Urtica Comp. Gel for Prevention and Therapy of Radiation Dermatitis (An Interdisciplinary, Interprofessional Phase II Randomized Controlled Trial in Patients With Breast Cancer)
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 31
- 试验地点
- 1
- 主要终点
- Incidence of Radiation Dermatitis (RD) measured by the CTCAE
研究概览
简要总结
A randomized controlled trial comparing Urtica comp. gel (Swissmedic listed medication in the category of "Anthroposophic Medication without Indication") against standard skin care, examining its effect in prevention and treatment of radiation dermatitis in breast cancer patients under Radiation therapy.
详细描述
Radiation dermatitis is one of the most common side effects of radiotherapy for cancer and affects around 95 % of patients receiving radiotherapy. Patients with breast cancer as well as patients with head and neck cancer are most frequently affected, due to the higher radiation dose to the skin, as compared to other cancer types.
Radiation dermatitis has a profound impact on the quality of a patient's life, due to pain and discomfort. Skin lesions bear a marked risk of infection. In addition, all these issues may be the cause of interruption of radiation therapy, resulting in inadequate disease treatment.
Despite a plentitude of studies researching local and systemic therapeutic approaches, currently no treatment (aside from local steroids which bear substantial side-effects) can be explicitly recommended.
Thus, further research, especially in therapeutic options with a positive side-effect spectrum would be highly beneficial.
Urtica comp. gel is a Swissmedic registered medication. It is e.g. applied in first and second-degree burn and scalding as well as sunburn and has been used in over 80 years with an excellent safety profile. Positive clinical experience in treating radiation dermatitis with Urtica comp. gel suggest studying this therapeutic option in a pilot trial.
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
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Radiation therapy for Breast Cancer
- •Age >= 18 years
- •Written informed consent
排除标准
- •Ulcerated cancer at beginning of radiation therapy
- •Skin lesions in the radiation area before start of radiation therapy
- •Known allergies, hypersensitivity or reactions against one of the constituents of the investigational product [5]
- •Any neurological or psychiatric conditions that, in the evaluation of the treating physician, deem the patient incapable to participate in the study
- •Other clinically significant concomitant disease states (e.g., renal failure, hepatic dysfunction, cardiovascular disease, etc.) as judged by the PI
- •The following criteria are exclusion criteria for the conduct of the radiation therapy, which is prerequisite for inclusion into the study. Thus, such patients will anyway not meet the inclusion criteria and are explicitly excluded from participation:
- •Women who are pregnant or breast feeding
- •Lack of safe contraception, defined as: Female participants of childbearing potential, not using and not willing to continue using a medically reliable method of contraception for the entire study duration, such as oral, injectable, or implantable contraceptives, or intrauterine contraceptive devices, or who are not using any other method considered sufficiently reliable by the investigator in individual cases.
- •Please note that female participants who are surgically sterilised / hysterectomised or post-menopausal for longer than 2 years are not considered as being of child bearing potential.
研究组 & 干预措施
Test group
For the patients of the test-group Urtica comp gel is applied three times per day locally on the skin as soon as the patient senses "itching, tingling" and/or reddening. Otherwise the skincare is exactly as the control group in line with the departments general guidelines.
In case of marked worsening, e.g. epitheliolysis, the patient may receive "Flammazine and Ialugen plus" as rescue-care.
Rescue care: according to the departments therapeutic guidelines patients will receive "Flammazine and/or Ialugen plus" as clinically indicated at the discretion of the treating physician (usually in cases of marked worsening of the skin condition like e.g. epitheliolysis).
干预措施: Urtica comp. gel (Drug)
Control group
Control group receiving the institutional standard skin care "Excipial-Hydrolotion" - all other therapeutic interventions, assessments and rescue-care will be the same in both groups.
干预措施: institutional standard skin care "Excipial-Hydrolotion" (Drug)
结局指标
主要结局
Incidence of Radiation Dermatitis (RD) measured by the CTCAE
时间窗: During the whole study (six weeks of therapy plus follow-up of six weeks)
Comparison between both arms
Severity of RD measured by the CTCAE
时间窗: During the whole study (six weeks of therapy plus follow-up of six weeks)
Comparison between both arms
次要结局
- Patients evaluation of the treatment (satisfaction) measured by the FACIT-TS-G (total scale)(EOT (=time point specifically at end of 6 weeks of radiation therapy))
- Percentage of patients requiring no additional therapy for RD (e.g. Flammazine or Ialugen plus)(During the whole study (six weeks of therapy plus follow-up of six weeks))
- Percentage of patients RD free at end of therapy (EOT) measured by the CTCAE(EOT (=time point specifically at end of 6 weeks of radiation therapy))
- Patients quality of life measured by the Skindex(During the whole study (six weeks of therapy plus follow-up of six weeks))
- Percentage of patients with secondary skin infection / need of topical and systemic antibiotics(During the whole study (six weeks of therapy plus follow-up of six weeks))
- Patients evaluation of the treatment (Skin condition) measured by visual analog scale (VAS)(During the whole study (six weeks of therapy plus follow-up of six weeks))