Effect of Aerobic Exercises on Trace Elements in Post-menopausal Women After Radiotherapy

NCT ID: NCT06070155

Last Updated: 2023-10-06

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

28 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-10-31

Study Completion Date

2024-01-31

Brief Summary

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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

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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.

Conditions

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Trace Elements Levels After Breast Cancer Radiotherapy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Aerobic exercises and no intervention
Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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Aerobic exercise three times a week

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

Group Type EXPERIMENTAL

Aerobic Exercise three time a week

Intervention Type OTHER

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

No Exercise group

This group will act as a control group.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Aerobic Exercise three time a week

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

Intervention Type OTHER

Eligibility Criteria

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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.
Minimum Eligible Age

50 Years

Maximum Eligible Age

60 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Cairo University

OTHER

Sponsor Role lead

Responsible Party

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Tarek Hussein Mostafa

Principal investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Tarek Hussein

Cairo, Cairo Governorate, Egypt

Site Status RECRUITING

Countries

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Egypt

Central Contacts

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Tarek Hussein

Role: CONTACT

01005729988

Facility Contacts

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Tarek Hussein

Role: primary

01005729988

Other Identifiers

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P.T.REC/012/004581

Identifier Type: -

Identifier Source: org_study_id

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