Immune DeficiencyNCT05605808
Aerobic Training and Diet on the Immune System in Postmastectomy Patients Receiving Chemotherapy
A study testing Aerobic exercises and Diet protocol in people with Immune Deficiency and Diet, Healthy, run by Cairo University at 1 site in Egypt.
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. Read more about this study
- Who is it for?
- Ages 40 to 60 years, women only
- Conditions the study is for
- Immune Deficiency, Diet, Healthy, Breast Cancer
- What is being tested?
- Aerobic exercises and Diet protocol
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteEgypt
- Study dates
- 20 May 2022to 28 Mar 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 to 60 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- 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
Who cannot join
- Cardiac disease patients.
- Uncontrolled hypertension patients.
- Patients with thyroid disease.
- Patients with lymphatic complications.
Trial locations and contacts
1 site in 1 country.
Egypt1 site, 1 recruiting
- Recruiting
Shaimaa Mohamed Ahmed Elsayeh
Cairo, New Cairo, 02
Shaimaa MA Elsayeh, PhD, 01007766160, shaimaa.elsayeh@cu.edu.eg
Esraa T Mohamed, BSC
About this study
Official title: Impact of Aerobic Training Combed With Diet Protocol on Immune System in Post Mastectomy Patients Receiving Chemotherapy
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.
- Conditions
- Immune Deficiency, Diet, Healthy, Breast Cancer
- Being tested
- Aerobic exercises, Diet protocol
- Keywords
- Aerobic exercises, Diet therapy, Immune function, Mastectomy
- Medical subject headings
- Immunologic Deficiency Syndromes, Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Aerobic exercisesOther
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 protocolOther
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: 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. Receives: Other: Aerobic exercises |
What is being measured
The primary outcome is the main question the study is designed to answer.
The change in total lymphocyte count.
from patient's blood sample analysis for immunological markers in lab.
Measured: 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.
Measured: 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.
Measured: Baseline and twelve weeks after the intervention.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Nov 2022
- Study start20 May 2022
- Primary completion21 Feb 2023 (estimated)
- Study completion28 Mar 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Immune DeficiencyStudies of the same condition, open and under way.
- More trials run by Cairo UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 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).
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Shaimaa Mohamed Ahmed Elsayeh, Cairo University
- Investigators
- Shaimaa MA Elsayeh, PhD, Study director, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05605808
- Sponsor's protocol ID
- P.T.REC/012/003747
- Status last verified
- Nov 2022
- First submitted
- 8 Oct 2022
- Last updated
- 4 Nov 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Nov 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Aerobic Training Combed With Diet Protocol on Immune System in Post Mastectomy Patients Receiving Chemotherapy
- ClinicalTrials.gov ID
- NCT05605808
- Acronym / sponsor ID
- P.T.REC/012/003747
- Conditions
- Immune Deficiency, Diet, Healthy, Breast Cancer
- Keywords
- Aerobic exercises, Diet therapy, Immune function, Mastectomy
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 20 May 2022 (actual)
- Primary completion
- 21 Feb 2023 (estimated)
- Study completion
- 28 Mar 2023 (estimated)
- First posted
- 4 Nov 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
- Model description
- 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).
| Arm | Type | Receives |
|---|---|---|
| Aerobic exercises and diet protocol group | Experimental | Other: Aerobic exercises, Other: Diet protocolThe 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. |
| Diet protocol group | Active comparator | Other: Diet protocolThe 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. |
| Aerobic exercises group | Active comparator | Other: Aerobic exercisesThe 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. |
Who may qualify
- Ages
- 40 to 60 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (4 listed)
- Cardiac disease patients.
- Uncontrolled hypertension patients.
- Patients with thyroid disease.
- Patients with lymphatic complications.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Aerobic exercisesAerobic 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. | Other | Aerobic exercises and diet protocol group, Aerobic exercises group |
| Diet protocolA 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. | Other | Aerobic exercises and diet protocol group, Diet protocol group |
Primary outcome
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.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Nov 2022.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Shaimaa MA Elsayeh, PhD study director
Cairo University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Aerobic exercises and Diet protocol in people with Immune Deficiency and Diet, Healthy, run by Cairo University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 4 Nov 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Shaimaa MA Elsayeh, PhD (+201007766160, sh.sayeh87@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The change in total lymphocyte count. (time frame: Baseline and twelve weeks after the intervention.). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Nov 2022.