Use of Chamomilla Recutita in Mucositis

NCT01341054 | Completed DMC

• 1 other identifier: uspchamomilla01
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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.

Conditions

Mucositis

Keywords

mucositis; chamomilla; therapeutics

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (4)

mouthwash with Chamomilla extract 1%

EXPERIMENTAL

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

Other: mouthwash with Chamomilla

mouthwash with Chamomilla extract 2%

EXPERIMENTAL

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

Other: mouthwash with Chamomilla

standard oral care protocol

ACTIVE COMPARATOR

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.

Other: Standard oral care protocol

mouthwash with Chamomilla extract 0.5%

EXPERIMENTAL

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

Other: mouthwash with Chamomilla

Interventions

mouthwash with Chamomilla 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 0.5%; mouthwash with Chamomilla extract 1%; mouthwash with Chamomilla extract 2%

Standard oral care protocol 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.

standard oral care protocol

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• subjects over 18 years of age;
• candidates for allogeneic HSCT;
• with intact oral cavity on the first day of conditioning.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Sao Paulo: lead

Study Sites (1)

Hospital Amaral Carvalho

Jaú, São Paulo, 17210080, Brazil

Location

Related 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.

  PMID: 25232958 BACKGROUND

Related Links

• PubMed

MeSH Terms

Conditions

Mucositis

Interventions

Mouthwashes

Condition Hierarchy (Ancestors)

Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Mouth Diseases; Stomatognathic Diseases

Intervention Hierarchy (Ancestors)

Biomedical and Dental Materials; Specialty Uses of Chemicals; Chemical Actions and Uses; Cosmetics; Manufactured Materials; Technology, Industry, and Agriculture

Study Officials

• Fernanda TM Braga, RN

  University of Sao Paulo

  PRINCIPAL INVESTIGATOR

• Emilia C Carvalho

  University of Sao Paulo

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: PhD

Study Record Dates

• First Submitted: April 19, 2011
• First Posted: April 25, 2011
• Study Start: January 1, 2011
• Primary Completion: August 1, 2011
• Study Completion: August 1, 2011
• Last Updated: May 15, 2023

Record last verified: 2023-05

Locations

BR (1)