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Trial Title:
Aerobic Training and Diet on the Immune System in Postmastectomy Patients Receiving Chemotherapy
NCT ID:
NCT05605808
Condition:
Immune Deficiency
Diet, Healthy
Breast Cancer
Conditions: Official terms:
Immunologic Deficiency Syndromes
Conditions: Keywords:
Aerobic exercises
Diet therapy
Immune function
Mastectomy
Study type:
Interventional
Study phase:
N/A
Overall status:
Unknown status
Study design:
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).
Primary purpose:
Treatment
Masking:
Single (Outcomes Assessor)
Masking description:
Computer randomization.
Intervention:
Intervention type:
Other
Intervention name:
Aerobic exercises
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.
Arm group label:
Aerobic exercises and diet protocol group
Arm group label:
Aerobic exercises group
Intervention type:
Other
Intervention name:
Diet protocol
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.
Arm group label:
Aerobic exercises and diet protocol group
Arm group label:
Diet protocol group
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.
Criteria for 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.
Gender:
Female
Gender based:
Yes
Gender description:
Female patients
Minimum age:
40 Years
Maximum age:
60 Years
Healthy volunteers:
No
Locations:
Facility:
Name:
Shaimaa Mohamed Ahmed Elsayeh
Address:
City:
Cairo
Zip:
02
Country:
Egypt
Status:
Recruiting
Contact:
Last name:
Shaimaa MA Elsayeh, PhD
Phone:
01007766160
Email:
shaimaa.elsayeh@cu.edu.eg
Investigator:
Last name:
Esraa T Mohamed, BSC
Email:
Principal Investigator
Investigator:
Last name:
Nancy H Aboelnour, PhD
Email:
Principal Investigator
Start date:
May 20, 2022
Completion date:
March 28, 2023
Lead sponsor:
Agency:
Cairo University
Agency class:
Other
Source:
Cairo University
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05605808
