The Elental® elemental diet for chemoradiotherapy-induced oral mucositis: A prospective study in patients with oral squamous cell carcinoma.

Oral mucositis is a common adverse effect of cancer treatment that can increase the risk for local and systemic infection. This prospective study was designed to evaluate the preventive effects of an amino-acid-rich elemental diet (ED), Elental®, on radiotherapy- or chemoradiotherapy-induced mucositis in oral squamous cell carcinoma (OSCC) patients. Fifty patients were enrolled in this prospective study, who had received radiation (60-70 Gy) with/without chemotherapy [S-1, UFT, cisplatin (CDDP), docetaxel (DOC) plus CDDP, or Cetuximab]. The Elental® group (25 patients) had received Elental® during treatment, and the control group (25 patients) had not. Multivariate logistic regression analysis was used to identify the factors related to abatement of oral mucositis. A comparison of the rates of completion of chemoradiation treatments as well as the nutritional or inflammatory status between Elental® and control groups was performed. Multivariate analysis indicated that most of the patients who received Elental® suffered from a lower degree of mucositis and showed significantly improved rate of completion of chemoradiation (no interruption) compared to the control group. There was a significant difference between the Elental® group and the control group in terms of the mean change of C-reactive protein (CRP) levels in blood serum; however, there was no significant difference in terms of a mean change of body weight and total protein level in blood serum before and after chemoradiation. Our study shows that the Elental® elemental diet could be useful for the treatment of oral mucositis induced by chemoradiation. Elental® might also promote improved completion rates of chemoradiotherapy in OSCC patients.

Efficacy of elemental diet on prevention for chemoradiotherapy-induced oral mucositis in patients with oral squamous cell carcinoma.

PURPOSE: Oral mucositis induced by radiation or chemoradiation can compromise the quality of life of oral squamous cell carcinoma (OSCC) patients. The present study was designed to evaluate the preventive effects of elemental diet (ED), Elental®, on radiotherapy- or chemoradiotherapy-induced mucositis in OSCC patients. PATIENTS AND METHODS: Seventy-four patients who underwent radiation (60-70 Gy) with/without chemotherapy [S-1, cisplatin (CDDP), CDDP plus S-1] were enrolled in this retrospective study; 37 had received Elental® during treatment (Elental® group) and 37 had not (control group). Factors related to alleviation of oral mucositis were identified by multivariate logistic regression analysis. Rates of completion of chemoradiation treatments were compared between Elental® and control groups according to the treatment regimen. The comparison of the nutritional status between groups was also performed. RESULTS: Multivariate analysis indicated that the administration of Elental® and no combined chemotherapy (radiation alone) were significant factors associated with the degree of oral mucositis, i.e., most of the patients who consumed Elental® suffered from a lower degree of mucositis compared to the control group. Elental® was associated with a significantly improved rate of completion of chemoradiation (no interruption). There was no significant difference between Elental® group and control group in terms of mean change of body weight or total protein and albumin levels in blood serum before and after (chemo)radiation. CONCLUSIONS: The present study indicates that Elental® is effective for ameliorating oral mucositis induced by (chemo)radiation in OSCC patients. Elental® was also associated with improved completion rates of (chemo)radiotherapy.

[Clinical phase I trial of S-1 in the combination with DOC using super-selective intra-arterial infusion with oral cancer].

The super-selective intra-arterial infusion, which has high anti-tumor effect to infuse high concentration of drugs into arterial in the control of tumor, has been expected to have local control. S-1, developed by the scientific theory of both potentiating antitumor activity of 5-fluorouracil(5-FU)and reducing gastrointestinal toxicity induced by 5-FU, is an active agent for squamous cell carcinoma of the head and neck(HNSCC). Docetaxel(DOC)is the drug Taxanes which has anti-tumor effect by mechanism different from conventional anti-tumor mechanism of action. In Yamaguchi University, DOC+CDDP+5-FU in the three-drug combination therapy shows high anti-tumor effect for advanced oral cancer. In the present study, we conducted a phase I study to examine local control of S-1 in the combination with DOC using super-selective intra-arterial infusion with oral cancer. The study performed super-selective intra-arterial infusion of DOC on the first day, and was considered as the schedule which prescribes three-week S-1 for patients every day from same day. Since blood toxicity nature grade 4 discovered the result in S-1: 65 mg/m(2)day and DOC: 50 mg/ m(2), we decided that recommended dose(RD)was S-1: 65 mg/m(2) and DOC: 40 mg/m(2).