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NCT00584597 Clinical Trial

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

Head and Neck Cancer Clinical Trial

— TRAUMEEL  

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00584597
Other study ID # TRAUMEEL_S_Krempl
Secondary ID
Status Completed
Phase Phase 1
First received December 20, 2007
Last updated December 10, 2010
Start date October 2005
Est. completion date October 2010

Study information
Verified date December 2010
Source University of Oklahoma
Contact n/a
Is FDA regulated No
Health authority United States: Food and Drug Administration
Study type Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility
Status Completed
Enrollment 14
Est. completion date October 2010
Est. primary completion date October 2010
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Both
Age group 18 Years and older
Eligibility 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

Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment

Related Conditions & MeSH terms

Intervention

Drug:
• Saline
Saline Control
• Traumeel S
Traumeel S 1 mL
• Traumeel S
Traumeel S 2mL
• Traumeel S
Traumeel S 3mL

Locations
Country Name City State
United States University of Oklahoma Health Sciences Center Oklahoma City Oklahoma

Sponsors (1)
Lead Sponsor Collaborator
University of Oklahoma

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary 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 Yes
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