Use of Chamomilla Recutita in Mucositis

Mucositis Clinical Trial

Official title:

Chamomilla Recutita Use of Oral Mucositis in Patients Undergoing Hematopoietic Stem Cell Transplantation

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01341054
• Other study ID #: uspchamomilla01
• Status: Completed
• Phase: N/A
• Start date: January 2011
• Est. completion date: August 2011

Study information

• Verified date: May 2023
• Source: University of Sao Paulo
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: August 2011
• Est. primary completion date: August 2011
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Mucositis

Intervention

Other:
• 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.
• 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.

Locations

Country	Name	City	State
Brazil	Hospital Amaral Carvalho	Jau	São Paulo

Sponsors (1)

Lead Sponsor	Collaborator
University of Sao Paulo

Country where clinical trial is conducted

Brazil, 

References & Publications (1)

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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

External Links

•   PubMed