Neoplasms

Skin and Connective Tissue Diseases

All Conditions

Wounds and Injuries

Breast Neoplasms

Head and Neck Neoplasms

Radiodermatitis

Dermatitis

Skin Diseases

Radiation Injuries

Anti-Infective Agents

All Drugs and Chemicals

Herbal and Botanical

Carbamide Peroxide

Anti-Infective Agents, Local

Chamomile

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

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

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

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

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

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

Urea Dose A

Urea Dose B

Urea Dose C

Chamomile Dose A

Chamomile Dose B

Chamomile Dose C

Paula Elaine D Reis, RN PhD

Marcia A Ciol, PhD

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.

The study is being conducted in Center for High Complexity Oncology (CACON) located at the University Hospital of Brasília (HUB). Has as its target population subjects diagnosed with breast and head and neck cancer undergoing radiotherapy. Three doses of urea cream are being tested. Participants are subjected to simple randomization technique, in which the members of the study are directly allocated in groups set forth, without any intermediate step. Patients are identified, go to a nursing consultation for general orientations about treatment. After the consultation, patients are invited to participate in the study. The patient should express its acceptance through the informed consent form. Data are being collected through interviews and medical records. Patients are being evaluated during three weeks, considering the toxicity of the intervention and the beginning of radiodermatitis. 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). For reliable assessment and record of the evolution throughout the treatment and study, patients will be photographed weekly (D0, D5, D10, D15). Will be photographed major regions subject to evaluation: frontal, right side profile and left side profile with Photographic camera Nikon P510. The data will be inserted into Statistical Package for Social Sciences (SPSS), version 18.0, for the analysis.

Dose-Response Curve: Interventions to Prevent and Treat Radiodermatitis

Use of Chamomilla Recutita Gel and Urea Cream to Prevent and Treat Radiodermatitis: Phase 2 Study

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

Evaluate the tolerance and safety of the intervention according to the assessment of toxicity during the intervention.

To evaluate the toxicity will be considered signs and symptoms referable to the region of application of the product, such as skin rash, urticaria, vesicles, blisters, pustules, as well as the patient's report of discomfort, burning, stinging and itching.

University of Washington

University of Brasilia

RN, University of Brasilia

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.

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.

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.

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

Chamomila recutita Gel

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

Chamomila recutita Infuse

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

Urea cream based

Elaine B Ferreira, Nurse

Priscila MS Bontempo, Nurse

Marcia A Ciol, Biostatistcs

Karine RM Silva, Nurse

Carlos J Sacramento, Nurse

Paula ED Reis, PhD, Nurse

Samuel R Avelino, MP

Leandro X Cardoso, Physics

Luis FO Silva, MP

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).

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.

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

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

The time that pacient don´t have more the radiodermititis

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

Conselho Nacional de Desenvolvimento Científico e Tecnológico

PROFESSOR

Pharmaceutical Solutions

Experimental Group 01: usual care + topical application of the gel recutita chamomile. Such intervention will be characterized by topical application of the gel C. recutita, concomitantly to the initiation of radiotherapy, should be applied on the irradiated three times daily throughout the period of realization of radiotherapy sessions area, and nursing consultations with equipment instructional (usual care).

Experimental Group 02: usual care + Topical Application of Urea cream. The intervention will be characterized by topical application of urea-based cream on the area irradiated three times daily throughout the period of realization of radiotherapy sessions, in addition to nursing consultation with instructional material (usual care).

The usual care consists of nursing consultation with instructional material (Manual guidelines) that is already done systematically in service. This query is made with all patients starting radiotherapy. Here, guidelines are provided about skin care and hydration, using topical moisturizing soap solution over the bath. Such information is contained in the manual that is provided to the patient during the consultation.

Such intervention will be characterized by topical application of C. recutita gel, concomitantly to the initiation of radiotherapy, should be applied on the irradiated region three times daily throughout the period of realization of radiotherapy sessions area, and nursing consultations with equipment instructional (usual care).

Chamomilla recutita gel

Experimental Group 02: usual care + Topical Application of Urea cream. The intervention will be characterized by topical application of urea-based cream on the irradiated region three times daily throughout the period of realization of radiotherapy sessions, in addition to nursing consultation with instructional material (usual care).

Urea cream

Elaine Barros Ferreira, RN

Paula Elaine Diniz dos Reis, RN, PhD

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).

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).

Management Radiodermatitis in Patients With Breast or Head and Neck Cancer

Prophylactic Interventions in the Management of Radiodermatitis in Patients With Breast or Head and Neck Cancer: a Randomized Clinical Trial

Time of occurrence of radiodermatitis second dose of radiation (or its absence during radiotherapy).

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Dose-Response Curve: Interventions to Prevent and Treat Radiodermatitis	NCT02249884	Radiodermatitis	Urea Dose A Urea Dose B Urea Dose C Chamomile Dose ... Chamomile Dose ... Chamomile Dose ...	18 Years -	University of Brasilia
Evaluation of Therapeutic Efficacy in Use of Chamomilla Gel, Chamomilla Infuse and Urea in Radiodermatitis	NCT02251392	Radiodermatitis	Chamomila recut... Chamomila recut... Urea cream base...	18 Years -	University of Brasilia
Evaluation of Therapeutic Efficacy in Use of Chamomilla Gel, Chamomilla Infuse and Urea in Radiodermatitis	NCT02251392	Radiodermatitis	Chamomila recut... Chamomila recut... Urea cream base...	18 Years -	University of Brasilia
Management Radiodermatitis in Patients With Breast or Head and Neck Cancer	NCT02247830	Radiodermatitis	Chamomilla recu... Urea cream	18 Years -	University of Brasilia
Management Radiodermatitis in Patients With Breast or Head and Neck Cancer	NCT02247830	Radiodermatitis	Chamomilla recu... Urea cream	18 Years -	University of Brasilia

Spots Global Cancer Trial Database for chamomilla

Every month we try and update this database with for chamomilla cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Spots Global Cancer Trial Database for chamomilla

Every month we try and update this database with for chamomilla cancer trials from around the world to help patients and their families find trials that might be right for them. We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Every month we try and update this database with for chamomilla cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.