An interventional study of Administration of the antineoplastic in Mucositis, sponsored by University of Medicine and Dentistry of New Jersey. Terminated at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2009-12-11.
Sponsored by University of Medicine and Dentistry of New Jersey · Not applicable, Interventional, and Treatment
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.
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).
488 studies on the registry are indexed under Mucositis; 70 are open to participants now.
This study's enrollment of 37 is below the median of 50 across 394 interventional studies indexed under Mucositis.
Browse Mucositis studies →University of Medicine and Dentistry of New Jersey is the lead sponsor of 103 studies on the registry; none are open to participants now.
Counted across the registry records on this site, refreshed daily.
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.
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.
This study is terminated, as verified in Dec 2009. You cannot join it, but the record below documents what was studied.
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University of Medicine and Dentistry of New Jersey