Efficacy of Gelclair oral gel in the treatment of oral mucositis in patients with head and neck tumours treated with chemotherapy and /or radiotherapy

Background: During radiotherapy or chemotherapy of head and neck tumours patients commonly suffer from oral mucositis. Symptoms of oral mucositis are pain; discomfort or inability to tolerate food and fluid. Mucositis can be severe and limit the patient’s ability to tolerate chemotherapy or radiotherapy, cause delay and limit the effectiveness of cancer therapy. Aim: To examine effectiveness of gelclair oral gel in the treatment of oral mucisitis in patients with head and neck tumours during radiotherapy or/and chemotherapy. Material and method: This is nonrandomized, prospective study. We included 15 patients treated with radiotherapy and/or chemotherapy and proven head and neck tumours. During their oncology therapy they were treated with gelclear oral gel and checked every day for severity of their symptoms. Results: In the 13 patients significant improvement in the management of pain was observed, and 11 patients had improvement in food and fluid intakes. There were no delays in treatment, caused by severity of oral mucositis. Conclusion: Gelclear oral gel is safe and efficient agent in the treatment of oral mucositis, one of most common complication of radiotherapy and/or chemotherapy in patients with head and neck tumours. This study was supported by Pharma Swiss – department Sarajevo, Bosnia and Herzegovina. INTRODUCTION Malignant head and neck tumours represent about 4% of all malignancies. Squamous cancers of the upper aero digestive tract constitute approximately 6% of new cancer cases in men and 2% in female at all sites, except the salivary glands; there is a significant preponderance of cases in men1. It is most common between 45 to 70 years2. In the time of diagnosis about 70 % of patients are in III or IV stage of disease3. Treatment options include surgery, radiotherapy and chemotherapy, before, during or after radiotherapy. If the patients are treated with radio and/or chemotherapy one of the most common side effects is oral mucositis. It occurs in 20-40% of patients treated with chemotherapy alone and up to 50% of patients receiving combination radiation and chemotherapy, especially those with head and neck tumors. Main symptoms of oral mucositis are: erythema, taste loss, pain, and a sore or dry mouth, swallowing and eating difficulty. Tooth and gum disease further complicate the problem. Reduction of caloric intake can lead to weight loss, loss in muscle mass strength and other complications, including a decrease in immunity. Patients with damaged oral mucosa and reduced immunity are prone to opportunistic mouth infections. The potential impact of morbidity and mortality with oral mucositis should not be underestimated and requires active treatment. The consequences of mucositis can be mild requiring little intervention to severe that may result in fatal complications. If oral mucisitis is not treated it can cause delays in chemotherapy and/or radiotherapy treatment, or even stopping of specific oncology treatments and compromise survival. Efficacy of Gelclair oral gel in the treatment of oral mucositis in patients with head and neck tumours treated with chemotherapy and /or radiotherapy 2 of 6 Many different treatment options can be used to prevent and treat oral muciositis. Oral care protocols including dental work before starting therapy and oral cleaning during the therapy. Mouth wash products, antiseptic, antibacterial, antifungal, antiviral, and many other products were used. It is obvious that many interventions used in clinical practice have never been rigorously evaluated. There is no standard evidence based 1 protocol for treatment of oral mucisitis during radio and/or chemotherapy. 7 Gel clear oral gel was approved in 2001 by FDA, for treatment of oral mucositis. This product still is not on the positive list of medication for patients in Bosnia and Herzegovina. PATIENTS AND METHODS In the period from January to Jul 2008 15 patients were included in this study. They had pathologically proven head and neck tumor, 13 were males and 2 females. Surgery was performed in 14 patients, and all 14 had adjuvant radiotherapy, among them 9 were treated with radio and chemo therapy. One patient had just radio and chemo therapy, and 5 just adjuvant radiotherapy after surgery. Radiotherapy of the tumor and neck with two opposite field, and one anterior supraclavicular field was used technique in 14 patients; one was irradiated with two small opposed fields on larynges. Two to three cycles of chemotherapy with cisplatin 100 mg and 5 fluorouracil 1000 mg was given prior to radiotherapy in 9 patients, and in 5 patients cisplatin was given alone on the day 1, 21 and 42 of radiotherapy treatment. During their oncology therapy we evaluated grade of oral mucositis by WHO scale. In the second week of radiotherapy they started with gel clear oral gel standard treatment for oral mucositis. Figure 1 Table 1. WHO scale of oral mucositis Figure 2 Table 2. Patients by the age The most of patients were 60 and older, average age 61 (26-76 years) Figure 3 Table 3 . Patients by the diagnosis The most of patients were diagnosed as carcinoma of laryngis and carcinoma of oropharingis, and with advanced disease. Figure 4 Table 5. Patients by the treatment The most of patients had combined therapy.