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

Cairo University60 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Enrollment

Conditions

Immune Deficiency Diet, Healthy Breast Cancer

Interventions

Aerobic exercisesOTHER

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.

Diet protocolOTHER

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.

Eligibility

Sex: FEMALEMin age: 40 YearsMax age: 60 Years

Medical Language ↔ Plain English

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.

Locations (1)

Shaimaa Mohamed Ahmed Elsayeh

Cairo, New Cairo, Egypt

RECRUITING

Outcomes

Primary Outcomes

The change in total lymphocyte count.

from patient's blood sample analysis for immunological markers in lab.

Time frame: 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.

Time frame: 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.

Time frame: Baseline and twelve weeks after the intervention.

Central Contacts

Shaimaa MA Elsayeh, PhD

CONTACT

+201007766160 sh.sayeh87@gmail.com

Data from ClinicalTrials.gov

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