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NCT Number: NCT06070155

Effect of Aerobic Exercises on Trace Elements 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.

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Key information

Conditions

Trace Elements Levels After Breast Cancer Radiotherapy Breast Diseases Breast Neoplasms Neoplasms Neoplasms by Site Skin Diseases Skin and Connective Tissue Diseases

Age range

50 year–60 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Tarek Hussein

Cairo, Cairo Governorate, 11931, Egypt

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Aerobic Exercise three time a week

Other

The participants will receive mild to moderate aerobic exercise for three weeks for 12 sessions.

Primary outcomes

  1. trace elements levels

    Time frame: 2 months

    Blood testing for Fe, Zn, and Cu elements

Secondary outcomes

  1. 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).

Sponsors and collaborators

Lead sponsor

Cairo University

Other

Registry information

Official study title

Effect of Aerobic Exercises on Some Trace Elements and the Quality of Life in Post-menopausal Women After Radiotherapy

Important dates

Study start
2023
Primary completion
2025
Study completion
2026
First posted
Oct 6, 2023
Registry last updated
Apr 1, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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