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

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

Status

UNKNOWN

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02251392

Acronym

ChamomillaTH

Enrollment

100

Registered

2014-09-29

Start date

2015-08-31

Completion date

2016-12-31

Last updated

2015-12-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Radiodermatitis

Keywords

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

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.

Interventions

OTHERChamomila recutita Gel

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

OTHERChamomila recutita Infuse

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

DRUGUrea cream based

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

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

DOUBLE (Subject, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
Reduction of the severity of radiodermatitis, according to the RTOG score.	5 weeks	This outcome is going to be evaluated weekly by the analisys of the signs and symptoms of radiodermititis ant the RTOG score

Secondary

Measure	Time frame	Description
Radiation Dose	5 weeks	radiation total dose and fraction
Radiodermititis Cure	8 weeks	The time that pacient don´t have more the radiodermititis
Time to reduce the severity of radiodermatitis	5 weeks	This outcome is going to be evaluated weekly by the analisys of the time of reduce the signs and symptoms of radiodermititis ant the RTOG score

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026