Urtica Comp. Gel for Prevention and Therapy of Radiation Dermatitis

NCT03494205 | Completed Phase 2

• 1 other identifier: 211820931
• Study Type: interventional
• Target: 31
• Locations: 1 country
• Sites: 1

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.

Conditions

Radiation Dermatitis

Keywords

Radiation Dermatitis; Urtica comp.

Outcome Measures

Primary Outcomes (2)

• Incidence of Radiation Dermatitis (RD) measured by the CTCAE

  Comparison between both arms

  During the whole study (six weeks of therapy plus follow-up of six weeks)

• Severity of RD measured by the CTCAE

  Comparison between both arms

  During the whole study (six weeks of therapy plus follow-up of six weeks)

Secondary Outcomes (6)

• Percentage of patients requiring no additional therapy for RD (e.g. Flammazine or Ialugen plus)

  During the whole study (six weeks of therapy plus follow-up of six weeks)

• Percentage of patients RD free at end of therapy (EOT) measured by the CTCAE

  EOT (=time point specifically at end of 6 weeks of radiation therapy)

• Percentage of patients with secondary skin infection / need of topical and systemic antibiotics

  During the whole study (six weeks of therapy plus follow-up of six weeks)

• Patients quality of life measured by the Skindex

  During the whole study (six weeks of therapy plus follow-up of six weeks)

• Patients evaluation of the treatment (satisfaction) measured by the FACIT-TS-G (total scale)

  EOT (=time point specifically at end of 6 weeks of radiation therapy)

Study Arms (2)

Test group

EXPERIMENTAL

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

Control group

ACTIVE COMPARATOR

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"

Interventions

Urtica comp. gel 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.

Also known as: Wund- und Brand Gel

Test group

institutional standard skin care "Excipial-Hydrolotion" DRUG

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

Also known as: Excipial

Control group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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
• 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.

Sponsors & Collaborators

• University of Bern: lead

Study Sites (1)

Universitätsklinik für Radio-Onkologie

Bern, 3010, Switzerland

Location

MeSH Terms

Conditions

Radiodermatitis

Condition Hierarchy (Ancestors)

Dermatitis; Skin Diseases; Skin and Connective Tissue Diseases; Radiation Injuries; Wounds and Injuries

Study Officials

• Ursula Wolf

  University Bern, Institution of Complementary Medicine

  STUDY DIRECTOR

• Nikola Cihoric, MD PhD

  University Bern, Department of Radiation Oncology

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: randomized parallel design

Study Record Dates

• First Submitted: February 22, 2018
• First Posted: April 11, 2018
• Study Start: May 2, 2018
• Primary Completion: February 10, 2022
• Study Completion: February 10, 2022
• Last Updated: May 27, 2022

Record last verified: 2022-05

Data Sharing

• IPD Sharing: Will not share

Locations

CH (1)