A Pilot Trial to Assess the Effects of Green Tea in the Prevention of Therapy-Induced Mucositis

Mucositis Clinical Trial

Official title:

A Pilot Trial to Assess the Effects of Green Tea in the Prevention of Therapy-Induced Mucositis

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00176514
• Other study ID #: 3074
• Secondary ID: 060001
• Status: Terminated
• Phase: N/A
• First received: September 12, 2005
• Last updated: December 10, 2009
• Start date: July 2000
• Est. completion date: March 2006

Study information

• Verified date: December 2009
• Source: Rutgers, The State University of New Jersey
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

This is a clinical research study that is designed to determine if there is a potential benefit of green tea to help treat and prevent therapy induced mucositis, which is mouth sores caused by chemotherapy.

Description:

The overall objective of this study is to assess the effect of green tea on reducing the incidence or severity of chemotherapy (with or without radiotherapy) induced mucositis in patients receiving standard therapy that will produce a very high likelihood of oral, esophageal, or gastrointestinal mucositis (e.g. high dose chemotherapy with stem cell reconstitution in patients with multiple myeloma; concurrent 5-FU/ cisplatin and radiotherapy to the head and neck area; patients receiving paclitaxel).

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 37
• Est. completion date: March 2006
• Est. primary completion date: March 2006
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

Histologically confirmed diagnosis of cancer for which standard chemotherapy will produce a very high likelihood of oral, esophageal or gastrointestinal mucositis (e.g. high dose chemotherapy with stem cell reconstitution in patients with multiple myeloma; concurrent 5-FU/ cisplatin and radiotherapy to the head and neck area; patients receiving paclitaxel). Patients receiving concurrent chemotherapy/radiation therapy for lung or gastrointestinal cancer are eligible.

If not receiving a highly mucosally toxic regimen, have had Grade 2 mucositis on the prior cycle of chemotherapy Have no evidence of active infection in the oral cavity such as thrush, HSV, or aphthous ulcers.

Patients must be free of known infectious stomatitis or systemic infection (culture not required). If unclear that the patient has infectious stomatitis, cultures may be obtained and the patient entered on study.

Must be free of Grade 3 or 4 vomiting. Have no contraindication for buccal scrapings. Not be a frequent (>3 cups per day) tea drinker Must be able to speak English.

Exclusion Criteria:

Xerostomia Use of any investigational agent (not FDA approved) Current use of, allopurinol, prostaglandin inhibitors, sulcralfate, vitamin E or antioxidant supplements during the course of this study.

Patients receiving an anesthetic "cocktail" regimen or other topical anesthetics.

Patients with existing oral lesions.

Study Design

Allocation: Non-Randomized, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Mucositis

Intervention

Drug:
• Administration of the antineoplastic

Locations

Country	Name	City	State
United States	Cancer Institute of New Jersey	New Brunswick	New Jersey

Sponsors (1)

Lead Sponsor	Collaborator
University of Medicine and Dentistry of New Jersey

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Assess the effect of tea on reducing the incidence or severity of chemotherapy induced mucositis
Secondary	Correlate the levels of tea polyphenols in buccal cells and in saliva with the effect of tea on the change in incidence or severity of treatment induced mucositis.
Secondary	Correlate the analyses of proliferation index, cyclooxygenase, and prostagladin E- 2 with the change in incidence or severity of chemotherapy induced mucositis.