Breast Cancer SurvivorNCT06859593
Upper Extremity Exercise Capacity Of Breast Cancer
An observational study of Breast Cancer Survivor and Healty Controls, run by Hacettepe University at 1 site in Turkey (Türkiye).
Trial summary
Breast cancer is one of the most common cancers among women worldwide, with an incidence rate of up to 16%. Although survival can be improved with early diagnosis and more effective therapies, physical complications such as lymphedema, upper extremity dysfunction and chronic pain are common during and/or after breast… Read more about this study
- Who is it for?
- Ages 18 to 65 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Breast Cancer Survivor, Healty Controls
- What is being tested?
- Upper Extremity Exercise Capacity, 6-Minute Pegboard And Ring Test
- How many people
- 48 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Mar 2025to 1 Jun 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Study population: Patients between the ages of 18-65 years who are diagnosed with breast cancer at Hacettepe University Hospital, Department of Internal Medicine, Division of Medical Oncology, and who volunteer to participate in the study will be included in the study. For healthy groups, age and gender appropriate volunteers will be recruited for the study
Who may be able to join
- Breast Cancer Group:
- Being between 18-65 years of age,
- Volunteering to participate in the research,
- Stage I-III breast cancer,
- At least 15 months after breast cancer surgery,
- Six months after active breast cancer treatment (i.e. surgery/chemotherapy),
Show all 11Show fewer
- No problems in reading and/or understanding the scales and being able to cooperate with the tests,
- Healthy group:
- Age between 18-65 years,
- Volunteering to participate in the research,
- No problems in reading and/or understanding the scales and being able to cooperate with the tests.
Who cannot join
- Breast Cancer Group:
- Presence of active infection,
- Musculoskeletal and neurological diseases that may affect exercise performance, symptomatic heart disease,
- Having a neurological disease or other clinical diagnosis that may affect cognitive status.
- Healthy group:
- Having any orthopedic or neuromuscular condition that would interfere with walking or exercise performance,
- Having any chronic disease or psychiatric disorders or mental impairments that may interfere with cooperation or compliance with exercise tests
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Hcettepe University, Ankara, State 06100
Ankara, State, 06100
About this study
Official title: Comparison Of Upper Extremity Exercise Capacity Of Breast Cancer Patients With Healthy Individuals
Breast cancer is one of the most common cancers among women worldwide, with an incidence rate of up to 16%. Although survival can be improved with early diagnosis and more effective therapies, physical complications such as lymphedema, upper extremity dysfunction and chronic pain are common during and/or after breast cancer treatments. In addition, lymphedema can cause symptoms such as decreased muscle strength and range of motion of the upper extremity, pain and fatigue, resulting in activity limitations and decreased functional level of the upper extremity.
Read the detailed description
Breast cancer is one of the most common cancers among women worldwide, with an incidence rate of up to 16%. While the breast cancer survival rate is 80% in developed countries, this rate varies between 40-60% in low-middle income countries. Although survival can be increased with early diagnosis and more effective therapies, physical complications such as lymphedema, upper extremity dysfunction and chronic pain are frequently observed during and/or after breast cancer treatments. Upper extremity lymphedema that develops after breast cancer treatment usually affects the glenohumeral joint by increasing the tension in the tendons of the rotator cuff muscles and disrupting the scapulohumeral rhythm. In addition, lymphedema may cause symptoms such as decreased muscle strength and range of motion of the upper extremity, pain and fatigue, resulting in activity limitations and decreased functional level of the upper extremity. Kinesiophobia (fear-avoidance reaction to activity), which may develop in patients in relation to the affected extremity, is another factor in decreased capacity of the upper extremity. Patients may restrict the use of their extremities to prevent aggravation of lymphedema. Decreased functional capacity is common after breast cancer treatment. The '6 Minute Pegboard and Ring Test-6PBRT' is a valid and reliable, useful, practical and easy-to-administer test that evaluates unsupported arm endurance in breast cancer patients, patients with COPD, patients with asthma and healthy individuals. For the test, patients are asked to carry as many rings as possible within 6 minutes and the number of rings carried for 6 minutes is recorded as a score. In a study conducted in patients with mild to very severe COPD, it was shown that there was a positive correlation between the 6PBRT score and activity counts assessed by accelerometry. In addition, the 6PBRT score showed a clear relationship with upper extremity ROM and it was concluded that the 6PBRT test can be used as a suitable test for predicting and demonstrating improvement of ROM in pulmonary rehabilitation programs. Therefore, the aim of this study was to test both arm endurance and arm exercise capacity of patients with breast cancer using the 6PBRT test and to compare them with healthy individuals to understand how much they are affected compared to healthy individuals.
As a secondary aim of the study, it is planned to investigate the relationship between lymph edema severity and anthropometric measurements and upper extremity activities and arm exercise capacity in the group with breast cancer.
- Conditions
- Breast Cancer Survivor, Healty Controls
- Being tested
- Upper Extremity Exercise Capacity, 6-Minute Pegboard And Ring Test
- Keywords
- breast cancer, upper extremity, 6-minute pegboard and ring test, exercise capacity
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Upper Extremity Exercise Capacity, 6-Minute Pegboard And Ring TestDiagnostic test
Upper Extremity Exercise Capacity
| Study group | Role | What they receive |
|---|---|---|
| Breast Cancer Group | Inclusion criteria were to be between 18-65 years of age, to volunteer to participate in the study, to have Stage I-III breast cancer, to have at least 15 months after breast cancer surgery, to have six months after active breast cancer treatment (i.e. surgery/chemotherapy), to have no problems in reading and/or understanding the scales and to be able to cooperate with the tests. Exclusion criteria were the presence of active infection, musculoskeletal and neurologic disease that may affect exercise performance, symptomatic heart disease, neurologic disease or other clinical diagnosis that may affect cognitive status. Receives: Diagnostic Test: Upper Extremity Exercise Capacity, 6-Minute Pegboard And Ring Test | |
| Control Group | The inclusion criteria were to be between 18-65 years of age, to be willing to participate in the study, to have no problems in reading and/or understanding the scales and to be able to cooperate with the tests. Exclusion criteria were having any orthopedic or neuromuscular condition that would interfere with walking or exercise performance, having any chronic disease, or having psychiatric disorders or mental disorders that might interfere with cooperation or compliance with exercise tests. Receives: Diagnostic Test: Upper Extremity Exercise Capacity, 6-Minute Pegboard And Ring Test |
What is being measured
The primary outcome is the main question the study is designed to answer.
Upper Extremity Exercise Capacity
6-Minute Pegboard and Ring Test
Measured: One Year
Secondary outcomes (3)
Evaluation of Upper Extremity Functionality
Questionnaire Quick Disability of the Arm, Shoulder, and Hand (Quick DASH) The score ranges from 0 to 100. A higher score reflects more severe upper extremity dysfunction, and the cutoff scores are 0-15 for normal, 16-40 for having problems but working, and more than 40 for being unable to work
Measured: One Year
Lymphedema Evaluation
Arm circumference measurement
Measured: One Year
Measurement of arm length, arm and forearm circumference
The circumference and length measurements of the participants' dominant and non-dominant arm will be measured using a tape measure
Measured: One Year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Mar 2025
- Study start1 Mar 2025
- Primary completion1 May 2025
- Study completion1 Jun 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast Cancer SurvivorStudies of the same condition, open and under way.
- More trials run by Hacettepe UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Cross-sectional
- Enrolment
- 48 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hacettepe University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ebru Calik Kutukcu, Hacettepe University
- Investigators
- Melda Saglam, PhD, Study chair, Hacettepe University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06859593
- Sponsor's protocol ID
- FTREK 25/01
- Status last verified
- Jul 2025
- First submitted
- 28 Feb 2025
- Last updated
- 9 Jul 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison Of Upper Extremity Exercise Capacity Of Breast Cancer Patients With Healthy Individuals
- ClinicalTrials.gov ID
- NCT06859593
- Acronym / sponsor ID
- FTREK 25/01
- Conditions
- Breast Cancer Survivor, Healty Controls
- Keywords
- breast cancer, upper extremity, 6-minute pegboard and ring test, exercise capacity
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 48 participants (actual)
- Lead sponsor
- Hacettepe UniversityUniversity, hospital or other
- Study start
- 1 Mar 2025 (actual)
- Primary completion
- 1 May 2025 (actual)
- Study completion
- 1 Jun 2025 (actual)
- First posted
- 5 Mar 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Breast cancer is one of the most common cancers among women worldwide, with an incidence rate of up to 16%. Although survival can be improved with early diagnosis and more effective therapies, physical complications such as lymphedema, upper extremity dysfunction and chronic pain are common during and/or after breast cancer treatments. In addition, lymphedema can cause symptoms such as decreased muscle strength and range of motion of the upper extremity, pain and fatigue, resulting in activity limitations and decreased functional level of the upper extremity.
Detailed description
Breast cancer is one of the most common cancers among women worldwide, with an incidence rate of up to 16%. While the breast cancer survival rate is 80% in developed countries, this rate varies between 40-60% in low-middle income countries. Although survival can be increased with early diagnosis and more effective therapies, physical complications such as lymphedema, upper extremity dysfunction and chronic pain are frequently observed during and/or after breast cancer treatments. Upper extremity lymphedema that develops after breast cancer treatment usually affects the glenohumeral joint by increasing the tension in the tendons of the rotator cuff muscles and disrupting the scapulohumeral rhythm. In addition, lymphedema may cause symptoms such as decreased muscle strength and range of motion of the upper extremity, pain and fatigue, resulting in activity limitations and decreased functional level of the upper extremity. Kinesiophobia (fear-avoidance reaction to activity), which may develop in patients in relation to the affected extremity, is another factor in decreased capacity of the upper extremity. Patients may restrict the use of their extremities to prevent aggravation of lymphedema. Decreased functional capacity is common after breast cancer treatment. The '6 Minute Pegboard and Ring Test-6PBRT' is a valid and reliable, useful, practical and easy-to-administer test that evaluates unsupported arm endurance in breast cancer patients, patients with COPD, patients with asthma and healthy individuals. For the test, patients are asked to carry as many rings as possible within 6 minutes and the number of rings carried for 6 minutes is recorded as a score. In a study conducted in patients with mild to very severe COPD, it was shown that there was a positive correlation between the 6PBRT score and activity counts assessed by accelerometry. In addition, the 6PBRT score showed a clear relationship with upper extremity ROM and it was concluded that the 6PBRT test can be used as a suitable test for predicting and demonstrating improvement of ROM in pulmonary rehabilitation programs. Therefore, the aim of this study was to test both arm endurance and arm exercise capacity of patients with breast cancer using the 6PBRT test and to compare them with healthy individuals to understand how much they are affected compared to healthy individuals.
As a secondary aim of the study, it is planned to investigate the relationship between lymph edema severity and anthropometric measurements and upper extremity activities and arm exercise capacity in the group with breast cancer.
Study design
- Observational model
- Other
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Breast Cancer Group | – | Diagnostic Test: Upper Extremity Exercise Capacity, 6-Minute Pegboard And Ring TestInclusion criteria were to be between 18-65 years of age, to volunteer to participate in the study, to have Stage I-III breast cancer, to have at least 15 months after breast cancer surgery, to have six months after active breast cancer treatment (i.e. surgery/chemotherapy), to have no problems in reading and/or understanding the scales and to be able to cooperate with the tests. Exclusion criteria were the presence of active infection, musculoskeletal and neurologic disease that may affect exercise performance, symptomatic heart disease, neurologic disease or other clinical diagnosis that may affect cognitive status. |
| Control Group | – | Diagnostic Test: Upper Extremity Exercise Capacity, 6-Minute Pegboard And Ring TestThe inclusion criteria were to be between 18-65 years of age, to be willing to participate in the study, to have no problems in reading and/or understanding the scales and to be able to cooperate with the tests. Exclusion criteria were having any orthopedic or neuromuscular condition that would interfere with walking or exercise performance, having any chronic disease, or having psychiatric disorders or mental disorders that might interfere with cooperation or compliance with exercise tests. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Patients between the ages of 18-65 years who are diagnosed with breast cancer at Hacettepe University Hospital, Department of Internal Medicine, Division of Medical Oncology, and who volunteer to participate in the study will be included in the study. For healthy groups, age and gender appropriate volunteers will be recruited for the study
Key inclusion criteria (11 listed)
- Being between 18-65 years of age,
- Volunteering to participate in the research,
- Stage I-III breast cancer,
- At least 15 months after breast cancer surgery,
- Six months after active breast cancer treatment (i.e. surgery/chemotherapy),
Key exclusion criteria (7 listed)
- Presence of active infection,
- Musculoskeletal and neurological diseases that may affect exercise performance, symptomatic heart disease,
- Having a neurological disease or other clinical diagnosis that may affect cognitive status.
- Having any orthopedic or neuromuscular condition that would interfere with walking or exercise performance,
- Having any chronic disease or psychiatric disorders or mental impairments that may interfere with cooperation or compliance with exercise tests
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Upper Extremity Exercise Capacity, 6-Minute Pegboard And Ring TestUpper Extremity Exercise Capacity | Diagnostic test | Breast Cancer Group, Control Group |
Primary outcome
Upper Extremity Exercise Capacity
Time frame: One Year
6-Minute Pegboard and Ring Test
3 secondary outcomes
Evaluation of Upper Extremity Functionality
Time frame: One Year
Lymphedema Evaluation
Time frame: One Year
Measurement of arm length, arm and forearm circumference
Time frame: One Year
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Jul 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Melda Saglam, PhD study chair
Hacettepe University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Breast Cancer Survivor and Healty Controls, run by Hacettepe University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 11 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 9 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Upper Extremity Exercise Capacity (time frame: One Year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Jul 2025.