Herbal Mouthrinse for Oral Mucositis Study

Completed · Phase 2 · Has a placebo group

Conditions studied: Oral Mucositis

In brief

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.

Key facts

Study ID

NCT01898091

Run by

Medical University of South Carolina

People needed

50

Starts

2013-07-01

Expected to finish

2015-06-01

Last updated by the study team

2017-03-06

Who can join

Age: 18 and older, up to 89. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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).

Where it is running

• Medical University of South Carolina — Charleston, South Carolina, United States

Full record on ClinicalTrials.gov

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