Evaluation of a Novel Skin Care Product for the Management of Acute Radiodermatitis in Breast Cancer Patients
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 100
- 试验地点
- 2
- 主要终点
- Skin reaction evaluation
研究概览
简要总结
Notwithstanding the continuous progress in cancer treatment, patients with cancer still have to cope with quality of life (QoL) - impairing complications. Especially an extensive spectrum of dermatologic toxicities has been associated with cancer treatments. The number and type of cutaneous toxicities have evolved over the past 50 years, paralleling the development of new radiotherapy (RT) techniques. Acute radiodermatitis (ARD) is a distressing and painful skin reaction that occurs in 95% of the patients undergoing RT.
Important organizations in the field of oncology and supportive care, such as the MASCC, the ASCO, and the ESMO, have developed guidelines for the management of cancer therapy- related cutaneous toxicities based on available scientific evidence. Still, for some interventions, the evidence of recommendation is moderate to insufficient. Therefore, it is essential to elucidate other new potential management strategies for dermatological complications of cancer treatment. Based on the previously mentioned supportive care guidelines for the RTskin project, a novel emollient to tackle ARD has been developed.
The RTskin project general aim is to evaluate the efficacy of a novel skincare product to manage ARD in breast cancer patients.
详细描述
Primary objective Evaluate the efficacy of a novel emollient for the management of ARD in comparison with the current standard of care in breast cancer patients
Secondary Objective 1 Compare the ARD-related symptoms of in breast cancer patients treated with the novel emollient and the standard institutional skin care.
Secondary Objective 2 Compare the dermatologic quality of life of in breast cancer patients treated with the novel emollient and the standard institutional skin care.
Secondary Objective 3 Correlate the severity of ARD with the applied RT parameters and personal - medical characteristics
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 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
- •Diagnosis of breast cancer and underwent lumpectomy or mastectomy
- •Scheduled for radiotherapy: hypofractionation regimen (16 or 16+5 boost fractions) at the Jessa Hospital (Hasselt, BE)
- •Age ≥ 18 years
- •Able to comply to the study protocol
- •Able to sign written informed consent
- •Signed written informed consent
排除标准
- •Previous irradiation to the breast region
- •Metastatic disease
- •Patients with pre-existing skin rash, ulceration or open wound in the treatment area
- •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
Skin reaction evaluation
时间窗: At fraction 20-21 of radiotherapy (week 4) in case of a tumor boost
The patients skin reactions will be evaluated by the modified version of the RTOG criteria
次要结局
- Patient subjective evaluation of skin reactions(At fraction 20/21 of radiotherapy (week 4) in case of a tumor boost)
- Quality of life assessment(At fraction 20/21 of radiotherapy (week 4) in case of a tumor boost)
- Patients' satisfaction with the therapeutic intervention(At fraction 20/21 of radiotherapy (week 4) in case of a tumor boost)
- Pruritus evaluation(At fraction 20/21 of radiotherapy (week 4) in case of a tumor boost)