Clinical trial NCT06070155: Effect of Aerobic Exercises on Trace Elements in Post-menopausal Women After Radiotherapy
Official title: Effect of Aerobic Exercises on Some Trace Elements and the Quality of Life in Post-menopausal Women After Radiotherapy
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Trace Elements Levels After Breast Cancer Radiotherapy
Keywords: trace elements
breast cancer
aerobic exercise
Lead sponsor: Cairo University
Sponsor class: OTHER
First posted: 2023-10-06
Enrollment: 28
Sex: FEMALE
Minimum age (years): 50
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Aerobic exercises and no intervention
Primary purpose: TREATMENT

Brief 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.

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.

Primary outcomes:
measure: trace elements levels
timeFrame: 2 months
Secondary outcomes:
measure: EORTC QLQ-C30
timeFrame: 2 months
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Tarek Hussein
state: Cairo Governorate
Study officials:
References: