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

Radiation Dermatitis Clinical Trial

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)

Clinical Trial 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.

Clinical Trial 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 Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT03494205
Study type Interventional
Source University of Bern
Contact
Status Completed
Phase Phase 2
Start date May 2, 2018
Completion date February 10, 2022
View Details
See also
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