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

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

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05605808
Enrollment
60
Registered
2022-11-04
Start date
2022-05-20
Completion date
2023-03-28
Last updated
2022-11-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Breast Cancer, Diet, Healthy, Immune Deficiency

Keywords

Aerobic exercises, Diet therapy, Immune function, Mastectomy

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.

Interventions

OTHERAerobic 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.

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.

Sponsors

Cairo University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)

Masking description

Computer randomization.

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).

Eligibility

Sex/Gender
FEMALE
Age
40 Years to 60 Years
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
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.

Countries

Egypt

Contacts

Primary ContactShaimaa MA Elsayeh, PhD
sh.sayeh87@gmail.com+201007766160

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026