyte count.	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.	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.	Baseline and twelve weeks after the intervention.	from patient's blood sample analysis for immunological markers in lab.

Trial Locations

Locations (1)

Shaimaa Mohamed Ahmed Elsayeh; 🇪🇬 Cairo, New Cairo, Egypt