Urtica Comp. Gel for Prevention and Therapy of Radiation Dermatitis

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Urtica Comp. Gel for Prevention and Therapy of Radiation Dermatitis (An Interdisciplinary, Interprofessional Phase II Randomized Controlled Trial in Patients With Breast Cancer)

Conditions
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Radiation Dermatitis

Intervention / Treatment
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* Drug: Urtica comp. gel
* Drug: institutional standard skin care Excipial-Hydrolotion


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Radiation therapy for Breast Cancer Age >= 18 years Written informed consent Exclusion Criteria: 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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: randomized parallel design
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Test group<br>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). | Drug: Urtica comp. gel<br>* Urtica comp. gel is a Swissmedic registered medication. The scope of application of Urtica comp. is an imbalanced, affected process of skin-regeneration, in particular when stemming from an overdose of heat or light. It is applied in first and second-degree burn and scalding, sunburn, allergic and hyperergic (excessive) skin conditions (dermatoses), insect bites, abrasions and ulcers.<br>* Other names: Wund- und Brand Gel;|
| Active Comparator: Control group<br>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. | Drug: institutional standard skin care Excipial-Hydrolotion<br>* The institutional standard skin care Excipial-Hydrolotion is available to all patients<br>* Other names: Excipial;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of Radiation Dermatitis (RD) measured by the CTCAE | Comparison between both arms | During the whole study (six weeks of therapy plus follow-up of six weeks) | 
| Severity of RD measured by the CTCAE | Comparison between both arms | During the whole study (six weeks of therapy plus follow-up of six weeks) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of patients requiring no additional therapy for RD (e.g. Flammazine or Ialugen plus) | Comparison between both arms measuring the use of Flammazine or Ialugen plus (rescue-care) | 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 | Comparison between both arms | EOT (=time point specifically at end of 6 weeks of radiation therapy) | 
| Percentage of patients with secondary skin infection / need of topical and systemic antibiotics | Comparison between both arms | During the whole study (six weeks of therapy plus follow-up of six weeks) | 
| Patients quality of life measured by the Skindex | Comparison between both arms. | During the whole study (six weeks of therapy plus follow-up of six weeks) | 
| Patients evaluation of the treatment (satisfaction) measured by the FACIT-TS-G (total scale) | Comparison between both arms. The FACIT-TS-G (Functional Assessment of Chronic Illness Therapy treatment satisfaction - General) assesses the patients treatment satisfaction at the end of therapy (EOT after 6 weeks of Radiation therapy). The questionnaire consists of 8 questions, 3 of which are answered on a scale ranging from 0 (much worse) to 4 (much better), 3 questions ranging from 0 (not al all) to 3 (totally) and two questions which can be answered with 0 (no), 1(maybe) and 2 (yes). Thus on all scales a higher value represents a better outcome. The total score range is 0 (not satisfied at all) to 25 (highly satisfied). | EOT (=time point specifically at end of 6 weeks of radiation therapy) | 
| Patients evaluation of the treatment (Skin condition) measured by visual analog scale (VAS) | with the Skin Condition VAS the patient self-assesses the skin condition in the radiation area. The questionnaire consists of 5 subscales: pain, itching, burning, irritation, visual appearance. Each scale ranges from 0 (not apparent) to 100 (worst possible expression). For the total score all values are summed up and divided by 5 (number of scales) resulting in a total score ranging from 0 (best possible outcome = no skin affection due to radiation) to 100 (worst possible outcome). | During the whole study (six weeks of therapy plus follow-up of six weeks) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Radiation Dermatitis, Urtica comp.