NCT00584597

A Trial of Homeopathic Medication TRAUMEEL S for the Treatment of Radiation-Induced Mucositis

The Safety and Efficacy of the Homeopathic Medication TRAUMEEL S for the Treatment of Radiation-Induced Mucositis

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 14 (actual)
• Sponsor: University of Oklahoma · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

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.

Detailed description

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.

Conditions

• Mucositis
• Head and Neck Cancer

Interventions

Type	Name	Description
DRUG	Saline	Saline Control
DRUG	Traumeel S	Traumeel S 1 mL
DRUG	Traumeel S	Traumeel S 2mL
DRUG	Traumeel S	Traumeel S 3mL

Timeline

• Start date: 2005-10-01
• Primary completion: 2010-10-01
• Completion: 2010-10-01
• First posted: 2008-01-02
• Last updated: 2010-12-13

Locations

1 site across 1 country: United States