Evaluation of Therapeutic Efficacy in Use of Chamomilla Gel, Chamomilla Infuse and Urea in Radiodermatitis

NCT02251392 | Unknown Phase 3

• 1 other identifier: UBrasilia
• Study Type: interventional
• Target: 100
• Locations: 0 countries
• Sites: N/A

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).

Conditions

Radiodermatitis

Keywords

chamomilla; matricaria; chamomile; chamomila; recutita; Breast Neoplasms; head and neck neoplasms; radiotherapy

Outcome Measures

Primary Outcomes (1)

• Reduction of the severity of radiodermatitis, according to the RTOG score.

  This outcome is going to be evaluated weekly by the analisys of the signs and symptoms of radiodermititis ant the RTOG score

  5 weeks

Secondary Outcomes (3)

• Radiation Dose

  5 weeks

• Radiodermititis Cure

  8 weeks

• Time to reduce the severity of radiodermatitis

  5 weeks

Study Arms (3)

Chamomila recutita Gel

EXPERIMENTAL

Experimental Group 1 - patients will apply the gel since the begging of radiodermatitis, three times a day. The dose is being determined in a Phase II study that is being conducted. Topical application of gel is going to occur concomitantly to the initiation of radiodermatitis and will be follow up until the cure of it.

Other: Chamomila recutita Gel

Chamomila recutita Infuse 2,5%

EXPERIMENTAL

Experimental Group 2 - patients will apply the infuse since the begging of radiodermatitis, three times a day. The dose of 2,5% was determined before in a Phase II study. Radiodermatitis grade and intensity is going to be evaluated. Topical application of the infuse is going to occur concomitantly to the initiation of radiodermatitis and will be follow up until the cure of it.

Other: Chamomila recutita Infuse

Urea cream based

ACTIVE COMPARATOR

Control Group - usual care to treat radiodermatitis, patients will apply the infuse since the begging of radiodermatitis, three times a day. Radiodermatitis grade and intensity is going to be evaluated. Topical application of urea is going to occur concomitantly to the initiation of radiodermatitis and will be follow up until the cure of it.

Drug: Urea cream based

Interventions

Chamomila recutita Gel OTHER

Gel formulated with active principles from Chamomilla recutita which dose is being determined in a dose-response curve

Also known as: Chamomile Gel, Chamomila recutita gel

Chamomila recutita Gel

Chamomila recutita Infuse OTHER

chamomila infuse in a concentration of 2,5% already determined in a dose response curve

Also known as: Chamomile Infuse, Chamomila recutita infuse

Chamomila recutita Infuse 2,5%

Urea cream based DRUG

Urea is already using to treat radiodermatitis when it starts to occur, so it will be the usual care

Also known as: Urea cream

Urea cream based

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• 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 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.

You may not qualify if:

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

Sponsors & Collaborators

• University of Brasilia: lead
• University of Washington: collaborator
• Conselho Nacional de Desenvolvimento Científico e Tecnológico: collaborator

Related Publications (1)

• 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.

  PMID: 21412623 BACKGROUND

MeSH Terms

Conditions

Radiodermatitis; Breast Neoplasms; Head and Neck 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 B Ferreira, Nurse

  University of Brasilia

  PRINCIPAL INVESTIGATOR

• Priscila MS Bontempo, Nurse

  University Hospital of Brasilia

  PRINCIPAL INVESTIGATOR

• Marcia A Ciol, Biostatistcs

  University of Washington

  STUDY DIRECTOR

• Karine RM Silva, Nurse

  University of Brasilia

  STUDY CHAIR

• Carlos J Sacramento, Nurse

  University of Brasilia

  STUDY CHAIR

• Paula ED Reis, PhD, Nurse

  University of Brasilia

  STUDY DIRECTOR

• Samuel R Avelino, MP

  University Hospital of Brasilia

  PRINCIPAL INVESTIGATOR

• Leandro X Cardoso, Physics

  University of Brasilia

  STUDY CHAIR

• Luis FO Silva, MP

  University Hospital of Brasilia

  STUDY CHAIR

Study Design

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

Study Record Dates

• First Submitted: September 25, 2014
• First Posted: September 29, 2014
• Study Start: August 1, 2015
• Primary Completion: July 1, 2016
• Study Completion: December 1, 2016
• Last Updated: December 2, 2015

Record last verified: 2015-11