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Clinical Trials/NCT05605808
NCT05605808
Recruiting
Not Applicable

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

Cairo University1 site in 1 country60 target enrollmentMay 20, 2022

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Immune Deficiency
Sponsor
Cairo University
Enrollment
60
Locations
1
Primary Endpoint
The change in total lymphocyte count.
Status
Recruiting
Last Updated
3 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
May 20, 2022
End Date
March 28, 2023
Last Updated
3 years ago
Study Type
Interventional
Study Design
Parallel
Sex
Female

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Shaimaa Mohamed Ahmed Elsayeh

Lecturer of physical therapy

Cairo University

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.

Outcomes

Primary Outcomes

The change in total lymphocyte count.

Time Frame: 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.

Time Frame: 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.

Time Frame: Baseline and twelve weeks after the intervention.

from patient's blood sample analysis for immunological markers in lab.

Study Sites (1)

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