RadiodermatitisPhase 3ChamomillaTHNCT02251392
Evaluation of Therapeutic Efficacy in Use of Chamomilla Gel, Chamomilla Infuse and Urea in Radiodermatitis
A Phase 3 study testing Chamomila recutita Gel, Chamomila recutita Infuse and Urea cream based in people with Radiodermatitis, run by University of Brasilia.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Radiodermatitis
- What is being tested?
- Chamomila recutita Gel, Chamomila recutita Infuse and Urea cream based
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- No sites listed yet
- Study dates
- Aug 2015to Dec 2016
- 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
- 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; 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.
Who cannot join
- Medical prescription, during the process of data collection, some kind of intervention to prevent radiodermatitis
About this study
Official title: 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 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).
Read the 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.
- Conditions
- Radiodermatitis
- Being tested
- Chamomila recutita Gel, Chamomila recutita Infuse, Urea cream based
- Keywords
- chamomilla, matricaria, chamomile, chamomila, recutita, Breast Neoplasms, head and neck neoplasms, radiotherapy
- Medical subject headings
- Radiodermatitis, Breast Neoplasms, Head and Neck Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Chamomila recutita GelOther
Also called Chamomile Gel, Chamomila recutita gel
Gel formulated with active principles from Chamomilla recutita which dose is being determined in a dose-response curve
Chamomila recutita InfuseOther
Also called Chamomile Infuse, Chamomila recutita infuse
chamomila infuse in a concentration of 2,5% already determined in a dose response curve
Urea cream basedDrug
Also called Urea cream
Urea is already using to treat radiodermatitis when it starts to occur, so it will be the usual care
| Study group | Role | What they receive |
|---|---|---|
| Chamomila recutita Gel | Experimental | 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. Receives: Other: Chamomila recutita Gel |
| Chamomila recutita Infuse 2,5% | Experimental | 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. Receives: Other: Chamomila recutita Infuse |
| Urea cream based | Active comparator | 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. Receives: Drug: Urea cream based |
What is being measured
The primary outcome is the main question the study is designed to answer.
Reduction of the severity of radiodermatitis, according to the RTOG score.
This outcome is going to be evaluated weekly by the analisys of the signs and symptoms of radiodermititis ant the RTOG score
Measured: 5 weeks
Secondary outcomes (3)
Radiation Dose
radiation total dose and fraction
Measured: 5 weeks
Radiodermititis Cure
The time that pacient don´t have more the radiodermititis
Measured: 8 weeks
Time to reduce the severity of radiodermatitis
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
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 posted29 Sep 2014 (estimated)
- Study startAug 2015
- Primary completionJul 2016 (estimated)
- Study completionDec 2016 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Brasilia
- Sponsor type
- University, hospital or other
- Collaborators
- University of Washington, Conselho Nacional de Desenvolvimento Científico e Tecnológico
- Responsible party
- Principal investigator, PAULA ELAINE DINIZ DOS REIS, University of Brasilia
- Investigators
- Elaine B Ferreira, Nurse, Principal investigator, University of BrasiliaPriscila MS Bontempo, Nurse, Principal investigator, University Hospital of BrasiliaMarcia A Ciol, Biostatistcs, Study director, University of WashingtonKarine RM Silva, Nurse, Study chair, University of BrasiliaCarlos J Sacramento, Nurse, Study chair, University of BrasiliaPaula ED Reis, PhD, Nurse, Study director, University of BrasiliaSamuel R Avelino, MP, Principal investigator, University Hospital of BrasiliaLeandro X Cardoso, Physics, Study chair, University of Brasilia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02251392
- Sponsor's protocol ID
- UBrasilia
- Acronym
- ChamomillaTH
- Status last verified
- Nov 2015
- First submitted
- 25 Sep 2014
- Last updated
- 2 Dec 2015
- Results posted
- No
- Data monitoring committee
- No
Publications
Reis PE, Carvalho EC, Bueno PC, Bastos JK. Clinical application of Chamomilla recutita in phlebitis: dose response curve study. Rev Lat Am Enfermagem. 2011 Jan-Feb;19(1):3-10. doi: 10.1590/s0104-11692011000100002.
PubMed 21412623
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
- 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
- ClinicalTrials.gov ID
- NCT02251392
- Acronym / sponsor ID
- ChamomillaTH / UBrasilia
- Conditions
- Radiodermatitis
- Keywords
- chamomilla, matricaria, chamomile, chamomila, recutita, Breast Neoplasms, head and neck neoplasms, radiotherapy
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- University of BrasiliaUniversity, hospital or other
- Collaborators
- University of Washington, Conselho Nacional de Desenvolvimento Científico e Tecnológico
- Study start
- Aug 2015
- Primary completion
- Jul 2016 (estimated)
- Study completion
- Dec 2016 (estimated)
- First posted
- 29 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.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Chamomila recutita Gel | Experimental | Other: Chamomila recutita GelExperimental 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. |
| Chamomila recutita Infuse 2,5% | Experimental | Other: Chamomila recutita InfuseExperimental 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. |
| Urea cream based | Active comparator | Drug: Urea cream basedControl 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 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; 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.
Key exclusion criteria (1 listed)
- Medical prescription, during the process 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 |
|---|---|---|
| Chamomila recutita GelAlso: Chamomile Gel, Chamomila recutita gelGel formulated with active principles from Chamomilla recutita which dose is being determined in a dose-response curve | Other | Chamomila recutita Gel |
| Chamomila recutita InfuseAlso: Chamomile Infuse, Chamomila recutita infusechamomila infuse in a concentration of 2,5% already determined in a dose response curve | Other | Chamomila recutita Infuse 2,5% |
| Urea cream basedAlso: Urea creamUrea is already using to treat radiodermatitis when it starts to occur, so it will be the usual care | Drug | Urea cream based |
Primary outcome
Reduction of the severity of radiodermatitis, according to the RTOG score.
Time frame: 5 weeks
This outcome is going to be evaluated weekly by the analisys of the signs and symptoms of radiodermititis ant the RTOG score
3 secondary outcomes
Radiation Dose
Time frame: 5 weeks
Radiodermititis Cure
Time frame: 8 weeks
Time to reduce the severity of radiodermatitis
Time frame: 5 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Dec 2015.
- Background: PubMed 21412623Reis PE, Carvalho EC, Bueno PC, Bastos JK. Clinical application of Chamomilla recutita in phlebitis: dose response curve study. Rev Lat Am Enfermagem. 2011 Jan-Feb;19(1):3-10. doi: 10.1590/s0104-11692011000100002.
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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 B Ferreira, Nurse principal investigator
University of Brasilia
Priscila MS Bontempo, Nurse principal investigator
University Hospital of Brasilia
Marcia A Ciol, Biostatistcs study director
University of Washington
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Chamomila recutita Gel, Chamomila recutita Infuse and Urea cream based in people with Radiodermatitis, run by University of Brasilia.
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 1 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: status not confirmed, 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.
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?
Results are not available in the source record.
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?
Reduction of the severity of radiodermatitis, according to the RTOG score. (time frame: 5 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02251392, which also lists 1 linked publication.
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.