We updated the design of this site on December 18, 2017. Learn more.
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00584597
Recruitment Status : Completed
First Posted : January 2, 2008
Last Update Posted : December 13, 2010
Sponsor:
Information provided by:

Study Description
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.

Condition or disease Intervention/treatment Phase
Mucositis Head and Neck Cancer Drug: Saline Drug: Traumeel S Phase 1

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 Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 14 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Official Title: The Safety and Efficacy of the Homeopathic Medication TRAUMEEL S for the Treatment of Radiation-Induced Mucositis
Study Start Date : October 2005
Primary Completion Date : October 2010
Study Completion Date : October 2010

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arms and Interventions

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


Outcome Measures

Primary Outcome Measures :
  1. 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 ]

Eligibility Criteria

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00584597


Locations
United States, Oklahoma
University of Oklahoma Health Sciences Center
Oklahoma City, Oklahoma, United States, 73104
Sponsors and Collaborators
University of Oklahoma
Investigators
Principal Investigator: Greg Krempl, MD University of Oklahoma
More Information

Responsible Party: Greg Krempl, MD, University of Oklahoma Health Sciences Center
ClinicalTrials.gov Identifier: NCT00584597     History of Changes
Other Study ID Numbers: TRAUMEEL_S_Krempl
First Posted: January 2, 2008    Key Record Dates
Last Update Posted: December 13, 2010
Last Verified: December 2010

Keywords provided by University of Oklahoma:
Radiation-Induced Mucositis
Head and neck cancer
TRAUMEEL
Mucositis
Radiation
Oral cancer
Inflammation of the mouth
Homeopathic Medication

Additional relevant MeSH terms:
Head and Neck Neoplasms
Mucositis
Neoplasms by Site
Neoplasms
Gastroenteritis
Gastrointestinal Diseases
Digestive System Diseases
Mouth Diseases
Stomatognathic Diseases