Dose-Response Curve: Interventions to Prevent and Treat Radiodermatitis (DRCPTR)

November 30, 2015 updated by: Elaine Barros Ferreira, University of Brasilia

Use of Chamomilla Recutita Gel and Urea Cream to Prevent and Treat Radiodermatitis: Phase 2 Study

Dose response curve to define the security and tolerable dose to be used for prevention and treatment of radiodermatitis in patients with breast or head and neck cancer.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

The study is being conducted in Center for High Complexity Oncology (CACON) located at the University Hospital of Brasília (HUB). Has as its target population subjects diagnosed with breast and head and neck cancer undergoing radiotherapy. Three doses of urea cream are being tested. Participants are subjected to simple randomization technique, in which the members of the study are directly allocated in groups set forth, without any intermediate step. Patients are identified, go to a nursing consultation for general orientations about treatment. After the consultation, patients are invited to participate in the study. The patient should express its acceptance through the informed consent form. Data are being collected through interviews and medical records. Patients are being evaluated during three weeks, considering the toxicity of the intervention and the beginning of radiodermatitis. To evaluate the skin reaction will be applied scale of the Radiation Therapy Oncology Group (RTOG) - Acute Radiation Morbidity Scoring Criteria, Common Terminology Criteria for Adverse Events (CTCAE) and Radiation-Induced Skin Reaction Assessment Scale (RISRAS). For reliable assessment and record of the evolution throughout the treatment and study, patients will be photographed weekly (D0, D5, D10, D15). Will be photographed major regions subject to evaluation: frontal, right side profile and left side profile with Photographic camera Nikon P510. The data will be inserted into Statistical Package for Social Sciences (SPSS), version 18.0, for the analysis.

Study Type

Interventional

Enrollment (Actual)

30

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Brazil
    • Distrito Federal
      • Brasilia, Distrito Federal, Brazil
        • University Hospital of Brasilia

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Being an adult, over the age of 18 years old
  • Owning diagnosis of breast or head and neck cancer
  • Being first referred to the radiotherapy protocol
  • Have absence of radiodermatitis and integrates skin to start radiotherapy
  • Not have presented anticipated reaction of hypersensitivity to chamomile or any plant of the family Asteraceae or Compositae or urea.
  • Demonstrate conditions to continue the intervention in their home environment when needed.

Exclusion Criteria:

  • Medical prescription for the procedure of data collection, some kind of intervention to prevent radiodermatitis.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: DOUBLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Urea Dose A
Topical application of the urea cream in concentration A. The product should be applied on the skin three times daily over 3 weeks.
Drug: Urea Dose A
Urea cream for topical use.
Other Names:
  • Urea cream
EXPERIMENTAL: Urea Dose B
Topical application of the urea cream in concentration B. The product should be applied on the skin three times daily over 3 weeks.
Drug: Urea Dose B
Urea cream for topical use.
Other Names:
  • Urea cream
EXPERIMENTAL: Urea Dose C
Topical application of the urea cream in concentration C. The product should be applied on the skin three times daily over 3 weeks.
Drug: Urea Dose C
Urea cream for topical use.
Other Names:
  • Urea cream.
EXPERIMENTAL: Chamomile Dose A
Topical application of chamomile recutita gel in concentration A. The product should be applied on the skin three times daily over 3 weeks.
Drug: Chamomile Dose A
Chamomile gel for topical use.
Other Names:
  • Chamomile gel
EXPERIMENTAL: Chamomile Dose B
Topical application of chamomile recutita gel in concentration B. The product should be applied on the skin three times daily over 3 weeks.
Drug: Chamomile Dose B
Chamomile gel for topical use.
Other Names:
  • Chamomile gel
EXPERIMENTAL: Chamomile Dose C
Topical application of chamomile recutita gel in concentration C. The product should be applied on the skin three times daily over 3 weeks.
Drug: Chamomile Dose C
Chamomile gel for topical use.
Other Names:
  • Chamomile gel

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Time of occurrence of Radiodermatitis
Time Frame: 3 weeks
Time of occurrence of Radiodermatitis according with the Radiation Therapy Oncology Group (RTOG).
3 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Indicators of toxicity
Time Frame: 3 weeks

Evaluate the tolerance and safety of the intervention according to the assessment of toxicity during the intervention.

To evaluate the toxicity will be considered signs and symptoms referable to the region of application of the product, such as skin rash, urticaria, vesicles, blisters, pustules, as well as the patient's report of discomfort, burning, stinging and itching.
3 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Brasilia

Collaborators

University of Washington

Investigators

  • Study Director: Marcia A Ciol, PhD, University of Washington
  • Study Director: Paula Elaine D Reis, RN PhD, University of Brasilia

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2014

Primary Completion (ACTUAL)

March 1, 2015

Study Completion (ACTUAL)

November 1, 2015

Study Registration Dates

First Submitted

September 20, 2014

First Submitted That Met QC Criteria

September 23, 2014

First Posted (ESTIMATE)

September 26, 2014

Study Record Updates

Last Update Posted (ESTIMATE)

December 2, 2015

Last Update Submitted That Met QC Criteria

November 30, 2015

Last Verified

November 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • DRCradiodermatitis

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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