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Trial Title:
Effect of Aerobic Exercises on Trace Elements in Post-menopausal Women After Radiotherapy
NCT ID:
NCT06070155
Condition:
Trace Elements Levels After Breast Cancer Radiotherapy
Conditions: Official terms:
Breast Neoplasms
Conditions: Keywords:
trace elements
breast cancer
aerobic exercise
Study type:
Interventional
Study phase:
N/A
Overall status:
Recruiting
Study design:
Allocation:
Randomized
Intervention model:
Parallel Assignment
Intervention model description:
Aerobic exercises and no intervention
Primary purpose:
Treatment
Masking:
Double (Participant, Investigator)
Intervention:
Intervention type:
Other
Intervention name:
Aerobic Exercise three time a week
Description:
The participants will receive mild to moderate aerobic exercise for three weeks for 12
sessions.
Arm group label:
Aerobic exercise three times a week
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 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 (Duijts et al., 2011) stated
that physical exercise has effects on psychosocial functioning and health-related quality
of life in breast cancer patients and survivors. Also, (Lambrigts et al., 2022) stated
that aerobic exercise is the possible easiest solution to improve quality of life.
Lastly, (Lipsett et al., 2017) 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.
Criteria for eligibility:
Criteria:
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.
Gender:
Female
Minimum age:
50 Years
Maximum age:
60 Years
Healthy volunteers:
No
Locations:
Facility:
Name:
Tarek Hussein
Address:
City:
Cairo
Zip:
11931
Country:
Egypt
Status:
Recruiting
Contact:
Last name:
Tarek Hussein
Phone:
01005729988
Email:
dr_tareq92@yahoo.com
Start date:
October 2023
Completion date:
January 2024
Lead sponsor:
Agency:
Cairo University
Agency class:
Other
Source:
Cairo University
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06070155
