Use of Chamomilla Recutita in Mucositis

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Fernanda Titareli Merizio Martins Braga, University of Sao Paulo
ClinicalTrials.gov Identifier:
NCT01341054
First received: April 19, 2011
Last updated: January 11, 2013
Last verified: January 2013
  Purpose

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


Condition Intervention Phase
Mucositis
Other: mouthwash with Chamomilla
Other: Standard oral care protocol
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Chamomilla Recutita Use of Oral Mucositis in Patients Undergoing Hematopoietic Stem Cell Transplantation

Resource links provided by NLM:


Further study details as provided by University of Sao Paulo:

Primary Outcome Measures:
  • Oral mucositis intensity [ Time Frame: The measurement will be held on the first day of the conditioning regimen to bone marrow grafting. In an expected average of 4 weeks ] [ Designated as safety issue: No ]

Enrollment: 40
Study Start Date: January 2011
Study Completion Date: August 2011
Primary Completion Date: August 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01341054

Locations
Brazil
Hospital Amaral Carvalho
Jau, São Paulo, Brazil, 17210080
Sponsors and Collaborators
University of Sao Paulo
Investigators
Principal Investigator: Fernanda TM Braga, RN University of Sao Paulo
Study Director: Emilia C Carvalho University of São Paulo
  More Information

No publications provided

Responsible Party: Fernanda Titareli Merizio Martins Braga, PhD, University of Sao Paulo
ClinicalTrials.gov Identifier: NCT01341054     History of Changes
Other Study ID Numbers: uspchamomilla01
Study First Received: April 19, 2011
Last Updated: January 11, 2013
Health Authority: Brazil: National Committee of Ethics in Research

Keywords provided by University of Sao Paulo:
mucositis
chamomilla
therapeutics

Additional relevant MeSH terms:
Mucositis
Gastroenteritis
Gastrointestinal Diseases
Digestive System Diseases
Mouth Diseases
Stomatognathic Diseases

ClinicalTrials.gov processed this record on September 16, 2014