RadiodermatitisPhase 3PRBHNCNCT02247830
Management Radiodermatitis in Patients With Breast or Head and Neck Cancer
A Phase 3 study testing Chamomilla recutita gel and Urea cream in people with Radiodermatitis, run by University of Brasilia at 1 site in Brazil.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Radiodermatitis
- What is being tested?
- Chamomilla recutita gel and Urea cream
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 48 participants
- Where
- 1 siteBrazil
- Study dates
- Jul 2015to Jul 2017
- Phase
- Phase 3
- 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
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Being an adult, over the age of 18 years old;
- Owning diagnosis of malignant breast or head and neck;
- Being first referred to the radiotherapy protocol;
- Agree to participate, expressing his acceptance by signing the Informed Consent Form (ICF);
- Present absence of dermatitis to initiation of radiotherapy;
- Demonstrate understanding of and conditions to continue the intervention in their home environment when needed.
Who cannot join
- Reports of previous hypersensitivity reaction or presentation, during the research, adverse reaction to chamomile or any plant of the Asteraceae or compositae family, or urea;
- Medical prescription for the procedure of data collection, some kind of intervention to prevent radiodermatitis;
- Withdrawal of the patient to remain in the study, independent of time.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Prophylactic Interventions in the Management of Radiodermatitis in Patients With Breast or Head and Neck Cancer: a Randomized Clinical Trial
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).
Read more
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).
Read the detailed description
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).
- Conditions
- Radiodermatitis
- Being tested
- Chamomilla recutita gel, Urea cream
- Keywords
- Radiodermatitis, Head and neck neoplasms, Radiotherapy, Urea, Matricaria, Breast Neoplasms, 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.
Chamomilla recutita gelOther
Also called matricaria gel, chamomilla gel, chamomile gel
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).
Urea creamDrug
Also called Urea cream based
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).
| Study group | Role | What they receive |
|---|---|---|
| 1 Chamomilla recutita gel | Experimental | 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). Receives: Other: Chamomilla recutita gel |
| 2 Urea cream | Experimental | 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). Receives: Drug: Urea cream |
| Control Group (Usual Care) | No intervention | 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Occurrence of radiodermatitis
Time of occurrence of radiodermatitis second dose of radiation (or its absence during radiotherapy).
Measured: 5 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Sep 2014 (estimated)
- Study startJul 2015
- Primary completionMay 2017
- Study completionJul 2017
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 3
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 48 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Brasilia
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Elaine Barros Ferreira, University of Brasilia
- Investigators
- Elaine Barros Ferreira, RN, Principal investigator, University of BrasiliaPaula Elaine Diniz dos Reis, RN, PhD, Study director, University of BrasiliaMarcia A Ciol, PhD, Study director, University of Washington
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02247830
- Sponsor's protocol ID
- radiodermatite01
- Acronym
- PRBHNC
- Status last verified
- Oct 2020
- First submitted
- 19 Sep 2014
- Last updated
- 8 Oct 2020
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Oct 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prophylactic Interventions in the Management of Radiodermatitis in Patients With Breast or Head and Neck Cancer: a Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT02247830
- Acronym / sponsor ID
- PRBHNC / radiodermatite01
- Conditions
- Radiodermatitis
- Keywords
- Radiodermatitis, Head and neck neoplasms, Radiotherapy, Urea, Matricaria, Breast Neoplasms, chamomilla, chamomile
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 48 participants (actual)
- Lead sponsor
- University of BrasiliaUniversity, hospital or other
- Study start
- Jul 2015 (actual)
- Primary completion
- May 2017 (actual)
- Study completion
- Jul 2017 (actual)
- First posted
- 25 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.
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).
Detailed description
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).
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 1 Chamomilla recutita gel | Experimental | Other: Chamomilla recutita gelExperimental 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). |
| 2 Urea cream | Experimental | Drug: Urea creamExperimental 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). |
| Control Group (Usual Care) | No intervention | –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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Being an adult, over the age of 18 years old;
- Owning diagnosis of malignant breast or head and neck;
- Being first referred to the radiotherapy protocol;
- Agree to participate, expressing his acceptance by signing the Informed Consent Form (ICF);
- Present absence of dermatitis to initiation of radiotherapy;
Key exclusion criteria (3 listed)
- Reports of previous hypersensitivity reaction or presentation, during the research, adverse reaction to chamomile or any plant of the Asteraceae or compositae family, or urea;
- Medical prescription for the procedure of data collection, some kind of intervention to prevent radiodermatitis;
- Withdrawal of the patient to remain in the study, independent of time.
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 |
|---|---|---|
| Chamomilla recutita gelAlso: matricaria gel, chamomilla gel, chamomile gelSuch 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). | Other | 1 Chamomilla recutita gel |
| Urea creamAlso: Urea cream basedExperimental 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). | Drug | 2 Urea cream |
Primary outcome
Occurrence of radiodermatitis
Time frame: 5 weeks
Time of occurrence of radiodermatitis second dose of radiation (or its absence during radiotherapy).
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 8 Oct 2020.
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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.
Elaine Barros Ferreira, RN principal investigator
University of Brasilia
Paula Elaine Diniz dos 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 3 study testing Chamomilla recutita gel and Urea cream 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 3 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 8 Oct 2020. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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?
Occurrence of radiodermatitis (time frame: 5 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 8 Oct 2020.