Retrospective Analysis of the Efficacy of Morphine Gel (MG) for the Treatment of Pain Associated With RadioDermatitis (RD) More Than Grade II
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 17
- 试验地点
- 1
- 主要终点
- Efficacy of morphine gel (GM) in the treatment of pain in perineal radiodermatitis
研究概览
简要总结
Retrospective study evaluating the efficacy of a pharmacy-prepared Morphine gel used in clinics for the treatment of pain associated with perineal radiodermatitis. The main aim of this study is to evaluate the efficacy of Morphine Gel (MG) in pain management.
详细描述
Radiotherapy (RT) can induce acute side effects or toxicities, known as radiodermatitis (RD). Technological and technical advances have made it possible to reduce these toxicities (1), although certain organs such as the skin and mucous membranes remain vulnerable, particularly when the tumor is located nearby.
Skin exposed to ionizing radiation (IR) during the treatment of tumors close to the cutaneous surface is no longer able to renew itself due to an alteration in the basal cell mitotic process, leading to suppression of skin cell renewal. IR also induces senescence of epidermal keratinocytes, responsible for exacerbated inflammatory activity and structural dysfunction of the epidermal barrier, through disruption of the keratinization and cornification process. (2).
RD usually heals ad integrum. They are classified into 5 grades according to the Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0 (3), presenting different clinical aspects ranging from grade I to V.
Grade II and III RDs are frequently observed in patients undergoing perineal RT, especially as medical treatment is associated.
In addition to the tumor's proximity to the skin, several anatomical factors specific to the perineal region contribute to the occurrence of these RDs: a wetter area, with skin folds, subject to friction and the presence of the urinary and anal orifices, potential sources of irritation by the elimination of urine and feces.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Retrospective
入排标准
- 年龄范围
- 18 Years 至 100 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients 18 years and older;
- •Use of a local analgesic treatment based on Morphine gel for pain associated with perineal radiodermatitis.
- •Patients not relieved by prescribed systemic treatments (per-os or intravenous)
- •Patients treated with radiotherapy for a perineal tumor, whether or not associated with medical treatment such as chemotherapy.
- •Minimum grade of radiodermatitis: Grade II
排除标准
- •Patients who have not used the prescribed morphine gel
- •Minor patients
- •Patients using morphine gel for wounds other than radiodermatitis
- •Patients who object to the re-use of their data
研究组 & 干预措施
Patients using morphine gel
patients who received morphine gel to treat pain due to perineal radiodermatitis
干预措施: morphine chlorhydrate in intrasite gel (Drug)
结局指标
主要结局
Efficacy of morphine gel (GM) in the treatment of pain in perineal radiodermatitis
时间窗: between baseline and day2 to day21
Reduced pain as assessed by the patient. Verbal scale to qualify the evolution of the pain (decreased - stable - increased)
次要结局
- Assessment of systemic analgesic prescribed(between baseline and day2 to day 21)
- Interruption of radiotherapy treatment in connection with radiodermatitis(during 5 weeks from first day of radiotherapy (throught radiotherapy completion))