CClinicalTrials.gg
Status unknownNCT05605808Updated Nov 4, 2022

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

An interventional study of Aerobic exercises and Diet protocol in Immune Deficiency, Diet, Healthy and Breast Cancer, sponsored by Cairo University. Status unknown at 1 site in Egypt. Open to female participants aged 40 Years to 60 Years. Per ClinicalTrials.gov, last updated 2022-11-04.

Sponsored by Cairo University · Not applicable, Interventional, and Treatment

The sponsor has not verified this record recently (last verified Nov 2022), so the status shown — last known as Recruiting — may be out of date.

From the registry’s dates

  • Registered 4 months after the study started (first participant enrolled May 2022, registered Oct 2022).
Phase
Not applicable
Study type
Interventional
Enrollment
60
Allocation
Randomized
Ages
40 Years to 60 Years
Sex
Female
01

Study 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.

Read the 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.

02

Conditions studied

  • Immune Deficiency
  • Diet, Healthy
  • Breast Cancer

Keywords

  • Aerobic exercises
  • Diet therapy
  • Immune function
  • Mastectomy
03

In context

Immunologic Deficiency Syndromes

698 studies on the registry are indexed under Immunologic Deficiency Syndromes; 67 are open to participants now.

This study's planned enrollment of 60 is close to the median of 56 across 455 interventional studies indexed under Immunologic Deficiency Syndromes.

Browse Immunologic Deficiency Syndromes studies →

Lead sponsor

Cairo University is the lead sponsor of 4,780 studies on the registry; 1,427 are open to participants now.

Of its 36 completed or terminated interventional studies of FDA-regulated products, 5 (14%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
40 Years to 60 Years
Sexes eligible
Female
Accepts 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

Exclusion Criteria:

  • Cardiac disease patients.
  • Uncontrolled hypertension patients.
  • Patients with thyroid disease.
  • Patients with lymphatic complications.
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Outcomes assessor)
Enrollment
60 participants (estimated)

Study arms

  • Experimental
    Aerobic exercises and diet protocol group

    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

  • Active comparator
    Diet protocol group

    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

  • Active comparator
    Aerobic exercises group

    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

  • 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.

  • OtherDiet 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.

06

What researchers measure

Primary outcomes

  1. The change in total lymphocyte count.

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

    Time frame: Baseline and twelve weeks after the intervention.

  2. The change in neutrophil to lymphocyte ratio.

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

    Time frame: Baseline and twelve weeks after the intervention.

  3. The change in platelet to lymphocyte ratio.

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

    Time frame: Baseline and twelve weeks after the intervention.

07

Study locations

1 of 1 sites recruiting
  • Shaimaa Mohamed Ahmed Elsayeh
    Cairo, New Cairo 02, Egypt
    • Shaimaa MA Elsayeh, PhD · Contact · shaimaa.elsayeh@cu.edu.eg · 01007766160
    • Esraa T Mohamed, BSC · Principal investigator
    • Nancy H Aboelnour, PhD · Principal investigator
    Recruiting
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Nov 4, 2022, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT05605808
Lead sponsor
Cairo University
Responsible party
Shaimaa Mohamed Ahmed Elsayeh (Lecturer of physical therapy, Cairo University) — Principal investigator
First posted
Nov 4, 2022
Start date
May 20, 2022
Primary completion
Feb 21, 2023 (estimated)
Completion
Mar 28, 2023 (estimated)
Last update
Nov 4, 2022

Study contacts

Shaimaa MA Elsayeh, PhD
Contact
sh.sayeh87@gmail.com
+201007766160
Shaimaa MA Elsayeh, PhD
study director · Cairo University

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Nov 2022. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Start the discussion