Breast CancerNCT07876375
UPPER EXTREMITY FUNCTION AND LYMPHEDEMA IN BREAST CANCER SURVIVORS
An observational study of Breast Cancer and Breast Cancer Female, run by Pamukkale University at 1 site in Turkey (Türkiye).
Trial summary
In this study, the investigators investigated upper extremity function and breast cancer-related lymphedema in individuals following breast cancer surgery and treatments Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Breast Cancer, Breast Cancer Female
- How many people
- 175 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Jul 2025to 30 Apr 2026
- 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 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Study population: The study included 175 patients aged 18 and older who were being followed up at the Breast Clinic of the Department of General Surgery at Pamukkale University (following mastectomy and curative treatment) and who had undergone breast surgery.
Who may be able to join
- Be under follow-up at the PAU Breast Clinic, with stable symptoms and medication regimens
- Have undergone surgery following a diagnosis of breast cancer and an indication for breast surgery
- Have a level of cognitive function appropriate for the study's requirements and be able to understand what they read and respond accordingly
Who cannot join
- Not having undergone breast surgery
- Lack of cooperation
- Development of metastases
- Recurrence of the disease
- Bilateral breast cancer
- History of a second cancer
Trial locations and contacts
1 site in 1 country.
About this study
Official title: UPPER EXTREMITY FUNCTION AND LYMPHEDEMA IN BREAST CANCER SURVIVORS: A CROSS-SECTIONAL STUDY
In this study, the investigators investigated upper extremity function and breast cancer-related lymphedema in individuals following breast cancer surgery and treatments
Read the detailed description
Written informed consent was obtained from the participants; their demographic information and clinical characteristics (related to surgery and cancer treatment) were recorded; and shoulder pain, upper extremity functional status, and lymphedema were assessed. The Shoulder Pain and Disability Index was used to assess shoulder-related functional impairment and activities of daily living, and a hand dynamometer test was used to assess upper extremity muscle strength. For lymphedema, circumference measurements were used to calculate extremity volume using the Frustum formula, and subcutaneous fluid ratios were measured. Assessments were performed only once for each participant.
- Conditions
- Breast Cancer, Breast Cancer Female
- Keywords
- breast cancer survival, breast cancer releated lymphedema, upper extremity function, muscle strenght
- Medical subject headings
- Breast Neoplasms
What is being measured
The primary outcome is the main question the study is designed to answer.
upper extremity function- pain and disability
The Shoulder Pain and Disability Index was used to assess functional impairment of the shoulder and activities of daily living. The pain subparameter consists of 5 questions related to shoulder pain during daily living activities, and the activity limitation subparameter consists of 8 questions related to difficulty performing daily living activities. Responses are numerically scored by the participants on a scale of 0-10. To determine the value of each subparameter, the scores of all responses are summed and divided by the number of questions in that subparameter. The total score is determined as the average of the scores of the two subparameters. A higher score indicates increased pain and impaired shoulder function.
Measured: july 2025-april 2026
breast cancer-related lymphedema - volume
Circumference measurements were taken to assess upper extremity lymphedema, and volume was calculated using the frustum formula. The calculated volume difference between the two extremities of less than 200 ml does not rule out lymphedema, but a difference of ≥200 ml indicates lymphedema.
Measured: july 2025-april 2026
Secondary outcomes (2)
upper extremity function- muscle strenght
A handheld dynamometer test was used to assess upper extremity muscle strength. Three measurements were made and the average is recorded.
Measured: july 2025-april 2026
breast cancer-related lymphedema - tissue dielectric constant
Tissue dielectric constant was determined by measuring the subcutaneous fluid density of individuals at reference points using the Moisture Meter-D compact (MMDc, Delfin Technologies, Finland) device. Reference points are the midpoint 10 cm below the axilla, and 6 cm distal and 8 cm proximal to the antecubital line. Individuals were informed about the device and measurements before the procedure. Care was taken to ensure there are no creams or lotions on the skin. After individuals rest in a supine position for 10 minutes, 3 repeated measurements were taken at the reference points on both extremities, and the averages were recorded.
Measured: july 2025-april 2026
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Oct 2026
- Study start1 Jul 2025
- Primary completion30 Apr 2026
- Study completion30 Apr 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast CancerStudies of the same condition, open and under way.
- More trials run by Pamukkale 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
- 175 participants (actual)
Sponsor and investigators
- Lead sponsor
- Pamukkale University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, ATİYE KAŞ ÖZDEMİR, Pamukkale University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07876375
- Sponsor's protocol ID
- E-60116787-020-719072
- Status last verified
- Oct 2026
- First submitted
- 9 Oct 2026
- Last updated
- 21 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: The data of the study are available from the corresponding author upon reasonable request.
Study at a glance
From the registry record, last updated by the sponsor on 21 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- UPPER EXTREMITY FUNCTION AND LYMPHEDEMA IN BREAST CANCER SURVIVORS: A CROSS-SECTIONAL STUDY
- ClinicalTrials.gov ID
- NCT07876375
- Acronym / sponsor ID
- E-60116787-020-719072
- Conditions
- Breast Cancer, Breast Cancer Female
- Keywords
- breast cancer survival, breast cancer releated lymphedema, upper extremity function, muscle strenght
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 175 participants (actual)
- Lead sponsor
- Pamukkale UniversityUniversity, hospital or other
- Study start
- 1 Jul 2025 (actual)
- Primary completion
- 30 Apr 2026 (actual)
- Study completion
- 30 Apr 2026 (actual)
- First posted
- 15 Oct 2026 (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.
In this study, the investigators investigated upper extremity function and breast cancer-related lymphedema in individuals following breast cancer surgery and treatments
Detailed description
Written informed consent was obtained from the participants; their demographic information and clinical characteristics (related to surgery and cancer treatment) were recorded; and shoulder pain, upper extremity functional status, and lymphedema were assessed. The Shoulder Pain and Disability Index was used to assess shoulder-related functional impairment and activities of daily living, and a hand dynamometer test was used to assess upper extremity muscle strength. For lymphedema, circumference measurements were used to calculate extremity volume using the Frustum formula, and subcutaneous fluid ratios were measured. Assessments were performed only once for each participant.
Study design
- Observational model
- Other
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The study included 175 patients aged 18 and older who were being followed up at the Breast Clinic of the Department of General Surgery at Pamukkale University (following mastectomy and curative treatment) and who had undergone breast surgery.
Key inclusion criteria (3 listed)
- Be under follow-up at the PAU Breast Clinic, with stable symptoms and medication regimens
- Have undergone surgery following a diagnosis of breast cancer and an indication for breast surgery
- Have a level of cognitive function appropriate for the study's requirements and be able to understand what they read and respond accordingly
Key exclusion criteria (6 listed)
- Not having undergone breast surgery
- Lack of cooperation
- Development of metastases
- Recurrence of the disease
- Bilateral breast cancer
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
upper extremity function- pain and disability
Time frame: july 2025-april 2026
The Shoulder Pain and Disability Index was used to assess functional impairment of the shoulder and activities of daily living. The pain subparameter consists of 5 questions related to shoulder pain during daily living activities, and the activity limitation subparameter consists of 8 questions related to difficulty performing daily living activities. Responses are numerically scored by the participants on a scale of 0-10. To determine the value of each subparameter, the scores of all responses are summed and divided by the number of questions in that subparameter. The total score is determined as the average of the scores of the two subparameters. A higher score indicates increased pain and impaired shoulder function.
breast cancer-related lymphedema - volume
Time frame: july 2025-april 2026
Circumference measurements were taken to assess upper extremity lymphedema, and volume was calculated using the frustum formula. The calculated volume difference between the two extremities of less than 200 ml does not rule out lymphedema, but a difference of ≥200 ml indicates lymphedema.
2 secondary outcomes
upper extremity function- muscle strenght
Time frame: july 2025-april 2026
breast cancer-related lymphedema - tissue dielectric constant
Time frame: july 2025-april 2026
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 21 Oct 2026.
- Individual participant dataSharing planned: Undecided. The data of the study are available from the corresponding author upon reasonable request.
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 and Breast Cancer Female, run by Pamukkale 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 3 inclusion and 6 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 21 Oct 2026. 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 function- pain and disability (time frame: july 2025-april 2026). The study lists 2 primary outcomes in all. 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 21 Oct 2026.