Trace Elements Levels After Breast Cancer RadiotherapyNCT06070155
Effect of Aerobic Exercises on Trace Elements in Post-menopausal Women After Radiotherapy
A study testing Aerobic Exercise three time a week in people with Trace Elements Levels After Breast Cancer Radiotherapy, run by Cairo University at 1 site in Egypt.
Trial summary
This study will be conducted on 28 participants who are survivors of breast cancer and underwent radiotherapy. The purpose of the current study is to investigate the effect of aerobic exercises on quality of life and serum levels of Zinc, Copper and iron in post-menopausal women who received radiotherapy after… Read more about this study
- Who is it for?
- Ages 50 to 60 years, women only
- Conditions the study is for
- Trace Elements Levels After Breast Cancer Radiotherapy
- What is being tested?
- Aerobic Exercise three time a week
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 28 participants
- Where
- 1 siteEgypt
- Study dates
- 10 Oct 2023to 17 Jan 2026
- 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 50 to 60 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- All postmenopausal women with breast cancer and received radiotherapy immediately at the end of radiotherapy or max six months to one year in each group. after clinically diagnosed by Oncologist with breast cancer Stage I and II .
- Their ages will range from 50-60 years old.
- Good general Health (ECOG performance status 0-1).
- Voluntary acceptance of participation in the study.
Who cannot join
- Systematic chronic diseases (respiratory diseases, cardiovascular diseases…etc)
- Cognitive dysfunction as well as neuromuscular or musculoskeletal impairment or disease affecting postural control or motion pattern.
- Professional athletes.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effect of Aerobic Exercises on Some Trace Elements and the Quality of Life in Post-menopausal Women After Radiotherapy
This study will be conducted on 28 participants who are survivors of breast cancer and underwent radiotherapy. The purpose of the current study is to investigate the effect of aerobic exercises on quality of life and serum levels of Zinc, Copper and iron in post-menopausal women who received radiotherapy after surviving breast cancer.
Read the detailed description
Breast cancer (BC) is the most common type of cancer in women globally. Several studies observed changes in the serum blood levels of trace elements in BC. Essential trace elements have relevant functions in a large number of cellular processes, with multiple roles in the correct functioning of metabolic enzymes.
There were previous trials to investigate the effect of exercise on trace elements in different populations as in the elite sportsmen. Some other studies to investigate the effect of exercise on breast cancer survivors for instance stated that physical exercise has effects on psychosocial functioning and health-related quality of life in breast cancer patients and survivors. Also, stated that aerobic exercise is the possible easiest solution to improve quality of life. Lastly, proved that exercise during adjuvant radiotherapy for breast cancer has positive impact on reducing fatigue and improve quality of life . However, there are no previous studies to investigate the effect of exercise on trace elements in BC patients nor identifying the optimal dose or parameters of the exercise. So, this study is an attempt to add to the clinical knowledge in this field as it will be the first one that investigates the effect of aerobic exercise on trace elements in women survived BC.
- Being tested
- Aerobic Exercise three time a week
- Keywords
- trace elements, breast cancer, aerobic exercise
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Aerobic Exercise three time a weekOther
The participants will receive mild to moderate aerobic exercise for three weeks for 12 sessions.
| Study group | Role | What they receive |
|---|---|---|
| Aerobic exercise three times a week | Experimental | The participants will receive mild to moderate aerobic exercise for three weeks for 12 sessions. Receives: Other: Aerobic Exercise three time a week |
| No Exercise group | No intervention | This group will act as a control group. |
What is being measured
The primary outcome is the main question the study is designed to answer.
trace elements levels
Blood testing for Fe, Zn, and Cu elements
Measured: 2 months
Secondary outcomes (1)
Quality of life questionnaire (EORTC QLQ-C30)
Quality of life will be assessed using the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30). This instrument includes multiple scales: Global Health Status/Quality of Life, five functional scales (Physical, Role, Emotional, Cognitive, and Social functioning), and several symptom scales/items.
Each scale is transformed to a score ranging from 0 to 100.
For the Global Health Status/Quality of Life scale and functional scales, higher scores indicate a better level of functioning and quality of life.
For the symptom scales/items, higher scores indicate a greater level of symptoms or problems (worse outcome).
Measured: 2 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Oct 2023
- Study start10 Oct 2023
- Primary completion13 Sep 2025
- Study completion17 Jan 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Trace Elements Levels After Breast Cancer RadiotherapyStudies 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
- Aerobic exercises and no intervention
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 28 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Tarek Hussein Mostafa, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06070155
- Sponsor's protocol ID
- P.T.REC/012/004581
- Status last verified
- Mar 2026
- First submitted
- 30 Sep 2023
- Last updated
- 1 Apr 2026
- Results posted
- 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 1 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Aerobic Exercises on Some Trace Elements and the Quality of Life in Post-menopausal Women After Radiotherapy
- ClinicalTrials.gov ID
- NCT06070155
- Acronym / sponsor ID
- P.T.REC/012/004581
- Keywords
- trace elements, breast cancer, aerobic exercise
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 28 participants (actual)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 10 Oct 2023 (actual)
- Primary completion
- 13 Sep 2025 (actual)
- Study completion
- 17 Jan 2026 (actual)
- First posted
- 6 Oct 2023 (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.
This study will be conducted on 28 participants who are survivors of breast cancer and underwent radiotherapy. The purpose of the current study is to investigate the effect of aerobic exercises on quality of life and serum levels of Zinc, Copper and iron in post-menopausal women who received radiotherapy after surviving breast cancer.
Detailed description
Breast cancer (BC) is the most common type of cancer in women globally. Several studies observed changes in the serum blood levels of trace elements in BC. Essential trace elements have relevant functions in a large number of cellular processes, with multiple roles in the correct functioning of metabolic enzymes.
There were previous trials to investigate the effect of exercise on trace elements in different populations as in the elite sportsmen. Some other studies to investigate the effect of exercise on breast cancer survivors for instance stated that physical exercise has effects on psychosocial functioning and health-related quality of life in breast cancer patients and survivors. Also, stated that aerobic exercise is the possible easiest solution to improve quality of life. Lastly, proved that exercise during adjuvant radiotherapy for breast cancer has positive impact on reducing fatigue and improve quality of life . However, there are no previous studies to investigate the effect of exercise on trace elements in BC patients nor identifying the optimal dose or parameters of the exercise. So, this study is an attempt to add to the clinical knowledge in this field as it will be the first one that investigates the effect of aerobic exercise on trace elements in women survived BC.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
- Model description
- Aerobic exercises and no intervention
| Arm | Type | Receives |
|---|---|---|
| Aerobic exercise three times a week | Experimental | Other: Aerobic Exercise three time a weekThe participants will receive mild to moderate aerobic exercise for three weeks for 12 sessions. |
| No Exercise group | No intervention | –This group will act as a control group. |
Who may qualify
- Ages
- 50 to 60 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- All postmenopausal women with breast cancer and received radiotherapy immediately at the end of radiotherapy or max six months to one year in each group. after clinically diagnosed by Oncologist with breast cancer Stage I and II .
- Their ages will range from 50-60 years old.
- Good general Health (ECOG performance status 0-1).
- Voluntary acceptance of participation in the study.
Key exclusion criteria (3 listed)
- Systematic chronic diseases (respiratory diseases, cardiovascular diseases…etc)
- Cognitive dysfunction as well as neuromuscular or musculoskeletal impairment or disease affecting postural control or motion pattern.
- Professional athletes.
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 Exercise three time a weekThe participants will receive mild to moderate aerobic exercise for three weeks for 12 sessions. | Other | Aerobic exercise three times a week |
Primary outcome
trace elements levels
Time frame: 2 months
Blood testing for Fe, Zn, and Cu elements
1 secondary outcome
Quality of life questionnaire (EORTC QLQ-C30)
Time frame: 2 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Apr 2026.
- Individual participant dataSharing planned: No
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.
The record lists no contact. Use the official record to reach the sponsor.
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 Exercise three time a week in people with Trace Elements Levels After Breast Cancer Radiotherapy, 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 4 inclusion and 3 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: finished, as of the sponsor's last update on 1 Apr 2026. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
trace elements levels (time frame: 2 months). 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 1 Apr 2026.