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To determine the Chamomilla recutita solution dose needed to reduce the intensity and evolution time of oral mucositis in adult subjects submitted to HSCT.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| mouthwash with Chamomilla extract 1% | Experimental | The Chamomile recutita mouthwash 1% was administered two times daily for 30 days. |
|
| mouthwash with Chamomilla extract 2% | Experimental | The Chamomile recutita mouthwash 2% was administered two times daily for 30 days. |
|
| 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. |
|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| mouthwash with Chamomilla | Other | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Oral mucositis intensity | The measurement will be held on the first day of the conditioning regimen to bone marrow grafting. In an expected average of 4 weeks |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Fernanda TM Braga, RN | University of Sao Paulo | Principal Investigator |
| Emilia C Carvalho | University of Sao Paulo | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hospital Amaral Carvalho | Jaú | São Paulo | 17210080 | Brazil |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 25232958 | Background | 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. |
| Label | URL |
|---|---|
| PubMed | View source |
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| ID | Term |
|---|---|
| D052016 | Mucositis |
| ID | Term |
|---|---|
| D005759 | Gastroenteritis |
| D005767 | Gastrointestinal Diseases |
| D004066 | Digestive System Diseases |
| D009059 | Mouth Diseases |
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| ID | Term |
|---|---|
| D009067 | Mouthwashes |
| ID | Term |
|---|---|
| D001697 | Biomedical and Dental Materials |
| D020313 | Specialty Uses of Chemicals |
| D020164 | Chemical Actions and Uses |
| D003358 | Cosmetics |
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| Standard oral care protocol | Other | 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. |
|
| D009057 |
| Stomatognathic Diseases |
| D008420 | Manufactured Materials |
| D013676 | Technology, Industry, and Agriculture |