Urtica Comp. Gel for Prevention and Therapy of Radiation Dermatitis (Urticacomp)
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT03494205|
Recruitment Status : Recruiting
First Posted : April 11, 2018
Last Update Posted : July 8, 2019
|Condition or disease||Intervention/treatment||Phase|
|Radiation Dermatitis||Drug: Urtica comp. gel Drug: institutional standard skin care "Excipial-Hydrolotion"||Phase 2|
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 :||Interventional (Clinical Trial)|
|Estimated Enrollment :||30 participants|
|Intervention Model:||Parallel Assignment|
|Intervention Model Description:||randomized parallel design|
|Masking:||None (Open Label)|
|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)|
|Actual Study Start Date :||May 2, 2018|
|Estimated Primary Completion Date :||June 2020|
|Estimated Study Completion Date :||August 2020|
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).
Drug: Urtica comp. gel
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 Name: Wund- und Brand Gel
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.
Drug: institutional standard skin care "Excipial-Hydrolotion"
The institutional standard skin care "Excipial-Hydrolotion" is available to all patients
Other Name: Excipial
- 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
- 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
- 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)
- 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
- 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
- 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.
- 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).
- 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).
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03494205
|Contact: Gisa A Gerstenberg, MD PhD||+41 (0)31 631 ext firstname.lastname@example.org|
|Contact: Ursula Wolf, MD PhD||+41 (0)31 631 ext email@example.com|
|Universitätsklinik für Radio-Onkologie||Recruiting|
|Bern, Switzerland, 3010|
|Contact: Nikola Cihoric, M.D. 031 632 29 32 firstname.lastname@example.org|
|Study Director:||Ursula Wolf||University Bern, Institution of Complementary Medicine|
|Principal Investigator:||Nikola Cihoric, MD PhD||University Bern, Department of Radiation Oncology|