Management Radiodermatitis in Patients With Breast or Head and Neck Cancer

NCT02247830 | Completed Phase 3

• 1 other identifier: radiodermatite01
• Study Type: interventional
• Target: 48
• Locations: 1 country
• Sites: 1

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).

Conditions

Radiodermatitis

Keywords

Radiodermatitis; Head and neck neoplasms; Radiotherapy; Urea; Matricaria; Breast Neoplasms; chamomilla; chamomile

Outcome Measures

Primary Outcomes (1)

• Occurrence of radiodermatitis

  Time of occurrence of radiodermatitis second dose of radiation (or its absence during radiotherapy).

  5 weeks

Study Arms (3)

1 Chamomilla recutita gel

EXPERIMENTAL

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

2 Urea cream

EXPERIMENTAL

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

Control Group (Usual Care)

NO INTERVENTION

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.

Interventions

Chamomilla recutita gel OTHER

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).

Also known as: matricaria gel, chamomilla gel, chamomile gel

1 Chamomilla recutita gel

Urea cream DRUG

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).

Also known as: Urea cream based

2 Urea cream

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Brasilia: lead

Study Sites (1)

University Hospital of Brasília

Brasília, Brazil

Location

MeSH Terms

Conditions

Radiodermatitis; Head and Neck Neoplasms; Breast Neoplasms

Condition Hierarchy (Ancestors)

Dermatitis; Skin Diseases; Skin and Connective Tissue Diseases; Radiation Injuries; Wounds and Injuries; Neoplasms by Site; Neoplasms; Breast Diseases

Study Officials

• Elaine Barros Ferreira, RN

  University of Brasilia

  PRINCIPAL INVESTIGATOR

• Paula Elaine Diniz dos Reis, RN, PhD

  University of Brasilia

  STUDY DIRECTOR

• Marcia A Ciol, PhD

  University of Washington

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: FACTORIAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Nurse

Study Record Dates

• First Submitted: September 19, 2014
• First Posted: September 25, 2014
• Study Start: July 1, 2015
• Primary Completion: May 1, 2017
• Study Completion: July 1, 2017
• Last Updated: October 8, 2020

Record last verified: 2020-10

Locations

BR (1)