Use of Chamomilla Recutita in Mucositis

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-01-31

Study Completion Date

2011-08-31

Brief Summary

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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.

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Detailed Description

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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

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Mucositis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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mouthwash with Chamomilla extract 1%

The Chamomile recutita mouthwash 1% was administered two times daily for 30 days.

Group Type EXPERIMENTAL

mouthwash with Chamomilla

Intervention Type 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.

mouthwash with Chamomilla extract 2%

The Chamomile recutita mouthwash 2% was administered two times daily for 30 days.

Group Type EXPERIMENTAL

mouthwash with Chamomilla

Intervention Type 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.

standard oral care protocol

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.

Group Type ACTIVE_COMPARATOR

Standard oral care protocol

Intervention Type 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.

mouthwash with Chamomilla extract 0.5%

The Chamomile recutita mouthwash 0.5% was administered two times daily for 30 days, starting on the first day of chemotherapy.

Group Type EXPERIMENTAL

mouthwash with Chamomilla

Intervention Type 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.

Interventions

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mouthwash 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.

Intervention Type OTHER

Standard 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.

Intervention Type OTHER

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No