Evaluating the Feasibility and Efficacy of Photobiomodulation Therapy in the Prevention and Management of Radiotherapy-induced Vaginal Toxicity: 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
- 62
- 试验地点
- 4
- 主要终点
- CTCAE-score
研究概览
简要总结
This study aims to investigate the effectiveness of photobiomodulation therapy (PBMT) in the prevention and management of radiotherapy-induced vaginal toxicity (RIVT). Therefore, we hypothesize that PBMT can reduce the severity of RIVT in gynecological cancer patients, increasing the patient's QoL and sexual functioning.
详细描述
The global cancer burden keeps rising, and the accompanied side effects remain a significant concern. This project focuses on one of such complications: radiotherapy-induced vaginal toxicity (RIVT). The use of external and internal radiotherapy in gynecological cancers can severely impact the patient's vaginal function. This influences the patient's quality of life (QoL), as it significantly limits sexual intercourse and further physical examination. Management of RIVT urgently requires a comprehensive approach. Photobiomodulation therapy (PBMT) is a non-invasive form of phototherapy that utilizes visible and/or near-infrared light to trigger a cascade of intracellular reactions. PBMT can be used to improve wound healing, and to reduce pain, inflammation, and edema. Literature shows that PBMT can be used for treating the genitourinary syndrome of menopause as it stimulates the synthesis of collagen and elastin and promotes vasodilation in the vaginal submucosa. To date, no clinical trials have investigated the positive effects of PBMT on RIVT.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- None
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 endometrial cancer
- •Scheduled for external beam radiotherapy (EBRT), intracavitary brachytherapy (BT), or a combination
- •Age ≥ 18 years
- •Able to comply to the study protocol
- •Able to sign written informed consent
排除标准
- •Metastatic disease
- •Pregnancy
- •Diagnosis of vaginal stenosis before radiotherapy (RT)
- •Previous pelvic tumor or pelvic RT
- •Interruption of RT for more than five sessions
- •Severe psychological disorder or dementia.
- •Inability to speak and understand Dutch
- •Substance abuse patients or patients with medical, psychological or social conditions that may interfere with the patient's participation in the study or evaluation of the study results as judged by the investigator
- •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
CTCAE-score
时间窗: Three months post radiotherapy
The physician will score the patient's vaginal dryness, discharge, inflammation, stricture, pain and hemorrhage according to the Common Terminology Criteria for Adverse Events (CTCAE)
RIVT symptoms
时间窗: One year post radiotherapy
The patient will score their symptoms (dryness, pruritus, discharge, hemorrhage and a burning sensation) via a NRS ranging from 0 (symptom absent) to 10 (most severe form).
次要结局
- Vaginal health index (VHI)(Three months post radiotherapy)
- Quality of Life score(One year post radiotherapy)
- Sexual distress score(One year post radiotherapy)
- Satisfaction score(One year post radiotherapy)
- Pain score(One year post radiotherapy)
- Sexual functioning score(One year post radiotherapy)