A Pilot Trial to Assess the Effects of Green Tea in the Prevention of Therapy-Induced Mucositis
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.
|Study Design:||Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||A Pilot Trial to Assess the Effects of Green Tea in the Prevention of Therapy-Induced Mucositis|
- Assess the effect of tea on reducing the incidence or severity of chemotherapy induced mucositis
- 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.
- Correlate the analyses of proliferation index, cyclooxygenase, and prostagladin E- 2 with the change in incidence or severity of chemotherapy induced mucositis.
|Study Start Date:||July 2000|
|Study Completion Date:||March 2006|
|Primary Completion Date:||March 2006 (Final data collection date for primary outcome measure)|
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).
|United States, New Jersey|
|Cancer Institute of New Jersey|
|New Brunswick, New Jersey, United States, 08901|
|Principal Investigator:||Susan Goodin, PharmD||Rutgers, The State University of New Jersey|