Management Radiodermatitis in Patients With Breast or Head and Neck Cancer

Phase 3

Completed

• Conditions: Radiodermatitis
• Interventions: Drug: Urea cream; Other: Chamomilla recutita gel

• Registration Number: NCT02247830
• Lead Sponsor: 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).

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).

Study Timeline

• Study First Submitted: 2014-09-19
• Study First Submitted QC: 2014-09-23
• Study First Posted: 2014-09-25
• Study Start: 2015-07
• Primary Completion: 2017-05
• Study Completion: 2017-07
• Status Verified: 2020-10
• Last Update Submitted: 2020-10-07
• Last Update Posted: 2020-10-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 48

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: FACTORIAL

Arm && Interventions

Group	Intervention	Description
2 Urea cream	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).
1 Chamomilla recutita gel	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).

Primary Outcome Measures

Name	Time	Method
Occurrence of radiodermatitis	5 weeks	Time of occurrence of radiodermatitis second dose of radiation (or its absence during radiotherapy).

Trial Locations

Locations (1)

University Hospital of Brasília; 🇧🇷 Brasilia, Brazil