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

This study has been terminated.
(slow accrual)
Sponsor:
Information provided by:
Rutgers, The State University of New Jersey
ClinicalTrials.gov Identifier:
NCT00176514
First received: September 12, 2005
Last updated: December 10, 2009
Last verified: December 2009
  Purpose

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.


Condition Intervention
Mucositis
Drug: Administration of the antineoplastic

Study Type: Interventional
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

Further study details as provided by Rutgers, The State University of New Jersey:

Primary Outcome Measures:
  • Assess the effect of tea on reducing the incidence or severity of chemotherapy induced mucositis

Secondary Outcome Measures:
  • 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.

Estimated Enrollment: 37
Study Start Date: July 2000
Study Completion Date: March 2006
Primary Completion Date: March 2006 (Final data collection date for primary outcome measure)
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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00176514

Locations
United States, New Jersey
Cancer Institute of New Jersey
New Brunswick, New Jersey, United States, 08901
Sponsors and Collaborators
University of Medicine and Dentistry of New Jersey
Investigators
Principal Investigator: Susan Goodin, PharmD Rutgers, The State University of New Jersey
  More Information

No publications provided

Responsible Party: Susan Goodin, PhD, UMDNJ/CINJ
ClinicalTrials.gov Identifier: NCT00176514     History of Changes
Other Study ID Numbers: 3074, 060001
Study First Received: September 12, 2005
Last Updated: December 10, 2009
Health Authority: United States: Food and Drug Administration

Keywords provided by Rutgers, The State University of New Jersey:
mucositis

Additional relevant MeSH terms:
Mucositis
Digestive System Diseases
Gastroenteritis
Gastrointestinal Diseases
Mouth Diseases
Stomatognathic Diseases
Antineoplastic Agents
Pharmacologic Actions
Therapeutic Uses

ClinicalTrials.gov processed this record on October 29, 2014