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


N/A
18 Years
N/A
Not Enrolling
Both
Mucositis

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Trial Information

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


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).


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.

Type of Study:

Interventional

Study Design:

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

Outcome Measure:

Assess the effect of tea on reducing the incidence or severity of chemotherapy induced mucositis

Principal Investigator

Susan Goodin, PharmD

Investigator Role:

Principal Investigator

Investigator Affiliation:

University of Medicine and Dentistry New Jersey

Authority:

United States: Food and Drug Administration

Study ID:

3074

NCT ID:

NCT00176514

Start Date:

July 2000

Completion Date:

March 2006

Related Keywords:

  • Mucositis
  • mucositis
  • Mucositis

Name

Location

Cancer Institute of New JerseyNew Brunswick, New Jersey  08901