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Management Radiodermatitis in Patients With Breast or Head and Neck Cancer (PRBHNC)

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ClinicalTrials.gov Identifier: NCT02247830
Recruitment Status : Active, not recruiting
First Posted : September 25, 2014
Last Update Posted : April 18, 2019
Sponsor:
Information provided by (Responsible Party):
Elaine Barros Ferreira, University of Brasilia

Brief Summary:

It aims to evaluate the efficacy of the chamomile recutita gel and urea cream in the prevention of radiodermatitis in patients with breast cancer or head and neck cancer undergoing radiotherapy.

Prophylactic Trial will consist of a control group and two experimental groups, namely control group (usual care), Experimental Group 01 (usual care + topical application of the gel C. recutita) and Experimental Group 02 (usual care + topical application of Urea based cream).

The doses used in the different compounds are being in test since february 2014 by a dose-response curve study, using 6 groups with three doses of urea cream and three doses of C. recutita gel.

The study will be conducted at the Center for High Complexity Oncology at University Hospital of Brasília (CACON/HUB), Brazil. The degree of radiodermatitis is evaluated weekly, according to established criteria to classify the effects of radiotherapy, which identifies grades 0, 1, 2 , 3 and 4, according to the score of the Radiation Therapy Oncology Group - RTOG. To evaluate the skin reaction will also be applied scale Common Terminology Criteria for Adverse Events (CTCAE) and Radiation-Induced Skin Reaction Assessment Scale (RISRAS).


Condition or disease Intervention/treatment Phase
Radiodermatitis Other: Chamomilla recutita gel Drug: Urea cream Phase 3

Detailed Description:

It is considered that patients undergoing radiotherapy in use gel based on C. recutita or use of cream based urea three times a day, concomitant radiotherapy, would present the following hypotheses:

  • Null: equal incidence and severity of radiodermatitis when compared to the control group (usual care);
  • Alternative 1: low incidence and severity of radiodermatitis when compared to patients who comprised the control group (usual care).
  • Alternative 2: lower incidence and severity of radiodermatitis between the experimental groups (urea and chamomile).

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Prophylactic Interventions in the Management of Radiodermatitis in Patients With Breast or Head and Neck Cancer: a Randomized Clinical Trial
Study Start Date : July 2016
Estimated Primary Completion Date : December 2019
Estimated Study Completion Date : January 2020

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: 1 Chamomilla recutita gel
Experimental Group 01: usual care + topical application of the gel recutita chamomile. Such intervention will be characterized by topical application of the gel C. recutita, concomitantly to the initiation of radiotherapy, should be applied on the irradiated three times daily throughout the period of realization of radiotherapy sessions area, and nursing consultations with equipment instructional (usual care).
Other: Chamomilla recutita gel
Such intervention will be characterized by topical application of C. recutita gel, concomitantly to the initiation of radiotherapy, should be applied on the irradiated region three times daily throughout the period of realization of radiotherapy sessions area, and nursing consultations with equipment instructional (usual care).
Other Names:
  • matricaria gel
  • chamomilla gel
  • chamomile gel

Experimental: 2 Urea cream
Experimental Group 02: usual care + Topical Application of Urea cream. The intervention will be characterized by topical application of urea-based cream on the area irradiated three times daily throughout the period of realization of radiotherapy sessions, in addition to nursing consultation with instructional material (usual care).
Drug: Urea cream
Experimental Group 02: usual care + Topical Application of Urea cream. The intervention will be characterized by topical application of urea-based cream on the irradiated region three times daily throughout the period of realization of radiotherapy sessions, in addition to nursing consultation with instructional material (usual care).
Other Name: Urea cream based

No Intervention: Control Group (Usual Care)
The usual care consists of nursing consultation with instructional material (Manual guidelines) that is already done systematically in service. This query is made with all patients starting radiotherapy. Here, guidelines are provided about skin care and hydration, using topical moisturizing soap solution over the bath. Such information is contained in the manual that is provided to the patient during the consultation.



Primary Outcome Measures :
  1. Occurrence of radiodermatitis [ Time Frame: 5 weeks ]
    Time of occurrence of radiodermatitis second dose of radiation (or its absence during radiotherapy).



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Being an adult, over the age of 18 years old;
  • Owning diagnosis of malignant breast or head and neck;
  • Being first referred to the radiotherapy protocol;
  • Agree to participate, expressing his acceptance by signing the Informed Consent Form (ICF);
  • Present absence of dermatitis to initiation of radiotherapy;
  • Demonstrate understanding of and conditions to continue the intervention in their home environment when needed.

Exclusion Criteria:

  • Reports of previous hypersensitivity reaction or presentation, during the research, adverse reaction to chamomile or any plant of the Asteraceae or compositae family, or urea;
  • Medical prescription for the procedure of data collection, some kind of intervention to prevent radiodermatitis;
  • Withdrawal of the patient to remain in the study, independent of time.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02247830


Locations
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Brazil
University Hospital of Brasília
Brasilia, Brazil
Sponsors and Collaborators
University of Brasilia
Investigators
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Principal Investigator: Elaine Barros Ferreira, RN University of Brasilia
Study Director: Paula Elaine Diniz dos Reis, RN, PhD University of Brasilia
Study Director: Marcia A Ciol, PhD University of Washington

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Responsible Party: Elaine Barros Ferreira, Nurse, University of Brasilia
ClinicalTrials.gov Identifier: NCT02247830     History of Changes
Other Study ID Numbers: radiodermatite01
First Posted: September 25, 2014    Key Record Dates
Last Update Posted: April 18, 2019
Last Verified: April 2019
Keywords provided by Elaine Barros Ferreira, University of Brasilia:
Radiodermatitis
Head and neck neoplasms
Radiotherapy
Urea
Matricaria
Breast Neoplasms
chamomilla
chamomile
Additional relevant MeSH terms:
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Head and Neck Neoplasms
Radiodermatitis
Neoplasms by Site
Neoplasms
Dermatitis
Skin Diseases
Radiation Injuries
Wounds and Injuries