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

NCT ID: NCT00584597

Last Updated: 2010-12-13

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

14 participants

Study Classification

INTERVENTIONAL

Study Start Date

2005-10-31

Study Completion Date

2010-10-31

Brief Summary

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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

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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.

Conditions

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Mucositis Head and Neck Cancer

Keywords

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

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

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1

Saline

Group Type PLACEBO_COMPARATOR

Saline

Intervention Type DRUG

Saline Control

2

Traumeel S 1 mL

Group Type EXPERIMENTAL

Traumeel S

Intervention Type DRUG

Traumeel S 1 mL

3

Traumeel S 2 mL

Group Type EXPERIMENTAL

Traumeel S

Intervention Type DRUG

Traumeel S 2mL

4

Traumeel S 3 mL

Group Type EXPERIMENTAL

Traumeel S

Intervention Type DRUG

Traumeel S 3mL

Interventions

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Saline

Saline Control

Intervention Type DRUG

Traumeel S

Traumeel S 1 mL

Intervention Type DRUG

Traumeel S

Traumeel S 2mL

Intervention Type DRUG

Traumeel S

Traumeel S 3mL

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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University of Oklahoma

OTHER

Sponsor Role lead

Responsible Party

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University of Oklahoma Health Sciences Center

Principal Investigators

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Greg Krempl, MD

Role: PRINCIPAL_INVESTIGATOR

University of Oklahoma

Locations

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University of Oklahoma Health Sciences Center

Oklahoma City, Oklahoma, United States

Site Status

Countries

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United States

Other Identifiers

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TRAUMEEL_S_Krempl

Identifier Type: -

Identifier Source: org_study_id