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NCT Number: NCT00584597

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

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.

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Key information

Conditions

Mucositis Digestive System Diseases Gastroenteritis Gastrointestinal Diseases Head and Neck Cancer Head and Neck Neoplasms Mouth Diseases Mouth Neoplasms Neoplasms Neoplasms by Site Stomatitis Stomatognathic Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

University of Oklahoma Health Sciences Center

Oklahoma City, Oklahoma, 73104, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Saline

Drug

Saline Control

Traumeel S

Drug

Traumeel S 1 mL

Primary outcomes

  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

Sponsors and collaborators

Lead sponsor

University of Oklahoma

Other

Registry information

Official study title

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

Acronym: TRAUMEEL

Important dates

Study start
2005
Primary completion
2010
Study completion
2010
First posted
Jan 2, 2008
Registry last updated
Dec 13, 2010

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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