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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Mucositis, Head and Neck Cancer

Intervention / Treatment
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* Drug: Saline
* Drug: Traumeel S
* Drug: Traumeel S
* Drug: Traumeel S


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: 1<br>Saline | Drug: Saline<br>* Saline Control<br>|
| Experimental: 2<br>Traumeel S 1 mL | Drug: Traumeel S<br>* Traumeel S 1 mL<br>|
| Experimental: 3<br>Traumeel S 2 mL | Drug: Traumeel S<br>* Traumeel S 2mL<br>|
| Experimental: 4<br>Traumeel S 3 mL | Drug: Traumeel S<br>* Traumeel S 3mL<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Radiation-Induced Mucositis, Head and neck cancer, TRAUMEEL, Mucositis, Radiation, Oral cancer, Inflammation of the mouth, Homeopathic Medication