Colella, G., Cannavale, R., Vicidomini, A., Rinaldi, G., Compilato, D., & Campisi, G. (2010). Efficacy of a spray compound containing a pool of collagen precursor synthetic aminoacids (l-proline, l-leucine, l-lysine and glycine) combined with sodium hyaluronate to manage chemo/radiotherapy-induced oral mucositis: Preliminary data of an open trial. International Journal of Immunopathology and Pharmacology, 23(1), 143-151.

Evaluate the efficacy of sodium hyaluronate to decrease pain and severity of oral mucositis

Patients affected by oral mucositis were consecutively recruited. Patients were instructed to apply the hylauronic based spray on oral lesions 3-4 times per day for 14 days after meals. All patients did mouth care, including oral rinses with 0.12% chlorhexidine gluconate based mouthwash 3 times daily. Patients were evaluated with oral examination and photo recording at baseline, at 24 hours, 72 hours, 7 days, and 14 days.

The study was comprised of 27 patients with a mean age of 61 (SD = 18.6 years) and a range of 18-96 years. There were 12 femailes and 15 males.

Diagnosis Information: Recent treatment for head and neck cancer, daily radiotherapy, or chemo for neoplasm

Other Key Characteristics: signs of at least grade 1 oral mucositis

Mutli-site: University of Naples and University Hospital of Palermo

Open label prospective clinical trial

• WHO mucositis scale
• Visual Analog Scale (VAS) for pain
• Clinical resolution index

Pain scores with VAS reduced over time and was significantly reduced after two hours from spray provision (p  < 0.0001). Similar differences were shown at every other measurement time point as well (p < 0.0001). Patients treated showed improvement of lesion at 72 h (p = 0.0005) and progressive improvement in ability to swallow food and liquids.

Findings suggest that hylauronic acid/sodium hyaluronate may be helpful for management of oral mucositis.

Small sample <30. No appropriate control group; variety in treatment regimens (chemo versus non-chemo) may skew results. Patients already had mucositis at study entry and were using chlorhexidine, which is contrary to guideline recommendations. It is unclear if this may have affected findings.

May be effective but what are side effects? Does it lead to numbing? What does it taste like? Etc.