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Use of Chamomilla Recutita in Mucositis

Primary Purpose

Mucositis

Status
Completed
Phase
Not Applicable
Locations
Brazil
Study Type
Interventional
Intervention
mouthwash with Chamomilla
Standard oral care protocol
Sponsored by
University of Sao Paulo
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Mucositis focused on measuring mucositis, chamomilla, therapeutics

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Hospital Amaral Carvalho

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Experimental

Active Comparator

Experimental

Arm Label

mouthwash with Chamomilla extract 1%

mouthwash with Chamomilla extract 2%

standard oral care protocol

mouthwash with Chamomilla extract 0.5%

Arm Description

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

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

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.

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

Outcomes

Primary Outcome Measures

Oral mucositis intensity

Secondary Outcome Measures

Full Information

First Posted
April 19, 2011
Last Updated
May 11, 2023
Sponsor
University of Sao Paulo
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1. Study Identification

Unique Protocol Identification Number
NCT01341054
Brief Title
Use of Chamomilla Recutita in Mucositis
Official Title
Chamomilla Recutita Use of Oral Mucositis in Patients Undergoing Hematopoietic Stem Cell Transplantation
Study Type
Interventional

2. Study Status

Record Verification Date
May 2023
Overall Recruitment Status
Completed
Study Start Date
January 2011 (undefined)
Primary Completion Date
August 2011 (Actual)
Study Completion Date
August 2011 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Sao Paulo

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Mucositis
Keywords
mucositis, chamomilla, therapeutics

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
40 (Actual)

8. Arms, Groups, and Interventions

Arm Title
mouthwash with Chamomilla extract 1%
Arm Type
Experimental
Arm Description
The Chamomile recutita mouthwash 1% was administered two times daily for 30 days.
Arm Title
mouthwash with Chamomilla extract 2%
Arm Type
Experimental
Arm Description
The Chamomile recutita mouthwash 2% was administered two times daily for 30 days.
Arm Title
standard oral care protocol
Arm Type
Active Comparator
Arm Description
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.
Arm Title
mouthwash with Chamomilla extract 0.5%
Arm Type
Experimental
Arm Description
The Chamomile recutita mouthwash 0.5% was administered two times daily for 30 days, starting on the first day of chemotherapy.
Intervention Type
Other
Intervention Name(s)
mouthwash with Chamomilla
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Standard oral care protocol
Intervention Description
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.
Primary Outcome Measure Information:
Title
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Fernanda TM Braga, RN
Organizational Affiliation
University of Sao Paulo
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Emilia C Carvalho
Organizational Affiliation
University of São Paulo
Official's Role
Study Director
Facility Information:
Facility Name
Hospital Amaral Carvalho
City
Jau
State/Province
São Paulo
ZIP/Postal Code
17210080
Country
Brazil

12. IPD Sharing Statement

Citations:
PubMed Identifier
25232958
Citation
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.
Results Reference
background
Links:
URL
https://www.ncbi.nlm.nih.gov/pubmed/25232958
Description
PubMed

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Use of Chamomilla Recutita in Mucositis

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