Back to resultsUrtica Comp. Gel for Prevention and Therapy of Radiation Dermatitis (Urticacomp)
Primary Purpose
Radiation Dermatitis
Status
Completed
Phase
Phase 2
Locations
Switzerland
Study Type
Interventional
Intervention
Urtica comp. gel
institutional standard skin care "Excipial-Hydrolotion"
Sponsored by
About this trial
This is an interventional treatment trial for Radiation Dermatitis focused on measuring Radiation Dermatitis, Urtica comp.
Eligibility Criteria
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.
Sites / Locations
- Universitätsklinik für Radio-Onkologie
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Test group
Control group
Arm Description
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).
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.
Outcomes
Primary Outcome Measures
Incidence of Radiation Dermatitis (RD) measured by the CTCAE
Comparison between both arms
Severity of RD measured by the CTCAE
Comparison between both arms
Secondary Outcome Measures
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)
Percentage of patients RD free at end of therapy (EOT) measured by the CTCAE
Comparison between both arms
Percentage of patients with secondary skin infection / need of topical and systemic antibiotics
Comparison between both arms
Patients quality of life measured by the Skindex
Comparison between both arms.
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).
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).
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03494205
Brief Title
Urtica Comp. Gel for Prevention and Therapy of Radiation Dermatitis
Acronym
Urticacomp
Official Title
Urtica Comp. Gel for Prevention and Therapy of Radiation Dermatitis (An Interdisciplinary, Interprofessional Phase II Randomized Controlled Trial in Patients With Breast Cancer)
Study Type
Interventional
2. Study Status
Record Verification Date
May 2022
Overall Recruitment Status
Completed
Study Start Date
May 2, 2018 (Actual)
Primary Completion Date
February 10, 2022 (Actual)
Study Completion Date
February 10, 2022 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Bern
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
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
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Radiation Dermatitis
Keywords
Radiation Dermatitis, Urtica comp.
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Model Description
randomized parallel design
Masking
None (Open Label)
Allocation
Randomized
Enrollment
31 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Test group
Arm Type
Experimental
Arm Description
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).
Arm Title
Control group
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
Urtica comp. gel
Other Intervention Name(s)
Wund- und Brand Gel
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
institutional standard skin care "Excipial-Hydrolotion"
Other Intervention Name(s)
Excipial
Intervention Description
The institutional standard skin care "Excipial-Hydrolotion" is available to all patients
Primary Outcome Measure Information:
Title
Incidence of Radiation Dermatitis (RD) measured by the CTCAE
Description
Comparison between both arms
Time Frame
During the whole study (six weeks of therapy plus follow-up of six weeks)
Title
Severity of RD measured by the CTCAE
Description
Comparison between both arms
Time Frame
During the whole study (six weeks of therapy plus follow-up of six weeks)
Secondary Outcome Measure Information:
Title
Percentage of patients requiring no additional therapy for RD (e.g. Flammazine or Ialugen plus)
Description
Comparison between both arms measuring the use of Flammazine or Ialugen plus (rescue-care)
Time Frame
During the whole study (six weeks of therapy plus follow-up of six weeks)
Title
Percentage of patients RD free at end of therapy (EOT) measured by the CTCAE
Description
Comparison between both arms
Time Frame
EOT (=time point specifically at end of 6 weeks of radiation therapy)
Title
Percentage of patients with secondary skin infection / need of topical and systemic antibiotics
Description
Comparison between both arms
Time Frame
During the whole study (six weeks of therapy plus follow-up of six weeks)
Title
Patients quality of life measured by the Skindex
Description
Comparison between both arms.
Time Frame
During the whole study (six weeks of therapy plus follow-up of six weeks)
Title
Patients evaluation of the treatment (satisfaction) measured by the FACIT-TS-G (total scale)
Description
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).
Time Frame
EOT (=time point specifically at end of 6 weeks of radiation therapy)
Title
Patients evaluation of the treatment (Skin condition) measured by visual analog scale (VAS)
Description
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).
Time Frame
During the whole study (six weeks of therapy plus follow-up of six weeks)
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ursula Wolf
Organizational Affiliation
University Bern, Institution of Complementary Medicine
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Nikola Cihoric, MD PhD
Organizational Affiliation
University Bern, Department of Radiation Oncology
Official's Role
Principal Investigator
Facility Information:
Facility Name
Universitätsklinik für Radio-Onkologie
City
Bern
ZIP/Postal Code
3010
Country
Switzerland
12. IPD Sharing Statement
Plan to Share IPD
No
IPD Sharing Plan Description
Individual Patient data will not be shared.
Learn more about this trial
Urtica Comp. Gel for Prevention and Therapy of Radiation Dermatitis
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