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

Phase 1

Completed

• Conditions: Head and Neck Cancer; Mucositis
• Interventions: Drug: Saline; Drug: Traumeel S

• Registration Number: NCT00584597
• Lead Sponsor: University of Oklahoma

Brief 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.

Study Timeline

• Study Start: 2005-10
• Study First Submitted: 2007-12-20
• Study First Submitted QC: 2007-12-31
• Study First Posted: 2008-01-02
• Primary Completion: 2010-10
• Study Completion: 2010-10
• Status Verified: 2010-12
• Last Update Submitted: 2010-12-10
• Last Update Posted: 2010-12-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 14

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
1	Saline	Saline
2	Traumeel S	Traumeel S 1 mL
3	Traumeel S	Traumeel S 2 mL
4	Traumeel S	Traumeel S 3 mL

Primary Outcome Measures

Name	Time	Method
The specific aim will be to determine the safety of TRAUMEEL S for mucositis in head and neck cancer patients undergoing radiation therapy	4 years

Trial Locations

Locations (1)

University of Oklahoma Health Sciences Center; 🇺🇸 Oklahoma City, Oklahoma, United States