Clinical Trial: Use of Chamomilla Recutita in Mucositis

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

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

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 Summary: 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.
Sponsor: University of Sao Paulo

Current Primary Outcome: 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 ]

Original Primary Outcome: 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 30 days ]

Current Secondary Outcome:

Original Secondary Outcome:

Information By: University of Sao Paulo

Dates:
Date Received: April 19, 2011
Date Started: January 2011
Date Completion:
Last Updated: January 11, 2013
Last Verified: January 2013