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

Abstract

One of the major side effects of radical radiation therapy for head and neck 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 using two "over-the-counter" oral comfort products - Biotene (toothpaste, mouthwash 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 postirradiation xerostomia. Twenty-eight patients with post-irradiation xerostomia were entered on the study. All had biopsy-proven carcinoma of the nasopharynx, oropharynx, oral cavity, hypopharynx or larynx, and had received primary radiotherapy with curative intent (> or =50 Gy in 20 fractions) more than 4 months before study entry. More than 75% of both parotid glands were included in the primary radiation field. There was no clinical evidence of recurrent disease. Patients were provided with a 2-month supply of Biotene mouthwash, toothpaste, chewing gum and Oralbalance gel. Response was evaluated 1 and 2 months after study entry using a patient-completed visual analogue scale to assess the severity of xerostomia and its effects on quality of life. For analysis, the scored baseline was subtracted from the later scores to assess change. Patients with an increase of 10 mm from their baseline score on the visual analogue scale were classified as having responded to the treatment intervention, and those with an increase of > or =25 mm from their baseline score were classified 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. Similar proportions of patients (46% some improvement, 25% major improvement) reported 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 that the use of Biotene (mouthwash, toothpaste and chewing gum) and Oralbalance gel can improve many of the symptoms of radiation-induced xerostomia. A placebo effect could account for many of the observed improvements in symptoms, and in order to assess the role of these agents in the management of patients with postirradiation xerostomia a randomised phase III study is needed.

Chewing Xylitol Gum Improves Self-Rated and Objective Indicators of Oral Health Status under Conditions Interrupting Regular Oral Hygiene

“…Presumably, an increased salivary bacteria quantity may contribute to increased VAS scores of oral conditions. This is consistent with previous studies reporting that malodor is correlated with oral hygiene status, including plaque control records and tongue-coating scores Pham et al 2011), and that the use of chewing gum helps improve oral discomfort (Warde et al 2000). In contrast to a previous finding that decreased saliva was correlated with oral dryness (Guggenheimer and Moore 2003), we found a significant increase in the dryness VAS score in the control group, while saliva increased after training.…”

“…The VAS has widely been used to measure clinical symptoms, such as oral malodor, discomfort, and dryness (Warde et al 2000;Ohrn et al 2001;Pai et al 2001;Gerdin et al 2005;Zaitsu et al 2011). Assessed oral conditions included malodor, discomfort, and dryness.…”

Prevenção da xerostomia e da mucosite oral induzidas por radioterapia com uso do laser de baixa potência

“…Essa xerostomia pode ser irreversí-vel, com tendência de recuperação de até 50% da quantia inicial de saliva, caso o volume da parótida irradiado e a dose final de irradiação fique em valores os mais baixos possíveis (8)(9)(10)(11)(12) . Várias técnicas são descritas na literatura para prevenção da xerostomia e da mucosite oral, como o uso de amifostina, pilocarpina, Biotene ® , bochechos com bicarbonato de sódio, uso de antibióticos e anestésicos tópicos, entre outros, todas com suas limitações (13)(14)(15)(16)(17)(18)(19) . Lasers de baixa potência (LBP) são lasers que possuem baixa energia, sem potencial fototérmico, sendo utilizados para biomodulação.…”

Total bacterial counts on oral mucosa after using a commercial saliva substitute in patients undergoing hematopoietic cell transplantation

“…Oralbalance® (Laclede, Inc., Rancho Dominguez, CA, USA), which is a commercially available saliva substitute, has been reported to alleviate the symptoms of post-radiotherapy xerostomia in head and neck cancer patients [4,8]. Therefore, this product may be effective in HCT patients.…”