Efficacy and safety of rebamipide liquid for chemoradiotherapy-induced oral mucositis in patients with head and neck cancer: a multicenter, randomized, double-blind, placebo-controlled, parallel-group phase II study

Yokota, Tomoya; Ogawa, Takenori; Takahashi, Shunji; Okami, Kenji; Fujii, Takashi; Tanaka, Kaoru; Iwae, Shigemichi; Ota, Ichiro; Ueda, Tsutomu; Monden, Nobuya; Matsuura, Kazuto; Kojima, Hiromi; Ueda, Shinya; Sasaki, Keita; Fujimoto, Yasushi; Hasegawa, Yasuhisa; Beppu, Teruhiko; Nishimori, Hisakazu; Hirano, Shigeu; Naka, Yoshiharu; Matsushima, Yuki; Fujisawa, Masato; Tahara, Makoto

doi:10.1186/s12885-017-3295-4

Cited by 26 publications

(22 citation statements)

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“…Taxanes, platinum-containing drugs, and FUs are all reported to cause mucosal damage, with an incidence of up to 70% [ 11 , 12 ]. However, several countermeasures to prevent OM with chemo(radio)therapy have been reported [ 13 – 15 ], those effects might not be sufficient for multidrug anticancer agents. A report indicated that the oral glutamine (Gln) administration reduced the duration and severity of OM after cytotoxic cancer chemotherapy.…”

Section: Introductionmentioning

confidence: 99%

The effect of an elemental diet on oral mucositis of esophageal cancer patients treated with DCF chemotherapy: a multi-center prospective feasibility study (EPOC study)

Tanaka

Ueno²,

Yoshida

et al. 2018

Esophagus

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PurposeOral mucositis (OM) is one of the most uncomfortable adverse events experienced by cancer patients undergoing chemotherapy. Previous reports have revealed that the oral administration of an elemental diet (ED) may prevent OM. However, the incidence of OM has not been accurately determined by specialized diagnostic methods and the effects of an ED on OM remain unclear. We investigated the dose that could feasibly be administered and its effects with regard to the suppression of OM in esophageal cancer patients undergoing chemotherapy.MethodsWe performed a prospective multi-center feasibility study of the administration of an ED (160 g/day) with 2 cycles of docetaxel/cisplatin/5-FU (DCF) chemotherapy. We assessed compliance to the ED for 49 days and the incidence of OM according to the amount of the ED that was orally administered. The incidence of OM was graded by a dental specialist who was experienced in dental oncology using a central OM review system.ResultsFourteen of 20 patients (70%) were able to complete the orally administered ED (160 g/day) during the course of chemotherapy. Three patients (15%) could not take the ED orally for 9, 14, and 21 days, respectively, while 1 patient (5%) took the ED orally at an average dose of 80 g/day for 35 days. The remaining 2 patients (10%) could not take the 80 g/day dose for 11 and 12 days, respectively. The incidence of grade ≥ 2 OM in the ED completion group (15.4%, 2 of 13 patients) was significantly lower than that in the non-completion group (66.7%, 4 of 6 patients) (p = 0.046).ConclusionsAn ED might be a one of the test treatment to reduce the incidence of OM in esophageal cancer patients treated with DCF and should be evaluated in further randomized study.Clinical trialThe date of submission: Dec 08th, 2017.Electronic supplementary materialThe online version of this article (10.1007/s10388-018-0620-1) contains supplementary material, which is available to authorized users.

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Section: Introductionmentioning

confidence: 99%

The effect of an elemental diet on oral mucositis of esophageal cancer patients treated with DCF chemotherapy: a multi-center prospective feasibility study (EPOC study)

Tanaka

Ueno²,

Yoshida

et al. 2018

Esophagus

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“…The design of the original trial (a multicenter, randomized, double-blind, placebo-controlled, dose-ranging, phase 2 trial; ClinicalTrials.gov identifier: NCT02085460) has been already published in detail [ 13 ]. Briefly, patients with histopathological diagnosis of primary tumor scheduled to undergo definitive or postoperative CRT to head and/or neck were eligible for enrollment.…”

Section: Methodsmentioning

confidence: 99%

“…We employed the incidence of severe OM in clinical examination determined by INV to compare with the incidence of severe OM in clinical examination determined by ICR, and determined the difference in evaluations scored between ICR and INV, the primary end point of the current post hoc study. The difference in the incidences of severe OM (grade ≥ 3) between the respective groups was evaluated through Chi square test [ 13 ].…”

Section: Methodsmentioning

confidence: 99%

“…Based on mucus protective action of rebamipide [ 9 – 11 ], one of the treatments for gastritis and gastric ulcer [ 12 ], the phase 2 exploring trial had evaluated the preventive effect of rebamipide liquid on CRT-induced OM in patients with HNC, and the result demonstrated a potential availability of rebamipide against the incidence of severe OM [ 13 ].…”

Section: Introductionmentioning

confidence: 99%

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The post hoc analysis comparing the severity grades of chemoradiotherapy-induced oral mucositis scored between the central and local assessors in a multicenter, randomized controlled trial of rebamipide for head and neck cancer

Ueno¹,

Zenda

Konishi

et al. 2018

Int J Clin Oncol

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Background In the treatment of head and neck cancer, severity of chemoradiotherapy-induced oral mucositis has been recognized as one of the key factors affecting the outcomes of the anticancer therapies. Therefore, the development of treatments mitigating oral mucositis would be of clinical significance, although the adequate assessment procedure for efficacy evaluation remains to be established. We conducted this post hoc study to assess the effect of objective evaluation of the severity grade on the outcomes of the clinical trial. Methods In the original trial with rebamipide liquids (0, 2, and 4%) for chemoradiotherapy-induced oral mucositis, the investigators in local sites and independent central review separately determined the severity grades in accordance with Common Terminology Criteria of Adverse Events version 3.0 based on the Assessment Sheet scored by the investigators. The discordance in severity grades between the investigators and central review was analyzed on cross table. Results The analysis revealed the discordance rate over the trial was 34%. While the incidences of severe oral mucositis in the placebo, rebamipide 2%, and 4% groups evaluated by the central review were 39%, 29%, and 25%, respectively, the respective values in the investigator’s evaluation were 32%, 39%, and 44%. Conclusion In the clinical trial for the treatment of oral mucositis, it was strongly suggested that objective evaluation with a consistent scale would be required. Electronic supplementary material The online version of this article (10.1007/s10147-018-1355-7) contains supplementary material, which is available to authorized users.

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“…Oral cryotherapy prevented stomatitis in patients receiving bolus doses of 5-fluorouracil and haematopoietic stem cell transplantation 5. Rebamipide is an internal-use mucosal protectant, and gargling with rebamipide has been reported to prevent stomatitis in patients with head and neck cancer who are receiving chemoradiotherapy 6 7. However, recommendations for preventing chemotherapy-induced stomatitis in patients with breast cancer are lacking.…”

Section: Introductionmentioning

confidence: 99%

Study protocol for efficacy and safety of steroid-containing mouthwash to prevent chemotherapy-induced stomatitis in women with breast cancer: a multicentre, open-label, randomised phase 2 study

et al. 2020

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IntroductionStomatitis is a frequent adverse event in patients undergoing chemotherapy for breast cancer. Stomatitis can hamper oral nutrition resulting in malnutrition, reduce quality of life and introduce the need for dose reductions and interruption of chemotherapy; however, there is currently no standard approach for preventing chemotherapy-induced stomatitis. We aimed to assess the safety and efficacy of a dexamethasone-based elixir mouthwash for preventing chemotherapy-induced stomatitis in patients with early breast cancer.Methods and analysisIn this multicenter, randomised, controlled phase 2 trial, we will randomly assign 120 women with early breast cancer undergoing chemotherapy to use of a dexamethasone-based elixir or standard oral care, to compare their preventive effects on chemotherapy-induced stomatitis. Patients will be assigned in a 1:1 ratio. Patients in the intervention group will receive chemotherapy, oral care and a dexamethasone-based elixir (10 mL 0.1 mg/mL; swish for 2 min and spit, four times daily for 9 weeks), and patients in the control group will receive chemotherapy and oral care. The primary endpoint is the difference in incidence of stomatitis between the two groups. The sample size allows for the detection of a minimum difference of 20% in the incidence of stomatitis between the two groups. Secondary endpoints are severity of stomatitis, duration of stomatitis, completion rate of chemotherapy and adverse events.Ethics and disseminationAll participants signed a written consent form, and the study protocol has been reviewed and approved by the Clinical Research Review Board of Nagasaki University (CRB7180001).Trial registration numberUMIN Clinical Trials Registry (UMIN000030489).

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Efficacy and safety of rebamipide liquid for chemoradiotherapy-induced oral mucositis in patients with head and neck cancer: a multicenter, randomized, double-blind, placebo-controlled, parallel-group phase II study

Cited by 26 publications

References 13 publications

The effect of an elemental diet on oral mucositis of esophageal cancer patients treated with DCF chemotherapy: a multi-center prospective feasibility study (EPOC study)

The effect of an elemental diet on oral mucositis of esophageal cancer patients treated with DCF chemotherapy: a multi-center prospective feasibility study (EPOC study)

The post hoc analysis comparing the severity grades of chemoradiotherapy-induced oral mucositis scored between the central and local assessors in a multicenter, randomized controlled trial of rebamipide for head and neck cancer

Study protocol for efficacy and safety of steroid-containing mouthwash to prevent chemotherapy-induced stomatitis in women with breast cancer: a multicentre, open-label, randomised phase 2 study

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