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

Sponsor

Cairo University (Other)

Overall Status

Recruiting

CT.gov ID

NCT05605808

Collaborator

(none)

Enrollment

Location

Arms

10.3

Anticipated Duration (Months)

5.9

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Immune Deficiency Diet, Healthy Breast Cancer	Other: Aerobic exercises Other: Diet protocol	N/A

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 Design

Study Type:

Interventional

Anticipated Enrollment :

60 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Intervention 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).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 (Outcomes Assessor)

Masking Description:

Computer randomization.

Primary Purpose:

Treatment

Official Title:

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

Actual Study Start Date :

May 20, 2022

Anticipated Primary Completion Date :

Feb 21, 2023

Anticipated Study Completion Date :

Mar 28, 2023

Arms and Interventions

Arm	Intervention/Treatment
Experimental: 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.	Other: 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. 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.
Active Comparator: 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.	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.
Active Comparator: 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.	Other: 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.

Arm

Intervention/Treatment

Experimental: 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.

Other: 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.

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.

Active Comparator: 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.

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.

Active Comparator: Aerobic exercises group

Other: Aerobic exercises

Outcome Measures

Primary Outcome Measures

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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

40 Years to 60 Years

Sexes Eligible for Study:

Female

Accepts Healthy Volunteers:

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Shaimaa Mohamed Ahmed Elsayeh	Cairo	New Cairo	Egypt	02

Sponsors and Collaborators

Cairo University

Investigators

Study Director: Shaimaa MA Elsayeh, PhD, Cairo University

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Shaimaa Mohamed Ahmed Elsayeh, Lecturer of physical therapy, Cairo University

ClinicalTrials.gov Identifier:

NCT05605808

Other Study ID Numbers:

P.T.REC/012/003747

First Posted:

Nov 4, 2022

Last Update Posted:

Nov 4, 2022

Last Verified:

Nov 1, 2022

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by Shaimaa Mohamed Ahmed Elsayeh, Lecturer of physical therapy, Cairo University

Additional relevant MeSH terms:

Immunologic Deficiency Syndromes

Study Results

No Results Posted as of Nov 4, 2022