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临床试验/NCT07818811
NCT07818811尚未招募不适用

Upper Extremity Muscle Oxygenation Dynamics and Functional Performance in Breast Cancer Survivors

Pamukkale University0 个研究点目标入组 80 人开始时间: 2026年10月1日最近更新:
适应症

试验速览

阶段
不适用
状态
尚未招募
入组人数
80
主要终点
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.

研究概览

简要总结

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.

研究设计

研究类型
Observational
观察模型
Other
时间视角
Cross Sectional

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
Female
接受健康志愿者

入选标准

  • 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

排除标准

  • 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

研究组 & 干预措施

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

结局指标

主要结局

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.

时间窗: 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.

次要结局

  • upper extremity muscle strength(october 2026 to august 2027)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

ATİYE KAŞ ÖZDEMİR

Lecturer PHd

Pamukkale University

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