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

This study has been completed.
Sponsor:
Information provided by:
University of Oklahoma
ClinicalTrials.gov Identifier:
NCT00584597
First received: December 20, 2007
Last updated: December 10, 2010
Last verified: December 2010
History of Changes
  Purpose

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 Intervention Phase
Mucositis
Head and Neck Cancer
 Drug: Saline
Drug: Traumeel S
 Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Treatment
Official Title: The Safety and Efficacy of the Homeopathic Medication TRAUMEEL S for the Treatment of Radiation-Induced Mucositis

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by University of Oklahoma:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: Yes ]

Enrollment: 14
Study Start Date: October 2005
Study Completion Date: October 2010
Primary Completion Date: October 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

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
Study First Received: December 20, 2007
Last Updated: December 10, 2010
Health Authority: United States: Food and Drug Administration

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

ClinicalTrials.gov processed this record on May 16, 2013