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

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.

Study Overview

• Status: Completed
• Conditions: Trace Elements Levels After Breast Cancer Radiotherapy
• Intervention / Treatment: Other: Aerobic Exercise three time a week

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: Interventional
• Enrollment (Actual): 28
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Egypt
  • Cairo Governorate
    • Cairo, Cairo Governorate, Egypt, 11931
      • Tarek Hussein

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: No

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

Number of Arms

2

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.	Other: Aerobic Exercise three time a week; The participants will receive mild to moderate aerobic exercise for three weeks for 12 sessions.
No Intervention: No Exercise group; This group will act as a control group.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
trace elements levels	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)	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: Cairo University

Study record dates

Study Major Dates

• Study Start (Actual): October 10, 2023
• Primary Completion (Actual): September 13, 2025
• Study Completion (Actual): January 17, 2026

Study Registration Dates

• First Submitted: September 30, 2023
• First Submitted That Met QC Criteria: September 30, 2023
• First Posted (Actual): October 6, 2023

Study Record Updates

• Last Update Posted (Actual): April 1, 2026
• Last Update Submitted That Met QC Criteria: March 27, 2026
• Last Verified: March 1, 2026

More Information

Terms related to this study

• Keywords: breast cancer; aerobic exercise; trace elements
• Additional Relevant MeSH Terms: Neoplasms by Site; Neoplasms; Skin Diseases; Breast Diseases; Skin and Connective Tissue Diseases; Breast Neoplasms
• Other Study ID Numbers: P.T.REC/012/004581

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No