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Muscle Oxygenation and Function in Breast Cancer Survivors

9 сентября 2026 г. обновлено: ATİYE KAŞ ÖZDEMİR, Pamukkale University

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.

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.

Обзор исследования

Статус

Еще не набирают

Условия

Тип исследования

Наблюдательный

Регистрация (Оцененный)

80

Контакты и местонахождение

В этом разделе приведены контактные данные лиц, проводящих исследование, и информация о том, где проводится это исследование.

Контакты исследования

  • Имя: Atiye KAŞ ÖZDEMİR, Lecturer PhD
  • Номер телефона: +905364720293
  • Электронная почта: akas@pau.edu.tr

Критерии участия

Исследователи ищут людей, которые соответствуют определенному описанию, называемому критериям приемлемости. Некоторыми примерами этих критериев являются общее состояние здоровья человека или предшествующее лечение.

Критерии приемлемости

Возраст, подходящий для обучения

  • Взрослый
  • Пожилой взрослый

Принимает здоровых добровольцев

Да

Метод выборки

Невероятностная выборка

Исследуемая популяция

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

Описание

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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

Учебный план

В этом разделе представлена ​​подробная информация о плане исследования, в том числе о том, как планируется исследование и что оно измеряет.

Как устроено исследование?

Детали дизайна

Когорты и вмешательства

Группа / когорта
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

Что измеряет исследование?

Первичные показатели результатов

Мера результата
Мера Описание
Временное ограничение
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.
Временное ограничение: 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.
october 2026 to august 2027

Вторичные показатели результатов

Мера результата
Мера Описание
Временное ограничение
upper extremity muscle strength
Временное ограничение: october 2026 to august 2027
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).
october 2026 to august 2027

Другие показатели результатов

Мера результата
Мера Описание
Временное ограничение
Functional performance of upper extremity
Временное ограничение: october 2026 to august 2027
Upper extremity functional exercise capacity will be assessed using the Six-Minute Pegboard and Ring Test. Participants will sit on an adjustable chair in front of a pegboard consisting of two lower horizontal bars positioned at shoulder height and shoulder width, one on the right and one on the left, and two upper bars positioned 20 cm above the lower bars. Each upper bar will contain 10 rings. Participants will be instructed to transfer the rings from the lower bars to the upper bars and then back to the lower bars as quickly as possible, using both arms simultaneously. If a participant requires rest, they will be permitted to rest while the test duration continues, with instructions to resume the test as soon as possible. The number of rings transferred during the 6-minute test will be recorded. Two rings removed and placed simultaneously will be counted as two rings.Blood pressure, heart rate, and peripheral oxygen saturation will be recorded before and immediately after the test.
october 2026 to august 2027
upper extremity disability
Временное ограничение: october 2026 to august 2027

Upper extremity disability will be assessed using the Disabilities of the Arm, Shoulder and Hand Questionnaire-Quick Version (QuickDASH). The Turkish version of the QuickDASH, which has been demonstrated to be valid and reliable, will be used. The QuickDASH consists of 11 items, with each item scored on a 5-point scale ranging from 1 to 5 (1 = no difficulty, 2 = mild difficulty, 3 = moderate difficulty, 4 = severe difficulty, and 5 = unable to perform). The questionnaire assesses pain severity, activity-related pain, tingling, weakness, stiffness, difficulty performing physical activities due to upper extremity problems, and the impact of upper extremity problems on social activities, work, and sleep.

The QuickDASH score ranges from 0 to 100, with higher scores indicating greater disability (0 = no disability; 100 = maximum disability). A score of ≥20 indicates clinically significant functional impairment.
october 2026 to august 2027

Соавторы и исследователи

Здесь вы найдете людей и организации, участвующие в этом исследовании.

Спонсор

Pamukkale University

Следователи

  • Главный следователь: Atiye KAŞ ÖZDEMİR, Lecturer, PhD., Pamukkale University
  • Учебный стул: Sevda YILMAZ, Assoc. Prof. Dr., Pamukkale University
  • Учебный стул: Orçin TELLİ ATALAY, Prof. Dr., Pamukkale University

Даты записи исследования

Эти даты отслеживают ход отправки отчетов об исследованиях и сводных результатов на сайт ClinicalTrials.gov. Записи исследований и сообщаемые результаты проверяются Национальной медицинской библиотекой (NLM), чтобы убедиться, что они соответствуют определенным стандартам контроля качества, прежде чем публиковать их на общедоступном веб-сайте.

Изучение основных дат

Начало исследования (Оцененный)

1 октября 2026 г.

Первичное завершение (Оцененный)

1 августа 2027 г.

Завершение исследования (Оцененный)

1 ноября 2027 г.

Даты регистрации исследования

Первый отправленный

30 августа 2026 г.

Впервые представлено, что соответствует критериям контроля качества

9 сентября 2026 г.

Первый опубликованный (Действительный)

14 сентября 2026 г.

Обновления учебных записей

Последнее опубликованное обновление (Действительный)

14 сентября 2026 г.

Последнее отправленное обновление, отвечающее критериям контроля качества

9 сентября 2026 г.

Последняя проверка

1 августа 2026 г.

Дополнительная информация

Термины, связанные с этим исследованием

Ключевые слова

Другие идентификационные номера исследования

  • 2026TAP034 (Другой номер гранта/финансирования: Pamukkale University Scientific Research Projects Department)

Планирование данных отдельных участников (IPD)

Планируете делиться данными об отдельных участниках (IPD)?

НЕТ

Описание плана IPD

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.

Информация о лекарствах и устройствах, исследовательские документы

Изучает лекарственный продукт, регулируемый FDA США.

Нет

Изучает продукт устройства, регулируемый Управлением по санитарному надзору за качеством пищевых продуктов и медикаментов США.

Нет

Эта информация была получена непосредственно с веб-сайта clinicaltrials.gov без каких-либо изменений. Если у вас есть запросы на изменение, удаление или обновление сведений об исследовании, обращайтесь по адресу register@clinicaltrials.gov. Как только изменение будет реализовано на clinicaltrials.gov, оно будет автоматически обновлено и на нашем веб-сайте. .

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