Clinical Trial: A Pilot Trial to Assess the Effects of Green Tea in the Prevention of Therapy-Induced Mucositis
Study Status: Terminated
Recruit Status: Terminated
Study Type: Interventional
Official Title: A Pilot Trial to Assess the Effects of Green Tea in the Prevention of Therapy-Induced Mucositis
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 chemotherapy.
Detailed Summary: 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).
Sponsor: University of Medicine and Dentistry of New Jersey
Current Primary Outcome: Assess the effect of tea on reducing the incidence or severity of chemotherapy induced mucositis
Original Primary Outcome: Same as current
Current Secondary Outcome:
- 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.
Original Secondary Outcome: Same as current
Information By: Rutgers, The State University of New Jersey
Dates:
Date Received: September 12, 2005
Date Started: July 2000
Date Completion:
Last Updated: December 10, 2009
Last Verified: December 2009
