Herbal Mouthrinse for Oral Mucositis Study

• Status: Completed
• Trial end date: 2015-06-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Medical University of South Carolina
• Collaborator: National Cancer Institute (NCI)
• Treatments: Ascorbic Acid; Glycerol

Criteria

Inclusion Criteria:

• 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 Criteria:

• 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).