- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03494205
Urtica Comp. Gel for Prevention and Therapy of Radiation Dermatitis (Urticacomp)
Urtica Comp. Gel for Prevention and Therapy of Radiation Dermatitis (An Interdisciplinary, Interprofessional Phase II Randomized Controlled Trial in Patients With Breast Cancer)
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
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.
Study Type
Enrollment (Actual)
Phase
- Phase 2
Contacts and Locations
Study Locations
-
-
-
Bern, Switzerland, 3010
- Universitätsklinik für Radio-Onkologie
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: 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). |
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.
Other Names:
|
Active Comparator: 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.
|
The institutional standard skin care "Excipial-Hydrolotion" is available to all patients
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Incidence of Radiation Dermatitis (RD) measured by the CTCAE
Time Frame: During the whole study (six weeks of therapy plus follow-up of six weeks)
|
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
Time Frame: During the whole study (six weeks of therapy plus follow-up of six weeks)
|
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)
Time Frame: During the whole study (six weeks of therapy plus follow-up of six weeks)
|
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
Time Frame: EOT (=time point specifically at end of 6 weeks of radiation therapy)
|
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
Time Frame: During the whole study (six weeks of therapy plus follow-up of six weeks)
|
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
Time Frame: During the whole study (six weeks of therapy plus follow-up of six weeks)
|
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)
Time Frame: EOT (=time point specifically at end of 6 weeks of radiation therapy)
|
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)
Time Frame: During the whole study (six weeks of therapy plus follow-up of six weeks)
|
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)
|
Collaborators and Investigators
Sponsor
Investigators
- Study Director: Ursula Wolf, University Bern, Institution of Complementary Medicine
- Principal Investigator: Nikola Cihoric, MD PhD, University Bern, Department of Radiation Oncology
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 211820931
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Radiation Dermatitis
-
Chang Gung Memorial HospitalNot yet recruiting
-
German University in CairoAin Shams UniversityCompleted
-
China Medical University HospitalCompletedRadiation DermatitisTaiwan
-
Sheba Medical CenterFerring PharmaceuticalsCompleted
-
Apeiron BiologicsCompleted
-
Lutris Pharma Ltd.CompletedRadiation DermatitisUnited States
-
University of RochesterNational Cancer Institute (NCI)CompletedRadiation-induced Dermatitis
-
University of the PhilippinesRecruitingAcute Radiation DermatitisPhilippines
-
China Medical University HospitalNot yet recruitingBreast Cancer | Radiation Dermatitis
-
Pharm Olam Pharmaceuticals Ltd.UnknownPrevention of Radiation Induced Dermatitis.
Clinical Trials on Urtica comp. gel
-
Assistance Publique - Hôpitaux de ParisWithingsNot yet recruitingLymphoma, Non-Hodgkin | Myeloma Multiple
-
University of South CarolinaUnknown
-
Assistance Publique - Hôpitaux de ParisHotel Dieu Hospital; Withings; Hôpital Lariboisière Fernand WidalNot yet recruiting
-
VA Office of Research and DevelopmentCompletedHearing Loss | Cisplatin OtotoxicityUnited States
-
University of California, Los AngelesRecruitingAging | Endothelial Dysfunction | SenescenceUnited States
-
Shahid Beheshti University of Medical SciencesCompletedType 2 Diabetes MellitusIran, Islamic Republic of
-
Assistance Publique - Hôpitaux de ParisWithingsNot yet recruiting
-
Charite University, Berlin, GermanyWALA Heilmittel GmbHCompletedChronic Low Back PainGermany
-
ChimerixTerminated