MucositisNCT01341054
Use of Chamomilla Recutita in Mucositis
A study testing mouthwash with Chamomilla and Standard oral care protocol in people with Mucositis, run by University of Sao Paulo at 1 site in Brazil.
Trial summary
To determine the Chamomilla recutita solution dose needed to reduce the intensity and evolution time of oral mucositis in adult subjects submitted to HSCT. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Mucositis
- What is being tested?
- mouthwash with Chamomilla and Standard oral care protocol
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteBrazil
- Study dates
- Jan 2011to Aug 2011
- Phase
- Interventional
- 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
- subjects over 18 years of age;
- candidates for allogeneic HSCT;
- with intact oral cavity on the first day of conditioning.
Who cannot join
- present any adverse reaction to the active principles of Chamomilla recutita;
- receive oral or intravenous anticoagulation therapy;
- use oral or systemic topical anti-inflammatory medication;
- receive any other type of intervention for mucositis not included in the standard oral care protocol.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Chamomilla Recutita Use of Oral Mucositis in Patients Undergoing Hematopoietic Stem Cell Transplantation
To determine the Chamomilla recutita solution dose needed to reduce the intensity and evolution time of oral mucositis in adult subjects submitted to HSCT.
Read the detailed description
Population: adult subjects, submitted to hematopoietic stem cell transplantation (HSCT) at a cancer hospital in the interior of São Paulo State. The following inclusion criteria were adopted for sample selection purposes: subjects over 18 years of age, candidates for allogeneic HSCT and with intact oral cavity on the first day of conditioning. Subjects will be excluded if they present any adverse reaction to the active principles of Chamomilla recutita; receive oral or intravenous anticoagulation therapy; use oral or systemic topical anti-inflammatory medication; receive any other type of intervention for mucositis not included in the standard oral care protocol.
- Conditions
- Mucositis
- Being tested
- mouthwash with Chamomilla, Standard oral care protocol
- Keywords
- mucositis, chamomilla, therapeutics
- Medical subject headings
- Mucositis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
mouthwash with ChamomillaOther
The Chamomile recutita mouthwash was administered two times daily for 30 days. 10 mL of this solution was swished around in the mouth for approximately one minute and then expectorated.
Standard oral care protocolOther
The standard protocol at the unit, which comprises mouthwash with chlorhexidine 0,12% twice a day; oral hygiene teaching, recommended at least three times per day and always after meals. For brushing, brushes with extra-soft bristles and non-abrasive toothpaste are used. In case the toothbrush cannot be used due to gingival or oral mucosa bleeding, gauze is used to replace it.
| Study group | Role | What they receive |
|---|---|---|
| mouthwash with Chamomilla extract 1% | Experimental | The Chamomile recutita mouthwash 1% was administered two times daily for 30 days. Receives: Other: mouthwash with Chamomilla |
| mouthwash with Chamomilla extract 2% | Experimental | The Chamomile recutita mouthwash 2% was administered two times daily for 30 days. Receives: Other: mouthwash with Chamomilla |
| standard oral care protocol | Active comparator | The standard protocol at the unit, which comprises mouthwash with chlorhexidine 0,12%; oral hygiene teaching. In case the toothbrush cannot be used due to gingival or oral mucosa bleeding, gauze is used to replace it. Receives: Other: Standard oral care protocol |
| mouthwash with Chamomilla extract 0.5% | Experimental | The Chamomile recutita mouthwash 0.5% was administered two times daily for 30 days, starting on the first day of chemotherapy. Receives: Other: mouthwash with Chamomilla |
What is being measured
The primary outcome is the main question the study is designed to answer.
Oral mucositis intensity
Measured: The measurement will be held on the first day of the conditioning regimen to bone marrow grafting. In an expected average of 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Apr 2011 (estimated)
- Study startJan 2011
- Primary completionAug 2011
- Study completionAug 2011
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 MucositisStudies of the same condition, open and under way.
- More trials run by University of Sao PauloThe sponsor's other registered studies.
- 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Sao Paulo
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Fernanda Titareli Merizio Martins Braga, University of Sao Paulo
- Investigators
- Fernanda TM Braga, RN, Principal investigator, University of Sao PauloEmilia C Carvalho, Study director, University of Sao Paulo
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01341054
- Sponsor's protocol ID
- uspchamomilla01
- Status last verified
- May 2023
- First submitted
- 19 Apr 2011
- Last updated
- 15 May 2023
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Braga FT, Santos AC, Bueno PC, Silveira RC, Santos CB, Bastos JK, Carvalho EC. Use of Chamomilla recutita in the Prevention and Treatment of Oral Mucositis in Patients Undergoing Hematopoietic Stem Cell Transplantation: A Randomized, Controlled, Phase II Clinical Trial. Cancer Nurs. 2015 Jul-Aug;38(4):322-9. doi: 10.1097/NCC.0000000000000194.
PubMed 25232958
Study at a glance
From the registry record, last updated by the sponsor on 15 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Chamomilla Recutita Use of Oral Mucositis in Patients Undergoing Hematopoietic Stem Cell Transplantation
- ClinicalTrials.gov ID
- NCT01341054
- Acronym / sponsor ID
- uspchamomilla01
- Conditions
- Mucositis
- Keywords
- mucositis, chamomilla, therapeutics
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- University of Sao PauloUniversity, hospital or other
- Study start
- Jan 2011
- Primary completion
- Aug 2011 (actual)
- Study completion
- Aug 2011 (actual)
- First posted
- 25 Apr 2011 (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.
To determine the Chamomilla recutita solution dose needed to reduce the intensity and evolution time of oral mucositis in adult subjects submitted to HSCT.
Detailed description
Population: adult subjects, submitted to hematopoietic stem cell transplantation (HSCT) at a cancer hospital in the interior of São Paulo State. The following inclusion criteria were adopted for sample selection purposes: subjects over 18 years of age, candidates for allogeneic HSCT and with intact oral cavity on the first day of conditioning. Subjects will be excluded if they present any adverse reaction to the active principles of Chamomilla recutita; receive oral or intravenous anticoagulation therapy; use oral or systemic topical anti-inflammatory medication; receive any other type of intervention for mucositis not included in the standard oral care protocol.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| mouthwash with Chamomilla extract 1% | Experimental | Other: mouthwash with ChamomillaThe Chamomile recutita mouthwash 1% was administered two times daily for 30 days. |
| mouthwash with Chamomilla extract 2% | Experimental | Other: mouthwash with ChamomillaThe Chamomile recutita mouthwash 2% was administered two times daily for 30 days. |
| standard oral care protocol | Active comparator | Other: Standard oral care protocolThe standard protocol at the unit, which comprises mouthwash with chlorhexidine 0,12%; oral hygiene teaching. In case the toothbrush cannot be used due to gingival or oral mucosa bleeding, gauze is used to replace it. |
| mouthwash with Chamomilla extract 0.5% | Experimental | Other: mouthwash with ChamomillaThe Chamomile recutita mouthwash 0.5% was administered two times daily for 30 days, starting on the first day of chemotherapy. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- subjects over 18 years of age;
- candidates for allogeneic HSCT;
- with intact oral cavity on the first day of conditioning.
Key exclusion criteria (4 listed)
- present any adverse reaction to the active principles of Chamomilla recutita;
- receive oral or intravenous anticoagulation therapy;
- use oral or systemic topical anti-inflammatory medication;
- receive any other type of intervention for mucositis not included in the standard oral care protocol.
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 |
|---|---|---|
| mouthwash with ChamomillaThe Chamomile recutita mouthwash was administered two times daily for 30 days. 10 mL of this solution was swished around in the mouth for approximately one minute and then expectorated. | Other | mouthwash with Chamomilla extract 0.5%, mouthwash with Chamomilla extract 1%, mouthwash with Chamomilla extract 2% |
| Standard oral care protocolThe standard protocol at the unit, which comprises mouthwash with chlorhexidine 0,12% twice a day; oral hygiene teaching, recommended at least three times per day and always after meals. For brushing, brushes with extra-soft bristles and non-abrasive toothpaste are used. In case the toothbrush cannot be used due to gingival or oral mucosa bleeding, gauze is used to replace it. | Other | standard oral care protocol |
Primary outcome
Oral mucositis intensity
Time frame: The measurement will be held on the first day of the conditioning regimen to bone marrow grafting. In an expected average of 4 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 15 May 2023.
- Background: PubMed 25232958Braga FT, Santos AC, Bueno PC, Silveira RC, Santos CB, Bastos JK, Carvalho EC. Use of Chamomilla recutita in the Prevention and Treatment of Oral Mucositis in Patients Undergoing Hematopoietic Stem Cell Transplantation: A Randomized, Controlled, Phase II Clinical Trial. Cancer Nurs. 2015 Jul-Aug;38(4):322-9. doi: 10.1097/NCC.0000000000000194.
- PubMedLink provided by the sponsor.
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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.
Fernanda TM Braga, RN principal investigator
University of Sao Paulo
Emilia C Carvalho study director
University of Sao Paulo
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing mouthwash with Chamomilla and Standard oral care protocol in people with Mucositis, run by University of Sao Paulo 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 3 inclusion and 4 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 15 May 2023. 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.
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?
Oral mucositis intensity (time frame: The measurement will be held on the first day of the conditioning regimen to bone marrow grafting. In an expected average of 4 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 NCT01341054, 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 15 May 2023.