Use of Chamomilla Recutita in Mucositis

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

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

Study Overview

• Status: Completed
• Conditions: Mucositis
• Intervention / Treatment: Other: mouthwash with Chamomilla; Other: Standard oral care protocol

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 Type: Interventional
• Enrollment (Actual): 40
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Brazil
  • São Paulo
    • Jau, São Paulo, Brazil, 17210080
      • Hospital Amaral Carvalho

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: mouthwash with Chamomilla extract 1%; The Chamomile recutita mouthwash 1% was administered two times daily for 30 days.	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.
Experimental: mouthwash with Chamomilla extract 2%; The Chamomile recutita mouthwash 2% was administered two times daily for 30 days.	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.
Active Comparator: 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.	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.
Experimental: 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.	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
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

Collaborators and Investigators

• Sponsor: University of Sao Paulo
• Investigators: Principal Investigator: Fernanda TM Braga, RN, University of Sao Paulo; Study Director: Emilia C Carvalho, University of Sao Paulo

Publications and helpful links

General Publications

• 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.

Helpful Links

• PubMed

Study record dates

Study Major Dates

• Study Start: January 1, 2011
• Primary Completion (Actual): August 1, 2011
• Study Completion (Actual): August 1, 2011

Study Registration Dates

• First Submitted: April 19, 2011
• First Submitted That Met QC Criteria: April 21, 2011
• First Posted (Estimate): April 25, 2011

Study Record Updates

• Last Update Posted (Actual): May 15, 2023
• Last Update Submitted That Met QC Criteria: May 11, 2023
• Last Verified: May 1, 2023

More Information

Terms related to this study

• Keywords: mucositis; therapeutics; chamomilla
• Additional Relevant MeSH Terms: Digestive System Diseases; Gastrointestinal Diseases; Gastroenteritis; Stomatognathic Diseases; Mouth Diseases; Mucositis
• Other Study ID Numbers: uspchamomilla01