Evaluating the Effectiveness of Photobiomodulation Therapy in the Management of Breast Cancer-Related Lymphedema: a Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 104
- 试验地点
- 4
- 主要终点
- Activity and participation
研究概览
简要总结
Up to one out of five patients with breast cancer will develop lymphedema in the upper extremity after cancer treatment. Patients with breast cancer-related lymphedema (BCRL) suffer from pain, heaviness, tightness, and a decreased range of motion. Photobiomodulation therapy (PBMT) is a non-invasive therapy based on the application of visible and/or near-infrared light produced by a laser diode or a light-emitting diode. The scientifically proven biologic effects of PBM are improved wound healing, and a reduction in pain, inflammation, and oedema. Therefore, the aim of this study is to evaluate the effectiveness of PBMT on the management of BCRL.
详细描述
This aim of this study is to determine the efficacy of PBMT in combination with the institutional therapy on the management of BCRL. Therefore, we hypothesize that PBMT in combination with manual lymphatic drainage is able to reduce the limb circumference and the associated pain and improve the QoL of patients with BCRL during treatment and up to 12 months post-treatment.
Primary Objective 1: Arm circumference
The study seeks primarily to determine the effectiveness PBMT and manual lymphatic drainage in reducing the arm circumference in patients with established BCRL during PBM treatment and up to 12 months post-PBMT.
Primary Objective 2: Activity and participation
Another primary aim of this study is to evaluate the effectiveness of PBMT and manual lymphatic drainage in the enhancement of the patients' activity and participation status.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
盲法说明
Single : outcome assessor
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Diagnosed with breast cancer
- •Underwent ipsilateral lumpectomy or mastectomy + sentinel lymph node biopsy +/- lymph node dissection
- •Underwent radiotherapy with or without chemotherapy
- •Diagnosed with BCRL (i.e. International Society of Lymphology (ISL) lymphedema stage I or higher)
- •Age ≥ 18 years
- •Able to comply to the study protocol
- •Able to sign written informed consent
排除标准
- •Metastatic disease
- •Pregnancy
- •History of surgery or trauma to the arm
- •History of arm infection in the past 3 months
- •Use of medications that affect body fluid (e.g., diuretics) in the last 3 months
- •Severe psychological disorder or dementia
- •Any condition that is unstable or could affect the safety of the patient and their compliance in the study as judged by the investigator
结局指标
主要结局
Activity and participation
时间窗: 12 month follow-up
The Disabilities of the Arm, Shoulder and Hand (DASH) questionnaire is a 30-item questionnaire that looks at the ability of a patient to perform certain upper extremity activities. The score can range from 0 (no disability) to 100 (most severe disability).
ISL classification
时间窗: 12 month follow-up
The severity of BCRL will be evaluated using the ISL criteria. This will be performed by the treating physician.
Arm circumference and volume
时间窗: 12 month follow-up
The arm circumferences will be measured at olecranon and at 4, 8, 12, 16 and 20 cm proximal and distal of olecranon. The circumference at each point will be recorded in cm. The calculated arm volume will be estimated by the formula of the truncated cone of each 4 cm segment proximal (towards the wrist) and distal (towards the acromion) from the olecranon. The following truncated cone formula was used: 4 \* (C1\* C1 +C1\*C2+C2\*C2)/12π C1 is the upper circumference and C2 is the lower circumference of each segment. The calculated volume of whole arm is the sum of the volume of all segments of the arm expressed in kubic centimeter
Arm mobility measurement
时间窗: 12 month follow-up
A standard plastic goniometer will be used to measure active range of mobility (ROM) for shoulder flexion, abduction, and external rotation.
次要结局
- Patients' satisfaction with the therapeutic intervention(12 month follow-up)
- Pain assessment(12 month follow-up)
- Quality of life assessment(12 month follow-up)
- Depression, anxiety and stress(12 month follow-up)