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NCT Number: NCT02247830

Management Radiodermatitis in Patients With Breast or Head and Neck Cancer

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).

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Key information

Conditions

Radiodermatitis Breast Diseases Breast Neoplasms Dermatitis Head and Neck Neoplasms Neoplasms Neoplasms by Site Radiation Injuries Skin Diseases Skin and Connective Tissue Diseases Wounds and Injuries

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

University Hospital of Brasília

Brasília, Brazil

About this study

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).

Who can participate

Healthy volunteers accepted: Yes

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 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.

Treatment and study plan

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).

Other names: matricaria gel, chamomilla gel, chamomile 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).

Other names: Urea cream based

Primary outcomes

Occurrence of radiodermatitis

Time frame: 5 weeks

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

Sponsors and collaborators

Lead sponsor

University of Brasilia

Other

Registry information

Official study title

Prophylactic Interventions in the Management of Radiodermatitis in Patients With Breast or Head and Neck Cancer: a Randomized Clinical Trial

Acronym: PRBHNC

Important dates

Study start: 2015
Primary completion: 2017
Study completion: 2017
First posted: Sep 25, 2014
Registry last updated: Oct 8, 2020

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.

Published trials that share one or more normalized conditions with this study.

Completed