Mucositis
Conditions
Keywords
mucositis, chamomilla, therapeutics
Brief 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.
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.
Interventions
OTHERmouthwash with Chamomilla
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.
OTHERStandard oral care protocol
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.
Sponsors
University of Sao Paulo
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* subjects over 18 years of age; * candidates for allogeneic HSCT; * with intact oral cavity on the first day of conditioning.
Exclusion criteria
* 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.
Design outcomes
Primary
| Measure | 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 |
Countries
Brazil
Outcome results
None listed