search
Back to results

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

Primary Purpose

Trace Elements Levels After Breast Cancer Radiotherapy

Status
Recruiting
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
Aerobic Exercise three time a week
Sponsored by
Cairo University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Trace Elements Levels After Breast Cancer Radiotherapy focused on measuring trace elements, breast cancer, aerobic exercise

Eligibility Criteria

50 Years - 60 Years (Adult)FemaleDoes not accept healthy volunteers

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.

Sites / Locations

  • Tarek HusseinRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Aerobic exercise three times a week

No Exercise group

Arm Description

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

This group will act as a control group.

Outcomes

Primary Outcome Measures

trace elements levels
blood testing

Secondary Outcome Measures

EORTC QLQ-C30
Quality of life questionnaire

Full Information

First Posted
September 30, 2023
Last Updated
September 30, 2023
Sponsor
Cairo University
search

1. Study Identification

Unique Protocol Identification Number
NCT06070155
Brief Title
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

2. Study Status

Record Verification Date
September 2023
Overall Recruitment Status
Recruiting
Study Start Date
October 2023 (Anticipated)
Primary Completion Date
December 2023 (Anticipated)
Study Completion Date
January 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Cairo University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Trace Elements Levels After Breast Cancer Radiotherapy
Keywords
trace elements, breast cancer, aerobic exercise

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Aerobic exercises and no intervention
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
28 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Aerobic exercise three times a week
Arm Type
Experimental
Arm Description
The participants will receive mild to moderate aerobic exercise for three weeks for 12 sessions.
Arm Title
No Exercise group
Arm Type
No Intervention
Arm Description
This group will act as a control group.
Intervention Type
Other
Intervention Name(s)
Aerobic Exercise three time a week
Intervention Description
The participants will receive mild to moderate aerobic exercise for three weeks for 12 sessions.
Primary Outcome Measure Information:
Title
trace elements levels
Description
blood testing
Time Frame
2 months
Secondary Outcome Measure Information:
Title
EORTC QLQ-C30
Description
Quality of life questionnaire
Time Frame
2 months

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
50 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Tarek Hussein
Phone
01005729988
Email
tarekhussein1992@gmail.com
Facility Information:
Facility Name
Tarek Hussein
City
Cairo
State/Province
Cairo Governorate
ZIP/Postal Code
11931
Country
Egypt
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Tarek Hussein
Phone
01005729988
Email
dr_tareq92@yahoo.com

12. IPD Sharing Statement

Plan to Share IPD
Undecided

Learn more about this trial

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

We'll reach out to this number within 24 hrs