Status:
TERMINATED
A Pilot Trial to Assess the Effects of Green Tea in the Prevention of Therapy-Induced Mucositis
Lead Sponsor:
University of Medicine and Dentistry of New Jersey
Conditions:
Mucositis
Eligibility:
All Genders
18+ years
Phase:
NA
Brief 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 chemoth...
Detailed 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 st...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
July 1 2000
Trial Type :
INTERVENTIONAL
End Date :
March 1 2006
Estimated Enrollment :
37 Patients enrolled
Trial Details
Trial ID
NCT00176514
Start Date
July 1 2000
End Date
March 1 2006
Last Update
December 11 2009
Active Locations (1)
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1
Cancer Institute of New Jersey
New Brunswick, New Jersey, United States, 08901