Clinical trial NCT02247830: Management Radiodermatitis in Patients With Breast or Head and Neck Cancer
Official title: Prophylactic Interventions in the Management of Radiodermatitis in Patients With Breast or Head and Neck Cancer: a Randomized Clinical Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Radiodermatitis
Keywords: Radiodermatitis
Head and neck neoplasms
Radiotherapy
Urea
Matricaria
Breast Neoplasms
chamomilla
chamomile
Lead sponsor: University of Brasilia
Sponsor class: OTHER
First posted: 2014-09-25
Enrollment: 48
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Primary purpose: PREVENTION

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).

Eligibility 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.

Primary outcomes:
measure: Occurrence of radiodermatitis
timeFrame: 5 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Brasilia
country: Brazil
facility: University Hospital of Brasília
Study officials:
affiliation: University of Brasilia
name: Elaine Barros Ferreira, RN
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Brasilia
name: Paula Elaine Diniz dos Reis, RN, PhD
role: STUDY_DIRECTOR
affiliation: University of Washington
name: Marcia A Ciol, PhD
role: STUDY_DIRECTOR
References: