Breast Cancer SurvivorsNCT07818811
Muscle Oxygenation and Function in Breast Cancer Survivors
An observational study of Breast Cancer Survivors, run by Pamukkale University.
Trial summary
Persistent impairments in upper extremity function are well documented among breast cancer survivors even after completion of cancer treatment. These impairments are frequently attributed to fatigue and other treatment-related complications. Read more about this study
- Who is it for?
- Ages 18 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Breast Cancer Survivors
- How many people
- 80 participants
- Where
- No sites listed yet
- Study dates
- Oct 2026to Nov 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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
- Healthy volunteers accepted
- Adult, Older adult
Study population: breast cancer survivors: At least 40 cases of patients aged 18 and older who met the inclusion criteria, who had undergone breast surgery (at least 6 months to a maximum of 15 years had elapsed since mastectomy and curative treatment), and who were being followed up at the General Surgery Breast Clinic of Pamukkale University healty individuals: At least 40 healthy individuals who are undergoing routine follow-up at the General Surgery Breast Clinic of Pamukkale University, have no history of cancer, and meet the criteria for inclusion in the control group
Who may be able to join
- Individuals diagnosed with stage 1, 2, or 3 unilateral breast cancer
- who completed breast cancer treatment at least 6 months ago
- whose clinical condition is stable
Who cannot join
- having an upper extremity disability or musculoskeletal disorder that could affect physical performance
- having undergone bilateral breast surgery
- development of recurrence or metastasis
- uncontrolled chronic cardiopulmonary diseases (hypertension, heart failure, peripheral artery disease, COPD, asthma, etc.), uncontrolled chronic conditions such as diabetes or neuromotor disorders, anemia, smoking, or cognitive impairment
- having participated in a regular exercise program within the last 6 months
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Upper Extremity Muscle Oxygenation Dynamics and Functional Performance in Breast Cancer Survivors
Persistent impairments in upper extremity function are well documented among breast cancer survivors even after completion of cancer treatment. These impairments are frequently attributed to fatigue and other treatment-related complications. Upper extremity function in patients undergoing breast cancer surgery may be affected by multiple factors, including surgical tissue trauma, axillary lymph node dissection or sentinel lymph node biopsy, radiation-induced fibrosis, pain, restricted shoulder range of motion, loss of muscle strength, and lymphedema. Muscle oxygenation may also be impaired through various mechanisms following breast cancer surgery and is considered one of the important microvascular mechanisms potentially underlying upper extremity functional impairments. However, muscle oxygenation has not been sufficiently investigated in this population. Existing studies have predominantly focused on lower extremity muscles, whereas changes in upper extremity muscle oxygenation have yet to be adequately investigated. This gap in the literature may limit the development and targeted implementation of appropriate exercise interventions and the identification of optimal exercise modalities aimed at improving upper extremity function in daily life, enhancing independence, facilitating participation in social and occupational activities, and ultimately improving quality of life among breast cancer survivors.
In this project, the investigators aim to investigate the relationship between tissue-level muscle oxygenation parameters and clinical measures of upper extremity function, including muscle strength, upper extremity functional capacity, and the score on the Disabilities of the Arm, Shoulder and Hand Questionnaire-Quick Version (QuickDASH). By examining these associations, the investigators intend to contribute to a better understanding of the pathophysiological mechanisms underlying functional impairments in breast cancer survivors and to provide a basis for the development of more effective and targeted rehabilitation protocols, including interventions designed to enhance microcirculation and aerobic exercise capacity.
Read more
Breast cancer survivors followed at the Breast Clinic of the Department of General Surgery at Pamukkale University and healthy individuals will be included in two study groups. Upper extremity muscle oxygenation and functional performance will be assessed using a hand-held dynamometer, near-infrared spectroscopy (NIRS), the six-minute pegboard and ring test, and the Disabilities of the Arm, Shoulder and Hand Questionnaire-Quick Version (QuickDASH).
By comparing upper extremity muscle oxygenation and functional performance between breast cancer survivors and healthy individuals, the findings of this project are expected to provide a better understanding of the muscle characteristics underlying upper extremity functional impairments in breast cancer survivors. These findings may contribute to the development and refinement of exercise interventions within rehabilitation programs and highlight the importance of selecting appropriate exercise modalities to improve upper extremity function in this population.
- Conditions
- Breast Cancer Survivors
- Keywords
- breast cancer survivors, muscle oxygenation, Upper extremity function, upper limb in breast cancer survivors, near-infrared spectroscopy, functional performance
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Breast cancer survivors | At least 40 cases of patients aged 18 and older who met the inclusion criteria, who had undergone breast surgery (at least 6 months to a maximum of 15 years had passed since mastectomy and curative treatment), and who were being followed up at the General Surgery Breast Clinic of Pamukkale University | |
| Healthy individuals | At least 40 healthy individuals who are undergoing routine follow-up at the General Surgery Breast Clinic of Pamukkale University, have no history of cancer, and meet the criteria for inclusion in the control group |
What is being measured
The primary outcome is the main question the study is designed to answer.
Muscle oxygenation will be assessed a noninvasive technique, using near-infrared spectroscopy (NIRS). NIRS can measure local muscle oxygen saturation (SmO₂) in the capillary bed of the underlying muscle tissue.
The NIRS sensor will be secured using a fiber-elastic band over the midline of the lateral deltoid muscle, immediately inferior to the acromion. Physiological variables, including the minimum, maximum, and change values of muscle oxygen saturation, will be recorded at rest and during and after the Six-Minute Pegboard and Ring Test. Muscle oxygenation will be expressed as the percentage of oxyhemoglobin relative to the sum of oxyhemoglobin and deoxyhemoglobin. Bilateral musce oxygenation of the middle portion of the deltoid muscle will be assessed before, during, and after the test. During exercise, an inability to adequately meet the increased oxygen demand of the working muscle may result in reduced SmO₂ levels. SmO₂ is influenced by shifts in the hemoglobin dissociation curve as well as by other chemical and neural factors.
Measured: october 2026 to august 2027
Secondary outcomes (1)
upper extremity muscle strength
The strength of the middle and anterior portions of the deltoid muscle will be assessed using a hand-held dynamometer. The test will be performed with the participant in an unsupported sitting position, with the shoulder positioned at 90° of abduction and 90° of flexion, in neutral rotation, and with the elbow fully extended. Resistance will be applied using the dynamometer over the distal humerus, and the participant will be instructed to attempt to elevate the arm with maximal force. Three measurements will be obtained, and the highest value will be recorded in Newtons (N).
Measured: october 2026 to august 2027
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Sep 2026
- Study startOct 2026 (estimated)
- Primary completionAug 2027 (estimated)
- Study completionNov 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast Cancer SurvivorsStudies 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
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Pamukkale University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, ATİYE KAŞ ÖZDEMİR, Pamukkale University
- Investigators
- Atiye KAŞ ÖZDEMİR, Lecturer, PhD., Principal investigator, Pamukkale UniversitySevda YILMAZ, Assoc. Prof. Dr., Study chair, Pamukkale UniversityOrçin TELLİ ATALAY, Prof. Dr., Study chair, Pamukkale University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07818811
- Sponsor's protocol ID
- 2026TAP034
- Other IDs
- 2026TAP034
- Status last verified
- Aug 2026
- First submitted
- 30 Aug 2026
- Last updated
- 14 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: There are currently no plans to share individual participant data with other researchers. Study results will be reported only in aggregated form, and no personally identifiable information will be disclosed.
Study at a glance
From the registry record, last updated by the sponsor on 14 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Upper Extremity Muscle Oxygenation Dynamics and Functional Performance in Breast Cancer Survivors
- ClinicalTrials.gov ID
- NCT07818811
- Acronym / sponsor ID
- 2026TAP034
- Conditions
- Breast Cancer Survivors
- Keywords
- breast cancer survivors, muscle oxygenation, Upper extremity function, upper limb in breast cancer survivors, near-infrared spectroscopy, functional performance
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Pamukkale UniversityUniversity, hospital or other
- Study start
- Oct 2026 (estimated)
- Primary completion
- Aug 2027 (estimated)
- Study completion
- Nov 2027 (estimated)
- First posted
- 14 Sep 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.
Persistent impairments in upper extremity function are well documented among breast cancer survivors even after completion of cancer treatment. These impairments are frequently attributed to fatigue and other treatment-related complications. Upper extremity function in patients undergoing breast cancer surgery may be affected by multiple factors, including surgical tissue trauma, axillary lymph node dissection or sentinel lymph node biopsy, radiation-induced fibrosis, pain, restricted shoulder range of motion, loss of muscle strength, and lymphedema. Muscle oxygenation may also be impaired through various mechanisms following breast cancer surgery and is considered one of the important microvascular mechanisms potentially underlying upper extremity functional impairments. However, muscle oxygenation has not been sufficiently investigated in this population. Existing studies have predominantly focused on lower extremity muscles, whereas changes in upper extremity muscle oxygenation have yet to be adequately investigated. This gap in the literature may limit the development and targeted implementation of appropriate exercise interventions and the identification of optimal exercise modalities aimed at improving upper extremity function in daily life, enhancing independence, facilitating participation in social and occupational activities, and ultimately improving quality of life among breast cancer survivors.
In this project, the investigators aim to investigate the relationship between tissue-level muscle oxygenation parameters and clinical measures of upper extremity function, including muscle strength, upper extremity functional capacity, and the score on the Disabilities of the Arm, Shoulder and Hand Questionnaire-Quick Version (QuickDASH). By examining these associations, the investigators intend to contribute to a better understanding of the pathophysiological mechanisms underlying functional impairments in breast cancer survivors and to provide a basis for the development of more effective and targeted rehabilitation protocols, including interventions designed to enhance microcirculation and aerobic exercise capacity.
Breast cancer survivors followed at the Breast Clinic of the Department of General Surgery at Pamukkale University and healthy individuals will be included in two study groups. Upper extremity muscle oxygenation and functional performance will be assessed using a hand-held dynamometer, near-infrared spectroscopy (NIRS), the six-minute pegboard and ring test, and the Disabilities of the Arm, Shoulder and Hand Questionnaire-Quick Version (QuickDASH).
By comparing upper extremity muscle oxygenation and functional performance between breast cancer survivors and healthy individuals, the findings of this project are expected to provide a better understanding of the muscle characteristics underlying upper extremity functional impairments in breast cancer survivors. These findings may contribute to the development and refinement of exercise interventions within rehabilitation programs and highlight the importance of selecting appropriate exercise modalities to improve upper extremity function in this population.
Study design
- Observational model
- Other
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Breast cancer survivors | – | –At least 40 cases of patients aged 18 and older who met the inclusion criteria, who had undergone breast surgery (at least 6 months to a maximum of 15 years had passed since mastectomy and curative treatment), and who were being followed up at the General Surgery Breast Clinic of Pamukkale University |
| Healthy individuals | – | –At least 40 healthy individuals who are undergoing routine follow-up at the General Surgery Breast Clinic of Pamukkale University, have no history of cancer, and meet the criteria for inclusion in the control group |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- breast cancer survivors: At least 40 cases of patients aged 18 and older who met the inclusion criteria, who had undergone breast surgery (at least 6 months to a maximum of 15 years had elapsed since mastectomy and curative treatment), and who were being followed up at the General Surgery Breast Clinic of Pamukkale University healty individuals: At least 40 healthy individuals who are undergoing routine follow-up at the General Surgery Breast Clinic of Pamukkale University, have no history of cancer, and meet the criteria for inclusion in the control group
Key inclusion criteria (3 listed)
- Individuals diagnosed with stage 1, 2, or 3 unilateral breast cancer
- who completed breast cancer treatment at least 6 months ago
- whose clinical condition is stable
Key exclusion criteria (5 listed)
- having an upper extremity disability or musculoskeletal disorder that could affect physical performance
- having undergone bilateral breast surgery
- development of recurrence or metastasis
- uncontrolled chronic cardiopulmonary diseases (hypertension, heart failure, peripheral artery disease, COPD, asthma, etc.), uncontrolled chronic conditions such as diabetes or neuromotor disorders, anemia, smoking, or cognitive impairment
- having participated in a regular exercise program within the last 6 months
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
Muscle oxygenation will be assessed a noninvasive technique, using near-infrared spectroscopy (NIRS). NIRS can measure local muscle oxygen saturation (SmO₂) in the capillary bed of the underlying muscle tissue.
Time frame: october 2026 to august 2027
The NIRS sensor will be secured using a fiber-elastic band over the midline of the lateral deltoid muscle, immediately inferior to the acromion. Physiological variables, including the minimum, maximum, and change values of muscle oxygen saturation, will be recorded at rest and during and after the Six-Minute Pegboard and Ring Test. Muscle oxygenation will be expressed as the percentage of oxyhemoglobin relative to the sum of oxyhemoglobin and deoxyhemoglobin. Bilateral musce oxygenation of the middle portion of the deltoid muscle will be assessed before, during, and after the test. During exercise, an inability to adequately meet the increased oxygen demand of the working muscle may result in reduced SmO₂ levels. SmO₂ is influenced by shifts in the hemoglobin dissociation curve as well as by other chemical and neural factors.
1 secondary outcome
upper extremity muscle strength
Time frame: october 2026 to august 2027
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Sep 2026.
- Individual participant dataSharing planned: No. There are currently no plans to share individual participant data with other researchers. Study results will be reported only in aggregated form, and no personally identifiable information will be disclosed.
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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.
Atiye KAŞ ÖZDEMİR, Lecturer, PhD. principal investigator
Pamukkale University
Sevda YILMAZ, Assoc. Prof. Dr. study chair
Pamukkale University
Orçin TELLİ ATALAY, Prof. Dr. study chair
Pamukkale University
Questions about this trial
What is this clinical trial studying?
An observational study of Breast Cancer Survivors, run by Pamukkale University.
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 5 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: opening soon, as of the sponsor's last update on 14 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Atiye KAŞ ÖZDEMİR, Lecturer PhD (+905364720293, akas@pau.edu.tr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Muscle oxygenation will be assessed a noninvasive technique, using near-infrared spectroscopy (NIRS). NIRS can measure local muscle oxygen saturation (SmO₂) in the capillary bed of the underlying muscle tissue. (time frame: october 2026 to august 2027). 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 14 Sep 2026.