Double-blind, randomized pilot study of bioadhesive chlorhexidine gel in the prevention and treatment of mucositis induced by chemoradiotherapy of head and neck cancer

Abstract

BackgroundTo evaluate, in an initial way, the effectiveness of bioadhesive chlorhexidine gel 0.2% versus placebo as a preventive and therapeutic intervention of oral mucositis induced by radiation therapy and chemotherapy in patients diagnosed with head and neck cancer treated with chemoradiotherapy.Material and MethodsIn this pilot study, 7 patients (range of age: 18- 65), having histological documented diagnosis of squamous carcinoma on the head and neck region in stage III and IV, and receiving combined radiation treatment and chemotherapy (cisplatin 100 mg/m2 IV on days 1, 22, and 43 of irradiation) were studied. Simultaneously, a topical application was performed with bioadhesive chlorhexidine gel 0.2% in the study group, and the placebo gel for the control group in 5 applications per day, from the time of initiation of cancer treatment to 2 weeks after completion of chemo-radiotherapy treatment (11 weeks of follow-up). The gradation of mucositis, pain, analgesic consumption, infectious complications, and treatment tolerance was measured.ResultsAfter 7 patients completed the protocol, any differences were observed between groups in an interval analysis. Mucositis, pain, and tolerance was similar in both groups.ConclusionsOur results must be interpreted with caution due to the reduced sample size, but the use of bioadhesive chlorhexidine gel 0.2% didn’t contribute clinical improvement to the oral mucositis induced by radiation therapy and chemotherapy. Key words: Chlorhexidine, mucositis, head and neck cancer.

MASCC/ISOO clinical practice guidelines for the management of mucositis secondary to cancer therapy

“…If CHX is indicated because of concurrent oral infection and OM, it is acceptable to use it for the oral infection. The new RCTs were based on another patient population (RT-CT for H&N cancer) 19 or for another aim (treatment for OM rather than prevention of OM). 20 BOC remains an important best practice for patients undergoing cancer treatments; however, as a research area, there is limited evidence from high-quality, rigorous studies.…”

Chlorhexidine Gel Use in the Oral District: A Systematic Review

“…Freudenthal et al [27] concluded that there are statistically important differences in alveolar osteitis between chlorhexidine and non-use after a third molar surgery. According to Diaz-Sanchez [28], chlorhexidine gel 0.2% did not contribute clinical improvement in patients undergoing radiation therapy and chemotherapy [52]. In the second evaluated study by Haraji et al [29], an intra-alveolar application of chlorhexidine gel could contribute to a lower risk of dry socket.…”

Weekly Low-Dose Versus Three-Weekly High-Dose Cisplatin for Concurrent Chemoradiation in Locoregionally Advanced Non-Nasopharyngeal Head and Neck Cancer: A Systematic Review and Meta-Analysis of Aggregate Data

“…Fifty‐two prospective trials with 4,209 patients, treated with radiation and single‐agent concurrent cisplatin, were included in two separate meta‐analyses comparing weekly versus three‐weekly cisplatin schedules in the settings of postoperative (three vs. six studies, respectively, and two relevant study updates) and definitive radiotherapies (14 vs. 25 studies; two relevant study updates) . There were 34 randomized trials (excluding the study updates), of which 11 compared chemoradiotherapy with radiotherapy; five explored targeted agents (lapatinib, gefitinib, erlotinib, panitumumab) combined with either cisplatin‐based chemoradiotherapy or radiotherapy alone; four explored other cytotoxic drugs (vinorelbin, paclitaxel, 5‐fluorouracil) combined with either chemoradiotherapy or radiotherapy alone; seven investigated supportive care drugs, measures, or radiosensitizers (trolamine emulsion, Lactobacillus brevis CD2 lozenges, tirapazamine, palifermin, low‐level laser therapy, bioadhesive chlorhexidine gel) added to chemoradiotherapy; four compared different chemoradiation schedules (concurrent vs. sequential, conventional vs. altered fractionation) and routes of cisplatin administration (intravenous vs. intra‐arterial); and in two studies, induction chemotherapy was tested prior to chemoradiation . Only one small randomized trial compared weekly versus three‐weekly chemoradiation for postoperative LA‐SCCHN, and the data were used in both meta‐analyses accordingly .…”