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

Primary Purpose

Immune Deficiency, Diet, Healthy, Breast Cancer

Status
Recruiting
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
Aerobic exercises
Diet protocol
Sponsored by
Cairo University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Immune Deficiency focused on measuring Aerobic exercises, Diet therapy, Immune function, Mastectomy

Eligibility Criteria

40 Years - 60 Years (Adult)FemaleDoes not accept 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.

Sites / Locations

  • Shaimaa Mohamed Ahmed ElsayehRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Active Comparator

Active Comparator

Arm Label

Aerobic exercises and diet protocol group

Diet protocol group

Aerobic exercises group

Arm Description

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.

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.

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.

Outcomes

Primary Outcome Measures

The change in total lymphocyte count.
from patient's blood sample analysis for immunological markers in lab.
The change in neutrophil to lymphocyte ratio.
from patient's blood sample analysis for immunological markers in lab.
The change in platelet to lymphocyte ratio.
from patient's blood sample analysis for immunological markers in lab.

Secondary Outcome Measures

Full Information

First Posted
October 8, 2022
Last Updated
November 3, 2022
Sponsor
Cairo University
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1. Study Identification

Unique Protocol Identification Number
NCT05605808
Brief Title
Aerobic Training and Diet on the Immune System in Postmastectomy Patients Receiving Chemotherapy
Official Title
Impact of Aerobic Training Combed With Diet Protocol on Immune System in Post Mastectomy Patients Receiving Chemotherapy
Study Type
Interventional

2. Study Status

Record Verification Date
November 2022
Overall Recruitment Status
Recruiting
Study Start Date
May 20, 2022 (Actual)
Primary Completion Date
February 21, 2023 (Anticipated)
Study Completion Date
March 28, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Cairo University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Immune Deficiency, Diet, Healthy, Breast Cancer
Keywords
Aerobic exercises, Diet therapy, Immune function, Mastectomy

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
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).
Masking
Outcomes Assessor
Masking Description
Computer randomization.
Allocation
Randomized
Enrollment
60 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Aerobic exercises and diet protocol group
Arm Type
Experimental
Arm Description
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.
Arm Title
Diet protocol group
Arm Type
Active Comparator
Arm Description
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.
Arm Title
Aerobic exercises group
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
Aerobic exercises
Intervention Description
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
Intervention Name(s)
Diet protocol
Intervention Description
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.
Primary Outcome Measure Information:
Title
The change in total lymphocyte count.
Description
from patient's blood sample analysis for immunological markers in lab.
Time Frame
Baseline and twelve weeks after the intervention.
Title
The change in neutrophil to lymphocyte ratio.
Description
from patient's blood sample analysis for immunological markers in lab.
Time Frame
Baseline and twelve weeks after the intervention.
Title
The change in platelet to lymphocyte ratio.
Description
from patient's blood sample analysis for immunological markers in lab.
Time Frame
Baseline and twelve weeks after the intervention.

10. Eligibility

Sex
Female
Gender Based
Yes
Gender Eligibility Description
Female patients
Minimum Age & Unit of Time
40 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Shaimaa MA Elsayeh, PhD
Phone
+201007766160
Email
sh.sayeh87@gmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Shaimaa MA Elsayeh, PhD
Organizational Affiliation
Cairo University
Official's Role
Study Director
Facility Information:
Facility Name
Shaimaa Mohamed Ahmed Elsayeh
City
Cairo
State/Province
New Cairo
ZIP/Postal Code
02
Country
Egypt
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Shaimaa MA Elsayeh, PhD
Phone
01007766160
Email
shaimaa.elsayeh@cu.edu.eg
First Name & Middle Initial & Last Name & Degree
Esraa T Mohamed, BSC
First Name & Middle Initial & Last Name & Degree
Nancy H Aboelnour, PhD

12. IPD Sharing Statement

Plan to Share IPD
No

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

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