|
|
Home
Search
Study Topics
Glossary
|
 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|||||||||||||||||||||||||||||||||||||||||||||
| Sponsored by: |
University of Oklahoma |
|---|---|
| Information provided by: | University of Oklahoma |
| ClinicalTrials.gov Identifier: | NCT00584597 |
Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Radiation-Induced Mucositis Head and Neck Cancer |
Drug: Saline Drug: Traumeel S |
Phase I |
| Study Type: | Interventional |
| Study Design: | Treatment, Randomized, Single Blind (Subject), Placebo Control, Parallel Assignment, Safety Study |
| Official Title: | The Safety and Efficacy of the Homeopathic Medication TRAUMEEL S for the Treatment of Radiation-Induced Mucositis |
| Estimated Enrollment: | 20 |
| Study Start Date: | October 2005 |
| Estimated Study Completion Date: | October 2009 |
| Estimated Primary Completion Date: | October 2009 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
1: Placebo Comparator
Saline
|
Drug: Saline
Saline Control
|
|
2: Experimental
Traumeel S 1 mL
|
Drug: Traumeel S
Traumeel S 1 mL
|
|
3: Experimental
Traumeel S 2 mL
|
Drug: Traumeel S
Traumeel S 2mL
|
|
4: Experimental
Traumeel S 3 mL
|
Drug: Traumeel S
Traumeel S 3mL
|
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.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations| Contact: Dini Chissoe, BS | 405-271-5504 | geraldine-chissoe@ouhsc.edu |
| Contact: Ingrid Block, RN, MS | 405-271-8777 | ingrid-block@ouhsc.edu |
| United States, Oklahoma | |
| University of Oklahoma Health Sciences Center | Recruiting |
| Oklahoma City, Oklahoma, United States, 73104 | |
| Principal Investigator: | Greg Krempl, MD | University of Oklahoma |
More Information
| Responsible Party: | University of Oklahoma Health Sciences Center ( Greg Krempl, MD ) |
| Study ID Numbers: | TRAUMEEL_S_Krempl |
| Study First Received: | December 20, 2007 |
| Last Updated: | December 10, 2008 |
| ClinicalTrials.gov Identifier: | NCT00584597 |
| Health Authority: | United States: Food and Drug Administration |
|
Radiation-Induced Mucositis Head and neck cancer TRAUMEEL Mucositis |
Radiation Oral cancer Inflammation of the mouth Homeopathic Medication |
|
Mouth Diseases Digestive System Diseases Mucositis Gastrointestinal Diseases Oral cancer Head and Neck Neoplasms |
Stomatognathic Diseases Gastroenteritis Lip and oral cavity cancer Mouth Neoplasms Inflammation |
|
Neoplasms Neoplasms by Site |
