Ultramulsion Mitigates Radiation-induced Mucosal Dehydration and Salivary Hypofunction

Objectives: Radiation-induced salivary gland injury results in chronic xerostomia in patients being treated for cancers of the head and neck and is associated with a range of undesirable outcomes including dysphagia, dysgeusia, severe pain, increased risk of infection and poor quality of life. The objective of this study was to compare the efficacy of two formulations of an ultramulsion gel containing a natural Spilanthes extract(Medactive® Oral Gel) in mitigating mucosal injury, dehydration and xerostomia following directed fractionated head and neck
Methods: Male Wistar rats were exposed to 3 fractions of 7.5 Gy of X-radiation on days 0, 1 and 2. Two groups of animals(n=7/group) were randomized to receive oral(topical) administration of one of two formulations(MedActive Oral Relief Gel Ultramulsion 720 flake or L1220 Liquid) three times daily from day 7 to day 9. An additional group(n=8) was treated with vehicle control(saline) using the same schedule. A group of radiation-naïve control animals(n=6) was included for comparison. The animals were scored for mucosal health using a standard quantitative scale. Saliva production was determined using modified Schirmer strips. Tissue hydration and mucosal integrity were assessed using previously established Optical Coherence Tomography(OCT).
Results: Both test formulations favorably and equally impacted study endpoints. Whereas radiation control animals demonstrated evidence of early mucosal damage, tissue treated with test article had better OCT surface integrity scores and less overt clinical injury. OCT analysis demonstrated enhanced tissue hydration among treated animals compared to controls which was consistent with measurements of pooled saliva.
Conclusions: The data suggests that both formulations of the ultramulsion gel containing natural Spilanthes favorably affected saliva levels and tissue response among animals receiving a course of fractionated radiation, and provides the basis for additional studies to assess the role for the compound in relieving the side effects of radiation-induced, and other forms of xerostomia.