NCT02249884

Brief Summary

Dose response curve to define the security and tolerable dose to be used for prevention and treatment of radiodermatitis in patients with breast or head and neck cancer.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
30

participants targeted

Target at P25-P50 for phase_2

Timeline
Completed

Started Feb 2014

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2014

Completed
8 months until next milestone

First Submitted

Initial submission to the registry

September 20, 2014

Completed
6 days until next milestone

First Posted

Study publicly available on registry

September 26, 2014

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2015

Completed
8 months until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2015

Completed
Last Updated

December 2, 2015

Status Verified

November 1, 2015

Enrollment Period

1.1 years

First QC Date

September 20, 2014

Last Update Submit

November 30, 2015

Conditions

Radiodermatitis

Keywords

radiodermatitishead and neck neoplasmsBreast NeoplasmsUreaMatricariachamomillachamomile

Outcome Measures

Primary Outcomes (1)

  • Time of occurrence of Radiodermatitis

    Time of occurrence of Radiodermatitis according with the Radiation Therapy Oncology Group (RTOG).

    3 weeks

Secondary Outcomes (1)

  • Indicators of toxicity

    3 weeks

Study Arms (6)

Urea Dose A

EXPERIMENTAL

Topical application of the urea cream in concentration A. The product should be applied on the skin three times daily over 3 weeks.

Drug: Urea Dose A

Urea Dose B

EXPERIMENTAL

Topical application of the urea cream in concentration B. The product should be applied on the skin three times daily over 3 weeks.

Drug: Urea Dose B

Urea Dose C

EXPERIMENTAL

Topical application of the urea cream in concentration C. The product should be applied on the skin three times daily over 3 weeks.

Drug: Urea Dose C

Chamomile Dose A

EXPERIMENTAL

Topical application of chamomile recutita gel in concentration A. The product should be applied on the skin three times daily over 3 weeks.

Drug: Chamomile Dose A

Chamomile Dose B

EXPERIMENTAL

Topical application of chamomile recutita gel in concentration B. The product should be applied on the skin three times daily over 3 weeks.

Drug: Chamomile Dose B

Chamomile Dose C

EXPERIMENTAL

Topical application of chamomile recutita gel in concentration C. The product should be applied on the skin three times daily over 3 weeks.

Drug: Chamomile Dose C

Interventions

Urea Dose ADRUG

Urea cream for topical use.

Also known as: Urea cream
Urea Dose A
Urea Dose BDRUG

Urea cream for topical use.

Also known as: Urea cream
Urea Dose B
Urea Dose CDRUG

Urea cream for topical use.

Also known as: Urea cream.
Urea Dose C
Chamomile Dose ADRUG

Chamomile gel for topical use.

Also known as: Chamomile gel
Chamomile Dose A
Chamomile Dose BDRUG

Chamomile gel for topical use.

Also known as: Chamomile gel
Chamomile Dose B
Chamomile Dose CDRUG

Chamomile gel for topical use.

Also known as: Chamomile gel
Chamomile Dose C

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (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
  • Have absence of radiodermatitis and integrates skin to start radiotherapy
  • Not have presented anticipated reaction of hypersensitivity to chamomile or any plant of the family Asteraceae or Compositae or urea.
  • Demonstrate conditions to continue the intervention in their home environment when needed.

You may not qualify if:

  • Medical prescription for the procedure of data collection, some kind of intervention to prevent radiodermatitis.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University Hospital of Brasília

Brasília, Federal District, Brazil

Location

MeSH Terms

Conditions

RadiodermatitisHead and Neck NeoplasmsBreast Neoplasms

Condition Hierarchy (Ancestors)

DermatitisSkin DiseasesSkin and Connective Tissue DiseasesRadiation InjuriesWounds and InjuriesNeoplasms by SiteNeoplasmsBreast Diseases

Study Officials

  • Paula Elaine D Reis, RN PhD

    University of Brasilia

    STUDY DIRECTOR

  • Marcia A Ciol, PhD

    University of Washington

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
RN, University of Brasilia

Study Record Dates

First Submitted

September 20, 2014

First Posted

September 26, 2014

Study Start

February 1, 2014

Primary Completion

March 1, 2015

Study Completion

November 1, 2015

Last Updated

December 2, 2015

Record last verified: 2015-11

Locations

BR(1)