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Urtica Comp. Gel for Prevention and Therapy of Radiation Dermatitis (Urticacomp)

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ClinicalTrials.gov Identifier: NCT03494205
Recruitment Status : Recruiting
First Posted : April 11, 2018
Last Update Posted : January 16, 2019
Sponsor:
Information provided by (Responsible Party):
University of Bern

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.

Condition or disease Intervention/treatment Phase
Radiation Dermatitis Drug: Urtica comp. gel Drug: institutional standard skin care "Excipial-Hydrolotion" Phase 2

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.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: randomized parallel design
Masking: None (Open Label)
Primary Purpose: Treatment
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 2019
Estimated Study Completion Date : August 2019

Resource links provided by the National Library of Medicine


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).

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




Primary Outcome Measures :
  1. 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

  2. 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


Secondary Outcome Measures :
  1. 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)

  2. 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

  3. 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

  4. 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.

  5. 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).


  6. 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).




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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

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


Contacts
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Contact: Gisa A Gerstenberg, MD PhD +41 (0)31 631 ext 8140 gisa.gerstenberg@ikom.unibe.ch
Contact: Ursula Wolf, MD PhD +41 (0)31 631 ext 8140 ursula.wolf@ikom.unibe.ch

Locations
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Switzerland
Universitätsklinik für Radio-Onkologie Recruiting
Bern, Switzerland, 3010
Contact: Nikola Cihoric, M.D.    031 632 29 32    nikola.cihoric@insel.ch   
Sponsors and Collaborators
University of Bern
Investigators
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Study Director: Ursula Wolf University Bern, Institution of Complementary Medicine
Principal Investigator: Nikola Cihoric, MD PhD University Bern, Department of Radiation Oncology
  Study Documents (Full-Text)

Documents provided by University of Bern:

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Responsible Party: University of Bern
ClinicalTrials.gov Identifier: NCT03494205     History of Changes
Other Study ID Numbers: 211820931
First Posted: April 11, 2018    Key Record Dates
Last Update Posted: January 16, 2019
Last Verified: January 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: individual Patient data will not be shared.

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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

Keywords provided by University of Bern:
Radiation Dermatitis
Urtica comp.

Additional relevant MeSH terms:
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Dermatitis
Radiodermatitis
Skin Diseases
Radiation Injuries
Wounds and Injuries