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

Cairo University (CU)

Status: Enrolling

Conditions: Breast Cancer; Diet, Healthy; Immune Deficiency

Treatments: Other: Diet protocol; Other: Aerobic exercises

Study type: Interventional

Funder types: Other

Identifiers

NCT05605808

P.T.REC/012/003747

Details and patient eligibility

About

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.

Full 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.

Enrollment: 60 estimated patients

Sex: Female

Ages: 40 to 60 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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60 participants in 3 patient groups

Aerobic exercises and diet protocol group

Experimental group

Description:

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.

Treatment:

Other: Aerobic exercises

Other: Diet protocol

Diet protocol group

Active Comparator group

Description:

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.

Treatment:

Other: Diet protocol

Aerobic exercises group

Active Comparator group

Description:

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.

Treatment:

Other: Aerobic exercises