Use of Chamomilla Recutita in Mucositis

University of Sao Paulo

Status: Completed

Conditions: Mucositis

Treatments: Other: mouthwash with Chamomilla; Other: Standard oral care protocol

Study type: Interventional

Funder types: Other

Identifiers

NCT01341054

uspchamomilla01

Details and patient eligibility

About

To determine the Chamomilla recutita solution dose needed to reduce the intensity and evolution time of oral mucositis in adult subjects submitted to HSCT.

Full 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.

Enrollment: 40 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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40 participants in 4 patient groups

mouthwash with Chamomilla extract 1%

Experimental group

Description:

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

Treatment:

Other: mouthwash with Chamomilla

mouthwash with Chamomilla extract 2%

Experimental group

Description:

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

Treatment:

Other: mouthwash with Chamomilla

standard oral care protocol

Active Comparator group

Description:

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.

Treatment:

Other: Standard oral care protocol

mouthwash with Chamomilla extract 0.5%

Experimental group

Description:

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

Treatment:

Other: mouthwash with Chamomilla