Clinical trial NCT02251392: Evaluation of Therapeutic Efficacy in Use of Chamomilla Gel, Chamomilla Infuse and Urea in Radiodermatitis
Official title: Evaluation of Therapeutic Efficacy in Use of Chamomila Gel, Chamomila Infuse and Urea in Patients With Breast or Head and Neck Cancer That Developed Radiodermatitis
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE3
Conditions: Radiodermatitis
Keywords: chamomilla
matricaria
chamomile
chamomila
recutita
Breast Neoplasms
head and neck neoplasms
radiotherapy
Lead sponsor: University of Brasilia
Sponsor class: OTHER
Collaborators: name: University of Washington
name: Conselho Nacional de Desenvolvimento Científico e Tecnológico
First posted: 2014-09-29
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study aims to evaluate therapeutics interventions in radiodermatitis in patients with breast or head and neck cancer. The data collect is going to begin after determining the better dose in a dose-response curve that is being conduct now in the same institution. To evaluate the skin reaction will be applied scale of the Radiation Therapy Oncology Group (RTOG) - Acute Radiation Morbidity Scoring Criteria, Common Terminology Criteria for Adverse Events (CTCAE) and Radiation-Induced Skin Reaction Assessment Scale (RISRAS).

Detailed description: Hypothesis:

Chamomila gel is more effective than urea (usual care); Chamomila infuse is more effective than urea (usual care); Chamomila gel is more effective than chamomila infuse; Chamomila infuse is more effective than chamomila gel; Chamomila gel is as effective than urea (usual care); Chamomila infuse is as effective than urea (usual care); Chamomila gel is as effective than chamomila infuse; Chamomila infuse is as effective than chamomila gel.

Eligibility criteria: Inclusion Criteria:

Being an adult, over the age of 18 years old; Owning diagnosis of breast or head and neck cancer; Being first referred to the radiotherapy protocol; Presenting radiodermatitis grades 1 or 2, second RTOG score, in the place where is receiving radiation therapy; No history of previous hypersensitivity reaction to chamomile or any plant of the Asteraceae or Compositae family or Urea; Demonstrate understanding to continue the intervention in their home environment when necessary.

Exclusion Criteria:

Medical prescription, during the process of data collection, some kind of intervention to prevent radiodermatitis

Primary outcomes:
measure: Reduction of the severity of radiodermatitis, according to the RTOG score.
timeFrame: 5 weeks
Secondary outcomes:
measure: Radiation Dose
timeFrame: 5 weeks
measure: Radiodermititis Cure
timeFrame: 8 weeks
measure: Time to reduce the severity of radiodermatitis
timeFrame: 5 weeks
Other outcomes:
Locations:
Study officials:
affiliation: University of Brasilia
name: Elaine B Ferreira, Nurse
role: PRINCIPAL_INVESTIGATOR
affiliation: University Hospital of Brasilia
name: Priscila MS Bontempo, Nurse
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Washington
name: Marcia A Ciol, Biostatistcs
role: STUDY_DIRECTOR
affiliation: University of Brasilia
name: Karine RM Silva, Nurse
role: STUDY_CHAIR
affiliation: University of Brasilia
name: Carlos J Sacramento, Nurse
role: STUDY_CHAIR
affiliation: University of Brasilia
name: Paula ED Reis, PhD, Nurse
role: STUDY_DIRECTOR
affiliation: University Hospital of Brasilia
name: Samuel R Avelino, MP
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Brasilia
name: Leandro X Cardoso, Physics
role: STUDY_CHAIR
affiliation: University Hospital of Brasilia
name: Luis FO Silva, MP
role: STUDY_CHAIR
References:
citation: Reis PE, Carvalho EC, Bueno PC, Bastos JK. Clinical application of Chamomilla recutita in phlebitis: dose response curve study. Rev Lat Am Enfermagem. 2011 Jan-Feb;19(1):3-10. doi: 10.1590/s0104-11692011000100002.