Status:
COMPLETED
Herbal Mouthrinse for Oral Mucositis Study
Lead Sponsor:
Medical University of South Carolina
Collaborating Sponsors:
National Cancer Institute (NCI)
Conditions:
Oral Mucositis
Eligibility:
All Genders
18-89 years
Phase:
PHASE2
Brief Summary
This study involves adults receiving radiation therapy for head and neck cancer and will test whether or not the study mouthrinse may lessen oral mucositis.
Detailed Description
The broad goal of our research is development of an effective Complementary and Alternative Medicine (CAM) approach to prevent mucositis or lessen its severity and complications. Oral mucositis (OM) i...
Eligibility Criteria
Inclusion
- Anatomic site: lip (inner aspect), oral cavity, pharynx or larynx; includes tonsils and salivary glands (ICD-9: 140-149 or 161).
- Malignant tumor: ICD-O morphology 2 (in situ) or 3 (malignant, invasive or infiltrating).
- Adult aged 18-89 years.
- Patient recommended or planned to undergo radiotherapy to the head and neck regions, as part of their cancer treatment regimen.
- Radiotherapy to be given in standard doses over a 4 - 7 week period.
Exclusion
- Prior radiation treatment for cancer of the oral cavity, head or neck.
- Baseline mouth and throat soreness (MTS) extreme score of 4.
- Eastern Cooperative Oncology Group (ECOG) performance status \>2.
- Unable to sign Informed Consent.
- Known history of allergy to any of the mouthrinse constituents (aloe, anise, ascorbic acid, clove, glycerin, peppermint, poloxamer 407, potassium sorbate, spearmint, thyme, water, xylitol).
- Inability to use a mouth rinse.
- Patient unable to communicate with study personnel in English (either themselves or an interpreter).
Key Trial Info
Start Date :
July 1 2013
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 2015
Estimated Enrollment :
50 Patients enrolled
Trial Details
Trial ID
NCT01898091
Start Date
July 1 2013
End Date
June 1 2015
Last Update
March 6 2017
Active Locations (1)
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1
Medical University of South Carolina
Charleston, South Carolina, United States, 29425-9170