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Dose-Response Curve: Interventions to Prevent and Treat Radiodermatitis

NCT ID: NCT02249884

Last Updated: 2015-12-02

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-02-28

Study Completion Date

2015-11-30

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Radiodermatitis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Study Groups

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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.

Group Type EXPERIMENTAL

Urea Dose A

Intervention Type DRUG

Urea cream for topical use.

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.

Group Type EXPERIMENTAL

Urea Dose B

Intervention Type DRUG

Urea cream for topical use.

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.

Group Type EXPERIMENTAL

Urea Dose C

Intervention Type DRUG

Urea cream for topical use.

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.

Group Type EXPERIMENTAL

Chamomile Dose A

Intervention Type DRUG

Chamomile gel for topical use.

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.

Group Type EXPERIMENTAL

Chamomile Dose B

Intervention Type DRUG

Chamomile gel for topical use.

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.

Group Type EXPERIMENTAL

Chamomile Dose C

Intervention Type DRUG

Chamomile gel for topical use.

Interventions

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Urea Dose A

Urea cream for topical use.

Intervention Type DRUG

Urea Dose B

Urea cream for topical use.

Intervention Type DRUG

Urea Dose C

Urea cream for topical use.

Intervention Type DRUG

Chamomile Dose A

Chamomile gel for topical use.

Intervention Type DRUG

Chamomile Dose B

Chamomile gel for topical use.

Intervention Type DRUG

Chamomile Dose C

Chamomile gel for topical use.

Intervention Type DRUG

Other Intervention Names

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Urea cream Urea cream Urea cream. Chamomile gel Chamomile gel Chamomile gel

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of Washington

OTHER

Sponsor Role collaborator

University of Brasilia

OTHER

Sponsor Role lead

Responsible Party

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Elaine Barros Ferreira

RN, University of Brasilia

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Paula Elaine D Reis, RN PhD

Role: STUDY_DIRECTOR

University of Brasilia

Marcia A Ciol, PhD

Role: STUDY_DIRECTOR

University of Washington

Locations

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University Hospital of Brasília

Brasília, Federal District, Brazil

Site Status

Countries

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Brazil

Other Identifiers

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DRCradiodermatitis

Identifier Type: -

Identifier Source: org_study_id