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Completed

NCT Number: NCT02249884

Dose-Response Curve: Interventions to Prevent and Treat Radiodermatitis

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

University Hospital of Brasília

Brasília, Federal District, Brazil

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Urea Dose A

Drug

Urea cream for topical use.

Other names: Urea cream

Urea Dose B

Drug

Urea cream for topical use.

Other names: Urea cream

Urea Dose C

Drug

Urea cream for topical use.

Other names: Urea cream.

Chamomile Dose A

Drug

Chamomile gel for topical use.

Other names: Chamomile gel

Chamomile Dose B

Drug

Chamomile gel for topical use.

Other names: Chamomile gel

Chamomile Dose C

Drug

Chamomile gel for topical use.

Other names: Chamomile gel

Primary outcomes

  1. Time of occurrence of Radiodermatitis

    Time frame: 3 weeks

    Time of occurrence of Radiodermatitis according with the Radiation Therapy Oncology Group (RTOG).

Secondary outcomes

  1. 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.

Sponsors and collaborators

Lead sponsor

University of Brasilia

Other

Collaborators

  • University of Washington

Registry information

Official study title

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

Acronym: DRCPTR

Important dates

Study start
2014
Primary completion
2015
Study completion
2015
First posted
Sep 26, 2014
Registry last updated
Dec 2, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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