Clinical trial · Interventional

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

NCT00584597CI-TRIAL-00004186TRAUMEELcompletedPhase 1ClinicalTrials.gov clinicaltrialsPublishedExplore in graph →

Summary

Brief summary (as posted)

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.

Conditions

Conditions (2)

Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.

Condition (as posted)	Mapped entity	Match	Confidence
Head and Neck Cancer	Malignant Head and Neck Neoplasm	ALIAS	0.90
Mucositis	—	UNRESOLVED	—

Interventions

Interventions (2)

Intervention	Type	Mapped drug	Match
Saline	Drug	—	UNRESOLVED
Traumeel S	Drug	—	UNRESOLVED

Design

Arms and outcomes

Arms (4)

type
PLACEBO_COMPARATOR
label
1
description
Saline
interventionNames
1. Drug: Saline
type
EXPERIMENTAL
label
2
description
Traumeel S 1 mL
interventionNames
1. Drug: Traumeel S
type
EXPERIMENTAL
label
3
description
Traumeel S 2 mL
interventionNames

Eligibility

Eligibility (as posted)

Sex: All
Minimum age: 18 Years

Show eligibility criteria text

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

References

Publications (0)

Data not yet available

No reference posted for this study.

Registry

Dates and enrollment

Start: Oct 1, 2005
Primary completion: Oct 1, 2010
Completion: Oct 1, 2010
First posted: Jan 2, 2008
Last update posted: Dec 13, 2010
Enrollment: 14 (actual)
Lead sponsor: University of Oklahoma OTHER
Keywords: Radiation-Induced Mucositis, Head and neck cancer, TRAUMEEL, Mucositis, Radiation, Oral cancer, Inflammation of the mouth, Homeopathic Medication

Data updated 22 days agoSource updated Dec 13, 2010source: clinicaltrials

Locations

Locations by country (1)

Country	Sites	Recruiting
United States	1	0

Trial listing is informational. Eligibility is decided by the study team; contact information is on ClinicalTrials.gov.