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

NCT ID: NCT05605808

Last Updated: 2022-11-04

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-05-20

Study Completion Date

2023-03-28

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.

Conditions

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Immune Deficiency Diet, Healthy Breast Cancer

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

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).
Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors
Computer randomization.

Study Groups

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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.

Group Type EXPERIMENTAL

Aerobic exercises

Intervention Type 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.

Diet protocol

Intervention Type 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.

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.

Group Type ACTIVE_COMPARATOR

Diet protocol

Intervention Type 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.

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.

Group Type ACTIVE_COMPARATOR

Aerobic exercises

Intervention Type 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.

Interventions

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Aerobic exercises

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.

Intervention Type OTHER

Diet protocol

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.

Intervention Type OTHER

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.
Minimum Eligible Age

40 Years

Maximum Eligible Age

60 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Cairo University

OTHER

Sponsor Role lead

Responsible Party

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Shaimaa Mohamed Ahmed Elsayeh

Lecturer of physical therapy

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Shaimaa MA Elsayeh, PhD

Role: STUDY_DIRECTOR

Cairo University

Locations

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Shaimaa Mohamed Ahmed Elsayeh

Cairo, New Cairo, Egypt

Site Status RECRUITING

Countries

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Egypt

Central Contacts

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Shaimaa MA Elsayeh, PhD

Role: CONTACT

+201007766160

Facility Contacts

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Shaimaa MA Elsayeh, PhD

Role: primary

01007766160

Other Identifiers

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P.T.REC/012/003747

Identifier Type: -

Identifier Source: org_study_id

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