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

NCT05605808 | Unknown

• 1 other identifier: P.T.REC/012/003747
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

Immune Deficiency; Diet, Healthy; Breast Cancer

Keywords

Aerobic exercises; Diet therapy; Immune function; Mastectomy

Outcome Measures

Primary Outcomes (3)

• The change in total lymphocyte count.

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

  Baseline and twelve weeks after the intervention.

• 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.

• 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.

Study Arms (3)

Aerobic exercises and diet protocol group

EXPERIMENTAL

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.

Other: Aerobic exercises; Other: Diet protocol

Diet protocol group

ACTIVE COMPARATOR

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.

Other: Diet protocol

Aerobic exercises group

ACTIVE COMPARATOR

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.

Other: Aerobic exercises

Interventions

Aerobic exercises OTHER

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.

Aerobic exercises and diet protocol group; Aerobic exercises group

Diet protocol OTHER

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.

Aerobic exercises and diet protocol group; Diet protocol group

Eligibility Criteria

• Age: 40 Years - 60 Years
• Gender Eligibility Details: Female patients
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• Cardiac disease patients.
• Uncontrolled hypertension patients.
• Patients with thyroid disease.
• Patients with lymphatic complications.

Sponsors & Collaborators

• Cairo University: lead

Study Sites (1)

Shaimaa Mohamed Ahmed Elsayeh

Cairo, New Cairo, 02, Egypt

RECRUITING

MeSH Terms

Conditions

Immunologic Deficiency Syndromes; Breast Neoplasms

Interventions

Exercise

Condition Hierarchy (Ancestors)

Immune System Diseases; Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Study Officials

• Shaimaa MA Elsayeh, PhD

  Cairo University

  STUDY DIRECTOR

Central Study Contacts

Shaimaa MA Elsayeh, PhD

CONTACT

+201007766160; sh.sayeh87@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Computer randomization.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Lecturer of physical therapy

Model Details: 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).

Study Record Dates

• First Submitted: October 8, 2022
• First Posted: November 4, 2022
• Study Start: May 20, 2022
• Primary Completion: February 21, 2023
• Study Completion: March 28, 2023
• Last Updated: November 4, 2022

Record last verified: 2022-11

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)