A phase II study of Biotene in the treatment of postradiation xerostomia in patients with head and neck cancer

One of the major side effects of radical radiation therapy for head and nec k malignancies is xerostomia, or dryness of the mouth. There is no clearly effective treatment for this condition, but we have observed that patients in our practice believe that their symptoms improve significantly when usin g two "over-the-counter" oral comfort products - Biotene (toothpaste, mouth wash and chewing gum) and Oralbalance gel. We decided to study these agents in a formal phase II study to evaluate their usefulness in patients with p ostirradiation xerostomia. Twenty-eight patients with post-irradiation xero stomia were entered on the study. All had biopsy-proven carcinoma of the na sopharynx, oropharynx, oral cavity, hypopharynx or larynx, and had received primary radiotherapy with curative intent (greater than or equal to 50 Gy in 20 fractions) more than 4 months before study entry. More than 75% of bo th parotid glands were included in the primary radiation field. There was n o clinical evidence of recurrent disease. Patients were provided with a 2-m onth supply of Biotene mouthwash, toothpaste, chewing gum and Oralbalance g el. Response was evaluated 1 and 2 months after study entry using a patient -completed visual analogue scale to assess the severity of xerostomia and i ts effects on quality of life. For analysis, the scored baseline was subtra cted from the later scores to assess change. Patients with an in crease of 10 mm from their baseline score on the visual analogue scale were classifie d as having responded to the treatment intervention, and those with an incr ease of greater than or equal to 25 mm from their baseline score were class ified as having experienced a major improvement in their symptoms. After 2 months of treatment, 15 patients (54%) reported an improvement in intraoral dryness and 10 of these patients (36%) reported a major improvement. Simil ar proportions of patients (46% some improvement, 25% major improvement) re ported an improvement in their ability to eat normally. Seventeen patients (61%) reported an improvement in oral discomfort, and 12 of these (43%) had a major improvement in their symptoms. The results of this study suggest t hat the use of Biotene (mouthwash, toothpaste and chewing gum) and Oralbala nce gel can improve many of the symptoms of radiation-induced xerostomia. A placebo effect could account for many of the observed improvements in symp toms, and in order to assess the role of these agents in the management of patients with postirradiation xerostomia a randomised phase III study is ne eded.