Use of Chamomilla Recutita in Mucositis

Not Applicable

Completed

• Conditions: Mucositis
• Interventions: Other: mouthwash with Chamomilla; Other: Standard oral care protocol

• Registration Number: NCT01341054
• Lead Sponsor: University of Sao Paulo

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.

Study Timeline

• Study Start: 2011-01
• Study First Submitted: 2011-04-19
• Study First Submitted QC: 2011-04-21
• Study First Posted: 2011-04-25
• Primary Completion: 2011-08
• Study Completion: 2011-08
• Status Verified: 2023-05
• Last Update Submitted: 2023-05-11
• Last Update Posted: 2023-05-15

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 40

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
mouthwash with Chamomilla extract 1%	mouthwash with Chamomilla	The Chamomile recutita mouthwash 1% was administered two times daily for 30 days.
standard oral care protocol	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.
mouthwash with Chamomilla extract 2%	mouthwash with Chamomilla	The Chamomile recutita mouthwash 2% was administered two times daily for 30 days.
mouthwash with Chamomilla extract 0.5%	mouthwash with Chamomilla	The Chamomile recutita mouthwash 0.5% was administered two times daily for 30 days, starting on the first day of chemotherapy.

Primary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

Hospital Amaral Carvalho; 🇧🇷 Jau, São Paulo, Brazil