Zinc-L-carnosine mouthwash in oral mucositis patients: a single-blind, randomized, controlled trial.

BACKGROUND

The study aims to evaluate the therapeutic efficacy of a zinc-L-carnosine mouthwash (Hepilor®) in the treatment of oral mucositis in cancer patients treated by radiation and/or chemotherapy.

METHODS

The study included 42 patients, randomly allocated to the Test Group (N.=22) or to the Control Group (N.=20), referred to University Hospital of Marche Region, Ancona, Italy. The oral mucositis and its adverse manifestation were evaluated by the National Cancer Institute Common Toxicity Criteria scales. Hepilor® (4 rinses/day with 10 mL of pure product, for 3 minutes, for 30 days) was administered to the Test Group. To Control Group was prescribed 2 daily rinses with water and sodium bicarbonate, for one minute, for 30 days. Each evaluation was performed at the time of patient enrolment (t0), after 15 days (t1) and 30 days (t2) from the beginning of the treatment.

RESULTS

In Test Group, the moderate and severe mucositis (t0: 61%), its related symptoms (t0: 5-59%), and the use of analgesics (t0: 63%) were significantly reduced, both at t1 (28%; 0-14%; 14%; P<0.0001) and at t2 (14%; 0-5%; 0%; P<0.0001). In Control Group, the patients with severe mucositis (t0: 10%) and oral symptoms (t0: 0-56%) notably increased, especially at t2 (35%; 10-75%), as well as analgesic drugs intake (t0: 35%; t2: 75%; P<0.0001).

CONCLUSIONS

These data confirm the clinical efficacy of Hepilor® in the treatment of oral mucositis in cancer patients. Together with an adequate oral hygiene, it reduced the severity of oral mucositis and its related symptoms, improving patients' quality of life.