Effect of Aerobic Exercises on Trace Elements in Post-menopausal Women After Radiotherapy
Effect of Aerobic Exercises on Some Trace Elements and the Quality of Life in Post-menopausal Women After Radiotherapy
Study Overview
Status
Intervention / Treatment
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 Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Cairo Governorate
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Cairo, Cairo Governorate, Egypt, 11931
- Tarek Hussein
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Aerobic exercise three times a week
The participants will receive mild to moderate aerobic exercise for three weeks for 12 sessions.
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The participants will receive mild to moderate aerobic exercise for three weeks for 12 sessions.
|
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No Intervention: No Exercise group
This group will act as a control group.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
trace elements levels
Time Frame: 2 months
|
Blood testing for Fe, Zn, and Cu elements
|
2 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Quality of life questionnaire (EORTC QLQ-C30)
Time Frame: 2 months
|
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). |
2 months
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- P.T.REC/012/004581
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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