This study was a clinical randomized controlled trial (from 2008 to 2009), conducted in Radiation Oncology Department of Seyed-al-Shohada Hospital, Isfahan University of Medical Sciences, on some head and neck cancer patients, with no age and sex limitation that received at least 4000 cGY RT with parallel opposed field and daily fraction of 180 cGY.
Ethical approval was obtained from the local research ethics committee in school of medicine before recruitment. The study was performed in accordance with published guidelines and is reported in accordance with the CONSORT statement. Except salivary gland cancer, head and neck cancer patients were eligible for an enrolment. They received radiotherapy and went away at least 2 months from their treatment, but they would be excluded if they had diseases associated with xerostomia (such as autoimmune disease, connective tissue disease, etc.), used drugs which xerostomia is one of their side effects, and had a past history of radiotherapy in head and neck cancer region.
The main objective was to evaluate whether Bioxtra gel would improve radiation-induced xerostomia, lactobacillus colony count, candida albicans in the saliva cultures and oral cavity PH.
55 patients were defined as eligible patients. Written informed consent was recorded from subjects who agreed to participate.
The primary end-point was xerostomia, which was measured at the end of 2 weeks after finishing therapy. Candida albicans, lactobacillus colony count, and oral cavity PH measured as secondary end-points at the end of treatment for increasing power coefficient of xerostomia.
At the first day of treatment, xerostomia and saliva stream evaluated by some questions such as whether patients had complained of xerostomia during days or nights, felt xerostomia while eating, drank water for swallowing dry food and if avoided talking to people because of xerostomia. One absolute positive answer to at least one of these questions presents decreased saliva. Then, we used a special table for scoring in order from 0 to 1. Then, we tried to find the mean score of the patients and analyzed with Chi-square test.
The other options evaluated are basic PH with PH strip, basic lactobacillus colony count and candida albicans of the mouth in special cultures in laboratory. Then, patients were recommended to drink water when they need to and use ice chips to wet their mouth. Chewing gum, using lemon, avoidance of hot or cold and peppery food was also recommended.
Patients received 2 Bioxtra gel for 2 weeks (1 spoon, 3 times a day). They went for assessment of xerostomia, swallowing, and oral cavity examined for infections and teeth condition. After 2 weeks, xerostomia evaluated again by the same questions, and oral cavity PH, lactobacillus colony count and candida albicans checked in laboratory.
Qualitative results such as xerostomia were compared by using Chi-square test and quantitative results such as oral cavity PH, lactobacillus colony count and candida albicans used t-test.