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

Primary Purpose

Mucositis, Head and Neck Cancer

Status

Completed

Phase

Phase 1

Locations

United States

Study Type

Interventional

Intervention

Saline

Traumeel S

About this trial

This is an interventional treatment trial for Mucositis focused on measuring Radiation-Induced Mucositis, Head and neck cancer, TRAUMEEL, Mucositis, Radiation, Oral cancer, Inflammation of the mouth, Homeopathic Medication

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts 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

Sites / Locations

University of Oklahoma Health Sciences Center

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Placebo Comparator

Experimental

Arm Label

Arm Description

Saline

Traumeel S 1 mL

Traumeel S 2 mL

Traumeel S 3 mL

Outcomes

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

Secondary Outcome Measures

Full Information

NCT ID

NCT00584597

First Posted

December 20, 2007

Last Updated

December 10, 2010

Sponsor

University of Oklahoma

1. Study Identification

Unique Protocol Identification Number

NCT00584597

Brief Title

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

Acronym

TRAUMEEL

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

December 2010

Overall Recruitment Status

Completed

Study Start Date

October 2005 (undefined)

Primary Completion Date

October 2010 (Actual)

Study Completion Date

October 2010 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor

University of Oklahoma

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Mucositis, Head and Neck Cancer

Keywords

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

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 1

Interventional Study Model

Parallel Assignment

Masking

Participant

Allocation

Randomized

Enrollment

14 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Arm Type

Placebo Comparator

Arm Description

Saline

Arm Title

Arm Type

Experimental

Arm Description

Traumeel S 1 mL

Arm Title

Arm Type

Experimental

Arm Description

Traumeel S 2 mL

Arm Title

Arm Type

Experimental

Arm Description

Traumeel S 3 mL

Intervention Type

Drug

Intervention Name(s)

Saline

Intervention Description

Saline Control

Intervention Type

Drug

Intervention Name(s)

Traumeel S

Intervention Description

Traumeel S 1 mL

Intervention Type

Drug

Intervention Name(s)

Traumeel S

Intervention Description

Traumeel S 2mL

Intervention Type

Drug

Intervention Name(s)

Traumeel S

Intervention Description

Traumeel S 3mL

Primary Outcome Measure Information:

Title

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

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility 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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Greg Krempl, MD

Organizational Affiliation

University of Oklahoma

Official's Role

Principal Investigator

Facility Information:

Facility Name

University of Oklahoma Health Sciences Center

City

Oklahoma City

State/Province

Oklahoma

ZIP/Postal Code

73104

Country

United States

12. IPD Sharing Statement

Learn more about this trial

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

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