A Pilot Trial to Assess the Effects of Green Tea in the Prevention of Therapy-Induced Mucositis
Tracking Information | |||||
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First Received Date ICMJE | September 12, 2005 | ||||
Last Updated Date | December 10, 2009 | ||||
Start Date ICMJE | July 2000 | ||||
Primary Completion Date | March 2006 (final data collection date for primary outcome measure) | ||||
Current Primary Outcome Measures ICMJE |
Assess the effect of tea on reducing the incidence or severity of chemotherapy induced mucositis | ||||
Original Primary Outcome Measures ICMJE | Same as current | ||||
Change History | Complete list of historical versions of study NCT00176514 on ClinicalTrials.gov Archive Site | ||||
Current Secondary Outcome Measures ICMJE |
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Original Secondary Outcome Measures ICMJE | Same as current | ||||
Current Other Outcome Measures ICMJE | |||||
Original Other Outcome Measures ICMJE | |||||
Descriptive Information | |||||
Brief Title ICMJE | A Pilot Trial to Assess the Effects of Green Tea in the Prevention of Therapy-Induced Mucositis | ||||
Official Title ICMJE | 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. |
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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). |
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Study Type ICMJE | Interventional | ||||
Study Phase | |||||
Study Design ICMJE | Allocation: Non-Randomized Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
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Condition ICMJE | Mucositis | ||||
Intervention ICMJE | Drug: Administration of the antineoplastic | ||||
Study Arm (s) | |||||
Publications * | |||||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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Recruitment Information | |||||
Recruitment Status ICMJE | Terminated | ||||
Enrollment ICMJE | 37 | ||||
Completion Date | March 2006 | ||||
Primary Completion Date | March 2006 (final data collection date for primary outcome measure) | ||||
Eligibility Criteria ICMJE | 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. |
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Gender | Both | ||||
Ages | 18 Years and older | ||||
Accepts Healthy Volunteers | No | ||||
Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||
Location Countries ICMJE | United States | ||||
Administrative Information | |||||
NCT Number ICMJE | NCT00176514 | ||||
Other Study ID Numbers ICMJE | 3074, 060001 | ||||
Has Data Monitoring Committee | No | ||||
Responsible Party | Susan Goodin, PhD, UMDNJ/CINJ | ||||
Study Sponsor ICMJE | University of Medicine and Dentistry New Jersey | ||||
Collaborators ICMJE | |||||
Investigators ICMJE |
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Information Provided By | University of Medicine and Dentistry New Jersey | ||||
Verification Date | December 2009 | ||||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |