Urtica Comp. Gel for Prevention and Therapy of Radiation Dermatitis

NCT ID: NCT03494205

Last Updated: 2022-05-27

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 31 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-05-02
• Study Completion Date: 2022-02-10

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.

Conditions

Radiation Dermatitis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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).

Group Type: EXPERIMENTAL

Urtica comp. gel

Intervention Type: DRUG

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.

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.

Group Type: ACTIVE_COMPARATOR

institutional standard skin care "Excipial-Hydrolotion"

Intervention Type: DRUG

The institutional standard skin care "Excipial-Hydrolotion" is available to all patients

Interventions

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.

Intervention Type: DRUG

institutional standard skin care "Excipial-Hydrolotion"

The institutional standard skin care "Excipial-Hydrolotion" is available to all patients

Intervention Type: DRUG

Other Intervention Names

Wund- und Brand Gel; Excipial

Eligibility Criteria

Inclusion Criteria

• Radiation therapy for Breast Cancer
• Age >= 18 years
• Written informed consent

• 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.

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Bern

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Ursula Wolf

Role: STUDY_DIRECTOR

University Bern, Institution of Complementary Medicine

Nikola Cihoric, MD PhD

Role: PRINCIPAL_INVESTIGATOR

University Bern, Department of Radiation Oncology

Locations

Universitätsklinik für Radio-Onkologie

Bern, , Switzerland

Countries

Switzerland

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

211820931

Identifier Type: -

Identifier Source: org_study_id