NCT00584597

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
14

participants targeted

Target at below P25 for phase_1

Timeline
Completed

Started Oct 2005

Longer than P75 for phase_1

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2005

Completed
2.2 years until next milestone

First Submitted

Initial submission to the registry

December 20, 2007

Completed
13 days until next milestone

First Posted

Study publicly available on registry

January 2, 2008

Completed
2.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2010

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2010

Completed
Last Updated

December 13, 2010

Status Verified

December 1, 2010

Enrollment Period

5 years

First QC Date

December 20, 2007

Last Update Submit

December 10, 2010

Conditions

MucositisHead and Neck Cancer

Keywords

Radiation-Induced MucositisHead and neck cancerTRAUMEELMucositisRadiationOral cancerInflammation of the mouthHomeopathic Medication

Outcome Measures

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

    4 years

Study Arms (4)

1

PLACEBO COMPARATOR

Saline

Drug: Saline

2

EXPERIMENTAL

Traumeel S 1 mL

Drug: Traumeel S

3

EXPERIMENTAL

Traumeel S 2 mL

Drug: Traumeel S

4

EXPERIMENTAL

Traumeel S 3 mL

Drug: Traumeel S

Interventions

SalineDRUG

Saline Control

1
Traumeel SDRUG

Traumeel S 1 mL

2

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Oklahoma Health Sciences Center

Oklahoma City, Oklahoma, 73104, United States

Location

MeSH Terms

Conditions

MucositisHead and Neck NeoplasmsMouth NeoplasmsStomatitis

Interventions

Sodium ChlorideTraumeel S

Condition Hierarchy (Ancestors)

GastroenteritisGastrointestinal DiseasesDigestive System DiseasesMouth DiseasesStomatognathic DiseasesNeoplasms by SiteNeoplasms

Intervention Hierarchy (Ancestors)

ChloridesHydrochloric AcidChlorine CompoundsInorganic ChemicalsSodium Compounds

Study Officials

  • Greg Krempl, MD

    University of Oklahoma

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

December 20, 2007

First Posted

January 2, 2008

Study Start

October 1, 2005

Primary Completion

October 1, 2010

Study Completion

October 1, 2010

Last Updated

December 13, 2010

Record last verified: 2010-12

Locations

US(1)