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

Breast Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05605808
• Other study ID #: P.T.REC/012/003747
• Status: Recruiting
• Phase: N/A
• Start date: May 20, 2022
• Est. completion date: March 28, 2023

Study information

• Verified date: November 2022
• Source: Cairo University
• Contact: Shaimaa MA Elsayeh, PhD
• Phone: +201007766160
• Email: sh.sayeh87[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 60
• Est. completion date: March 28, 2023
• Est. primary completion date: February 21, 2023
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 40 Years to 60 Years

Eligibility

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.

Related Conditions & MeSH terms

• Breast Cancer
• Diet, Healthy
• Immune Deficiency
• Immunologic Deficiency Syndromes

Intervention

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.
• 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.

Locations

Country	Name	City	State
Egypt	Shaimaa Mohamed Ahmed Elsayeh	Cairo	New Cairo

Sponsors (1)

Lead Sponsor	Collaborator
Cairo University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The change in total lymphocyte count.	from patient's blood sample analysis for immunological markers in lab.	Baseline and twelve weeks after the intervention.
Primary	The change in neutrophil to lymphocyte ratio.	from patient's blood sample analysis for immunological markers in lab.	Baseline and twelve weeks after the intervention.
Primary	The change in platelet to lymphocyte ratio.	from patient's blood sample analysis for immunological markers in lab.	Baseline and twelve weeks after the intervention.