RadiodermatitisPhase 2DRCPTRNCT02249884
Dose-Response Curve: Interventions to Prevent and Treat Radiodermatitis
A Phase 2 study testing Urea Dose A, Urea Dose B and Urea Dose C in people with Radiodermatitis, run by University of Brasilia at 1 site in Brazil.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Radiodermatitis
- What is being tested?
- Urea Dose A, Urea Dose B and Urea Dose C
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteBrazil
- Study dates
- Feb 2014to Nov 2015
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- Medical prescription for the procedure of data collection, some kind of intervention to prevent radiodermatitis.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Use of Chamomilla Recutita Gel and Urea Cream to Prevent and Treat Radiodermatitis: Phase 2 Study
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.
Read the detailed description
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.
- Conditions
- Radiodermatitis
- Being tested
- Urea Dose A, Urea Dose B, Urea Dose C, Chamomile Dose A, Chamomile Dose B
- Keywords
- radiodermatitis, head and neck neoplasms, Breast Neoplasms, Urea, Matricaria, chamomilla, chamomile
- Medical subject headings
- Radiodermatitis, Head and Neck Neoplasms, Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Urea Dose ADrug
Also called Urea cream
Urea cream for topical use.
Urea Dose BDrug
Also called Urea cream
Urea cream for topical use.
Urea Dose CDrug
Also called Urea cream.
Urea cream for topical use.
Chamomile Dose ADrug
Also called Chamomile gel
Chamomile gel for topical use.
Chamomile Dose BDrug
Also called Chamomile gel
Chamomile gel for topical use.
Chamomile Dose CDrug
Also called Chamomile gel
Chamomile gel for topical use.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: 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. Receives: 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. Receives: 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. Receives: 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. Receives: Drug: Chamomile Dose C |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time of occurrence of Radiodermatitis
Time of occurrence of Radiodermatitis according with the Radiation Therapy Oncology Group (RTOG).
Measured: 3 weeks
Secondary outcomes (1)
Indicators of toxicity
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.
Measured: 3 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Sep 2014 (estimated)
- Study startFeb 2014
- Primary completionMar 2015
- Study completionNov 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for RadiodermatitisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Brasilia
- Sponsor type
- University, hospital or other
- Collaborators
- University of Washington
- Responsible party
- Principal investigator, Elaine Barros Ferreira, University of Brasilia
- Investigators
- Paula Elaine D Reis, RN PhD, Study director, University of BrasiliaMarcia A Ciol, PhD, Study director, University of Washington
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02249884
- Sponsor's protocol ID
- DRCradiodermatitis
- Acronym
- DRCPTR
- Status last verified
- Nov 2015
- First submitted
- 20 Sep 2014
- Last updated
- 2 Dec 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Dec 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Use of Chamomilla Recutita Gel and Urea Cream to Prevent and Treat Radiodermatitis: Phase 2 Study
- ClinicalTrials.gov ID
- NCT02249884
- Acronym / sponsor ID
- DRCPTR / DRCradiodermatitis
- Conditions
- Radiodermatitis
- Keywords
- radiodermatitis, head and neck neoplasms, Breast Neoplasms, Urea, Matricaria, chamomilla, chamomile
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- University of BrasiliaUniversity, hospital or other
- Collaborators
- University of Washington
- Study start
- Feb 2014
- Primary completion
- Mar 2015 (actual)
- Study completion
- Nov 2015 (actual)
- First posted
- 26 Sep 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 6
| Arm | Type | Receives |
|---|---|---|
| Urea Dose A | Experimental | Drug: Urea Dose ATopical application of the urea cream in concentration A. The product should be applied on the skin three times daily over 3 weeks. |
| Urea Dose B | Experimental | Drug: Urea Dose BTopical application of the urea cream in concentration B. The product should be applied on the skin three times daily over 3 weeks. |
| Urea Dose C | Experimental | Drug: Urea Dose CTopical application of the urea cream in concentration C. The product should be applied on the skin three times daily over 3 weeks. |
| Chamomile Dose A | Experimental | Drug: Chamomile Dose ATopical application of chamomile recutita gel in concentration A. The product should be applied on the skin three times daily over 3 weeks. |
| Chamomile Dose B | Experimental | Drug: Chamomile Dose BTopical application of chamomile recutita gel in concentration B. The product should be applied on the skin three times daily over 3 weeks. |
| Chamomile Dose C | Experimental | Drug: Chamomile Dose CTopical application of chamomile recutita gel in concentration C. The product should be applied on the skin three times daily over 3 weeks. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (1 listed)
- Medical prescription for the procedure of data collection, some kind of intervention to prevent radiodermatitis.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Urea Dose AAlso: Urea creamUrea cream for topical use. | Drug | Urea Dose A |
| Urea Dose BAlso: Urea creamUrea cream for topical use. | Drug | Urea Dose B |
| Urea Dose CAlso: Urea cream.Urea cream for topical use. | Drug | Urea Dose C |
| Chamomile Dose AAlso: Chamomile gelChamomile gel for topical use. | Drug | Chamomile Dose A |
| Chamomile Dose BAlso: Chamomile gelChamomile gel for topical use. | Drug | Chamomile Dose B |
| Chamomile Dose CAlso: Chamomile gelChamomile gel for topical use. | Drug | Chamomile Dose C |
Primary outcome
Time of occurrence of Radiodermatitis
Time frame: 3 weeks
Time of occurrence of Radiodermatitis according with the Radiation Therapy Oncology Group (RTOG).
1 secondary outcome
Indicators of toxicity
Time frame: 3 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Dec 2015.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Paula Elaine D Reis, RN PhD study director
University of Brasilia
Marcia A Ciol, PhD study director
University of Washington
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Urea Dose A, Urea Dose B and Urea Dose C in people with Radiodermatitis, run by University of Brasilia at 1 site in Brazil.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 2 Dec 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Brazil. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Time of occurrence of Radiodermatitis (time frame: 3 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Dec 2015.