Double-blind randomized study of oral glutamine on the management of radio/chemotherapy-induced mucositis and dermatitis in head and neck cancer

Abstract

Abstract. This randomized clinical trial was designed to determine whether glutamine administration was effective in reducing the incidence and severity of mucositis and dermatitis induced by radiotherapy (RT) or chemoradiotherapy (CHRT) in patients with head and neck cancer (HNC). Fifty patients were randomized to receive orally either L-Glutamine or placebo (25 patients in each arm). In the glutamine-treated group, 10 g of oral glutamine was administered three times daily. The primary endpoint was to compare the appearance of clinical mucositis between groups at the 6th week, according to the Common Terminology Criteria for Adverse Events. Secondary endpoints were: Functional mucositis, mucositis onset, cervicofacial dermatitis, pain, weight loss and assessment of quality of life (according to the M.D. Anderson Symptom Inventory-Head and Neck). In total, 76 and 87.5% developed clinical mucositis in the glutamine and placebo group, respectively. The incidence and severity grade of mucositis at the 6th week did not exhibit statistically significantly differences between the two groups, although it had a higher value in the placebo group. Significant reduction of dermatitis incidence (P=0.038) and severity (P=0.032) was found in the glutamine group. There were no differences in other outcomes such as pain, weight loss and mucositis onset, in treatment parameters including concomitant chemotherapy, radiation dose and previous surgery, or in quality of life. The present study revealed that glutamine provided slight clinical effects compared with placebo in terms of reducing oral mucositis induced by RT or CHRT in patients with HNC at the 6th week; however, the results were not statistically significant. Although the findings suggested a significant benefit in reducing the incidence and severity of dermatitis, further confirmatory studies are required. IntroductionRadiation therapy (RT) and concomitant chemoradiotherapy (CHRT) in patients with head and neck cancer (HNC) are commonly associated with complications such as mucositis and dermatitis in the oral cavity and on the cervicofacial area. Clinically, these adverse effects are able to cause severe pain and odinophagia, increase the risk of infections, skin wounds and inflammatory ulcers, limit deglutition, cause malnutrition and negatively impact the diet and overall quality of life of patients (1). The incidence rate of mucositis varies between 85 and 100%, depending on the cancer treatment regimen, with altered fractionated RT, CHRT or conventional RT (2,3), whereas the incidence of acute dermatitis varies between 7 and 25% (4,5), reaching up to 49% in patients receiving RT in combination with cetuximab (6).Numerous efforts have been made to identify effective agents for preventing and treating mucositis and dermatitis induced by RT or CHRT. Although some standard guidelines for management are available (7,8), reliable and effective treatments are lacking (9). For mucositis, intensive oral care protocols, antimicrobial agents, anti-inflammatory agents, cytopro...

Effects of oral supplementation in the management of oral mucositis in cancer patients: A meta‐analysis of randomized clinical trials

“…Thus, 39 articles remained for full‐text reading for eligibility (phase 2), and 27 studies were then excluded. In total, 12 articles were selected for data extraction and qualitative synthesis. Figure details this process of study selection.…”

“…All studies were reports of randomized clinical trials, published in the English language, between 2004 and 2018. The studies were divided by subgroups according to the following interventions: elental, glutamine, and zinc …”

“…The oral supplementations used as controls were placebo, maltodextrin, soybean oil and no treatment . 7 studies included patients undergoing chemoradiotherapy, 7 evaluated samples with patients undergoing RT, and 4 studies assessed patients undergoing CH …”

“…8 studies included patients with head and neck cancer, 2 studies included only patients with esophageal cancer in the sample, 1 study included patients with leukemia, and only 1 study included patients with multiple types of cancer. The descriptive characteristics of the included articles are summarized in Table .…”

“…Regarding secondary outcomes, 5 studies evaluated pain intensity using scores varying from 0 to 10. The pain intensity in groups receiving zinc (200 mg or 10 cc per meal, 3 times daily), for various types of cancer as a component of CH or RT, was significantly lower than in groups receiving placebo ( P < 0.05) .…”