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

University of Oklahoma (OU)

Status and phase: Completed; Phase 1

Conditions: Head and Neck Cancer; Mucositis

Treatments: Drug: Traumeel S; Drug: Saline

Study type: Interventional

Funder types: Other

Identifiers

NCT00584597

TRAUMEEL_S_Krempl

Details and patient eligibility

About

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.

Full 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.

Enrollment: 14 patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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14 participants in 4 patient groups, including a placebo group

1

Placebo Comparator group

Description:

Saline

Treatment:

Drug: Saline

2

Experimental group

Description:

Traumeel S 1 mL

Treatment:

Drug: Traumeel S

Drug: Traumeel S

Drug: Traumeel S

3

Experimental group

Description:

Traumeel S 2 mL

Treatment:

Drug: Traumeel S

Drug: Traumeel S

Drug: Traumeel S

4

Experimental group

Description:

Traumeel S 3 mL

Treatment:

Drug: Traumeel S

Drug: Traumeel S

Drug: Traumeel S