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

December 10, 2010 updated by: University of Oklahoma

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

14

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Oklahoma
      • Oklahoma City, Oklahoma, United States, 73104
        • University of Oklahoma Health Sciences Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: 1
Saline
Drug: Saline
Saline Control
Experimental: 2
Traumeel S 1 mL
Drug: Traumeel S
Traumeel S 1 mL
Drug: Traumeel S
Traumeel S 2mL
Drug: Traumeel S
Traumeel S 3mL
Experimental: 3
Traumeel S 2 mL
Drug: Traumeel S
Traumeel S 1 mL
Drug: Traumeel S
Traumeel S 2mL
Drug: Traumeel S
Traumeel S 3mL
Experimental: 4
Traumeel S 3 mL
Drug: Traumeel S
Traumeel S 1 mL
Drug: Traumeel S
Traumeel S 2mL
Drug: Traumeel S
Traumeel S 3mL

What is the study measuring?

Primary Outcome Measures

Outcome Measure
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
Time Frame: 4 years
4 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Oklahoma

Investigators

  • Principal Investigator: Greg Krempl, MD, University of Oklahoma

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2005

Primary Completion (Actual)

October 1, 2010

Study Completion (Actual)

October 1, 2010

Study Registration Dates

First Submitted

December 20, 2007

First Submitted That Met QC Criteria

December 31, 2007

First Posted (Estimate)

January 2, 2008

Study Record Updates

Last Update Posted (Estimate)

December 13, 2010

Last Update Submitted That Met QC Criteria

December 10, 2010

Last Verified

December 1, 2010

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • TRAUMEEL_S_Krempl

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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