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


Phase 1
18 Years
N/A
Not Enrolling
Both
Mucositis, Head and Neck Cancer

Thank you

Trial Information

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


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.


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

Type of Study:

Interventional

Study Design:

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

Outcome Measure:

The specific aim will be to determine the safety of TRAUMEEL S for mucositis in head and neck cancer patients undergoing radiation therapy

Outcome Time Frame:

4 years

Safety Issue:

Yes

Principal Investigator

Greg Krempl, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

University of Oklahoma

Authority:

United States: Food and Drug Administration

Study ID:

TRAUMEEL_S_Krempl

NCT ID:

NCT00584597

Start Date:

October 2005

Completion Date:

October 2010

Related Keywords:

  • Mucositis
  • Head and Neck Cancer
  • Radiation-Induced Mucositis
  • Head and neck cancer
  • TRAUMEEL
  • Mucositis
  • Radiation
  • Oral cancer
  • Inflammation of the mouth
  • Homeopathic Medication
  • Head and Neck Neoplasms
  • Mucositis

Name

Location
University of Oklahoma Health Sciences Center Oklahoma City, Oklahoma  73104