|Phase I||Supportive care||Completed||18 to 99||Other||TRAUMEEL_S_Krempl|
The specific aim of this study will be to determine the safety of TRAUMEEL S for mucositis in head and neck cancer patients undergoing radiation therapy.
Further Study Information
Oral mucositis is a debilitating side effect of radiation therapy for head and neck cancer patients. The severe inflammation of the oral cavity can be detrimental to quality of life and cause interruption in vital cancer treatment. Despite numerous proposed therapies, an effective agent for oral mucositis has yet to be found. TRAUMEEL S, a homeopathic remedy made up of highly diluted botanical extracts and minerals, has shown benefit for mucositis in children undergoing chemotherapy. The objective of this study is to evaluate the safety of TRAUMMEL S in the prevention and treatment of radiation-induced oral mucositis. The patients will use the medication as a mouthwash during radiation therapy and will be evaluated weekly with physical examination criteria and questionnaires for symptoms and side effects.
- Head and neck cancer patients post resection of primary tumor with negative or microscopically positive surgical margins
- Patients undergoing planned radiation therapy
- Age 18 to 99
- Head and neck cancer patients post resection of primary tumor with grossly positive surgical margins
- Patients receiving adjuvant chemotherapy
- Pediatric patients (age < 18)
- Pregnant women
Trial Lead Organizations/Sponsors
Oklahoma University Cancer Institute
|Greg A. Krempl||Principal Investigator|
Link to the current ClinicalTrials.gov record.
NLM Identifer NCT00584597
Information obtained from ClinicalTrials.gov on November 20, 2012
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