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

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

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00584597

Acronym

TRAUMEEL

Enrollment

Registered

2008-01-02

Start date

2005-10-31

Completion date

2010-10-31

Last updated

2010-12-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Head and Neck Cancer, Mucositis

Keywords

Radiation-Induced Mucositis, Head and neck cancer, TRAUMEEL, Mucositis, Radiation, Oral cancer, Inflammation of the mouth, Homeopathic Medication

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.

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.

Interventions

DRUGSaline

Saline Control

DRUGTraumeel S

Traumeel S 1 mL

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

SINGLE (Subject)

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Yes

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

Design outcomes

Primary

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	4 years

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026