Basic Trial Information
Trial Description
     Summary
     Further Trial Information
     Eligibility Criteria
Trial Contact Information

Basic Trial Information

Trial Description

Summary

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.

Eligibility Criteria

Inclusion Criteria:

• 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

• Nonsmokers

Exclusion Criteria:

• 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 Contact Information

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

Back to Top