Clinical trial NCT00176514: A Pilot Trial to Assess the Effects of Green Tea in the Prevention of Therapy-Induced Mucositis
Official title: A Pilot Trial to Assess the Effects of Green Tea in the Prevention of Therapy-Induced Mucositis
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Mucositis
Keywords: mucositis
Lead sponsor: Rutgers, The State University of New Jersey
Sponsor class: OTHER
First posted: 2005-09-15
Enrollment: 37
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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 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).

Eligibility criteria: 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.

Primary outcomes:
measure: Assess the effect of tea on reducing the incidence or severity of chemotherapy induced mucositis
Secondary outcomes:
measure: 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.
measure: Correlate the analyses of proliferation index, cyclooxygenase, and prostagladin E- 2 with the change in incidence or severity of chemotherapy induced mucositis.
Other outcomes:
Locations:
city: New Brunswick
country: United States
facility: Cancer Institute of New Jersey
state: New Jersey
Study officials:
affiliation: Rutgers, The State University of New Jersey
name: Susan Goodin, PharmD
role: PRINCIPAL_INVESTIGATOR
References: