Randomized, Double-Blind, Placebo-Controlled Trial of Shuanghua Baihe Tablets to Prevent Oral Mucositis in Patients With Nasopharyngeal Cancer Undergoing Chemoradiation Therapy

Zheng, Bingna; Zhu, Xiaodong; Liu, Mengzhong; Yang, Zhenzhou; Yang, Ling; Lang, Jinyi; Shi, Mei; Wu, Gang; He, Xia; Chen, Xiaozhong; Xi, Xuping; Zhao, Dan; Zhu, Guangying

doi:10.1016/j.ijrobp.2017.10.013

Cited by 25 publications

(54 citation statements)

References 35 publications

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“…The reported incidence of severe OM after receiving chemoradiotherapy in NPC is at 70-80% (24). Assuming that an average incidence of OM in the placebo and probiotics groups was at 74% and 34%, respectively, 70 patients were enrolled to ensure statistical significance (twosided α = 0.05, 1-β = 0.9 and 1:1 ratio).…”

Section: Discussionmentioning

confidence: 99%

A Phase II Randomized Clinical Trial and Mechanistic Studies Using Improved Probiotics to Prevent Oral Mucositis Induced by Concurrent Radiotherapy and Chemotherapy in Nasopharyngeal Carcinoma

Xia

Jiang

et al. 2021

Front. Immunol.

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Earlier evidence has proven that probiotic supplements can reduce concurrent chemoradiotherapy (CCRT)-induced oral mucositis (OM) in nasopharyngeal cancer (NPC). The incidence of severe OM (grade 3 or higher) was the primary endpoint in this study. We first enrolled 85 patients with locally advanced NPC who were undergoing CCRT. Of them, 77 patients were finally selected and randomized (1:1) to receive either a probiotic cocktail or placebo. To investigate the protective effects and the mechanism of probiotic cocktail treatment on OM induced by radiotherapy and chemotherapy, we randomly divided the rats into the control (C) group, the model (M) group, and the probiotic (P) group. After treatment, samples from the tongue, blood, and fecal and proximal colon tissues on various days (7th, 14th, and 21st days) were collected and tested for the inflammatory response, cell apoptosis, intestinal permeability, and intestinal microbial changes. We found that patients taking the probiotic cocktail showed significantly lower OM. The values of the incidence of 0, 1, 2, 3, and 4 grades of OM in the placebo group and in the probiotic cocktail group were reported to be 0, 14.7, 38.2, 32.4, and 14.7% and 13.9, 36.1, 25, 22.2, and 2.8%, respectively. Furthermore, patients in the probiotic cocktail group showed a decrease in the reduction rate of CD3+ T cells (75.5% vs. 81%, p < 0.01), CD4+ T cells (64.53% vs. 79.53%, p < 0.01), and CD8+ T cells (75.59 vs. 62.36%, p < 0.01) compared to the placebo group. In the rat model, the probiotic cocktail could ameliorate the severity of OM, decrease the inflammatory response, cause cell apoptosis and intestinal permeability, and restore the structure of gut microbiota to normalcy. In conclusion, the modified probiotic cocktail significantly reduces the severity of OM by enhancing the immune response of patients with NPC and modifying the structure of gut microbiota.Clinical Trial Registration: The Clinical Trial Registration should be the NCT03112837.

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Section: Discussionmentioning

confidence: 99%

A Phase II Randomized Clinical Trial and Mechanistic Studies Using Improved Probiotics to Prevent Oral Mucositis Induced by Concurrent Radiotherapy and Chemotherapy in Nasopharyngeal Carcinoma

Xia

Jiang

et al. 2021

Front. Immunol.

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“…At present, there is not any kind of good method to control the OM pain, commonly used analgesics are local anesthetic drugs, such as lidocaine mouthwash. It has been reported that Chinese shuanghuabaihe tablets can reduce the occurrence and severity of OM of NPC patients undergoing CCRT [13]. Similarly, kangfuxin solution also reported acceptable for clinical application in NPC patients [12].…”

Section: Discussionmentioning

confidence: 99%

“…Currently, the primary strategies for preventing or reducing OM pain include nutritional supplementation, oral cleaning, promotion of local mucosal recovery, and use of antibiotics and analgesics [8, 11–13]. Commonly used analgesics are local anesthetic drugs, such as lidocaine mouthwash.…”

Section: Introductionmentioning

confidence: 99%

Efficacy of controlled-release oxycodone for reducing pain due to oral mucositis in nasopharyngeal carcinoma patients treated with concurrent chemoradiotherapy: a prospective clinical trial

Hua

Chen

Zhu

et al. 2019

Support Care Cancer

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Background Pain due to oral mucositis (OM) is a major problem during concurrent chemoradiotherapy (CCRT) in nasopharyngeal carcinoma (NPC) patients. Methods We enrolled 56 NPC patients receiving CCRT and allocated them into two groups: moderate pain group ( n = 27) and a severe pain group ( n = 29) according to the degree of pain reported (moderate = numerical rating scale (NRS) score 4–6 or severe = NRS score 7–10) at initiation of controlled-release oxycodone (CRO) treatment. Results Total dose of CRO was significantly higher in severe pain patients than in moderate pain patients (791.60 ± 332.449 mg vs. 587.27 ± 194.940 mg; P = 0.015). Moderate pain patients had significantly better quality of life ( P = 0.037), lower weight loss ( P = 0.030) and more active CCRT response (90.9% vs. 64.0%; P = 0.041). Although 24-h pain control rate was comparable in the two groups (85.2% vs. 86.2%; P = 0.508), the moderate pain group score eventually stabilized at ~ 2 vs. 3 in the severe pain group ( P < 0.001); the titration time to reach bearable pain (NRS ≤ 3) was also significantly shorter in moderate pain patients (2.45 ± 0.60 days vs. 3.60 ± 1.98 days; P = 0.012). Incidence of adverse events was comparable in both groups. Conclusions The study findings suggest that early introduction of low-dose CRO at the moderate pain stage could help reduce the total dose required, provide better pain control, improve quality of life, and enhance CCRT response.

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“…On the basis of the hypothesis that the average incidence of severe OM (grade 3 or higher) in the placebo group and the probiotic combination group would be 74% and 34%, respectively, 70 patients were needed (2‐sided α = .05, 1 – β = 0.9, and 2:1 ratio). We recruited 99 patients, who were randomly assigned, to provide more than adequate power to detect clinically significant differences, and the Fisher exact test was used to evaluate the incidence of different degrees of OM.…”

Section: Methodsmentioning

confidence: 99%

A randomized, double‐blind, placebo‐controlled trial of probiotics to reduce the severity of oral mucositis induced by chemoradiotherapy for patients with nasopharyngeal carcinoma

Jiang

Wang

Xia

et al. 2018

Cancer

122

118

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BACKGROUND:The objective of this study was to evaluate the effect of a probiotic combination on the severity of oral mucositis (OM), which is a common, unpreventable complication induced by radiochemotherapy in patients with nasopharyngeal carcinoma who undergo concurrent radiochemotherapy (CCRT). METHODS: Eligible patients (n = 99) with locally advanced nasopharyngeal carcinoma who were undergoing CCRT were randomly assigned (2:1) to receive a probiotic combination or placebo during radiochemotherapy, and the incidence of severe OM (grade 3 or higher) was the primary endpoint. RESULTS: Patients taking the probiotic combination showed a significant reduction in the severity of OM. The incidences of grade 0, 1, 2, and 3 OM in the placebo group and the probiotic combination group were 0% and 12.07%, 0% and 55.17%, 54.29% and 17.24%, and 45.71% and 15.52%, respectively. Furthermore, CCRT greatly lowered the number of immune cells, whereas the probiotic combination markedly lowered the reduction rates of CD4 + T cells (76.59% vs 52.85%; P < .05), CD8 + T cells (62.94% vs 29.76%; P < .05), and CD3 + T cells (69.72% vs 45.49%; P < .05) in an A-CCRT-P (after treatment with radiotherapy plus chemotherapy plus the probiotic combination) group. Highthroughput sequencing results indicated that CCRT had obviously disturbed the intestinal diversity of patients in an A-CCRT (after treatment with radiotherapy plus chemotherapy plus a placebo) group, whereas the probiotic combination distinctly restored the microbial diversity in the A-CCRT-P group toward that of healthy people and a B-CCRT-P (before the treatment of radiotherapy plus chemotherapy plus the probiotic combination) group. CONCLUSIONS: A probiotic combination significantly enhances the immune response of patients and reduces the severity of OM through modification of gut microbiota.

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Randomized, Double-Blind, Placebo-Controlled Trial of Shuanghua Baihe Tablets to Prevent Oral Mucositis in Patients With Nasopharyngeal Cancer Undergoing Chemoradiation Therapy

Cited by 25 publications

References 35 publications

A Phase II Randomized Clinical Trial and Mechanistic Studies Using Improved Probiotics to Prevent Oral Mucositis Induced by Concurrent Radiotherapy and Chemotherapy in Nasopharyngeal Carcinoma

A Phase II Randomized Clinical Trial and Mechanistic Studies Using Improved Probiotics to Prevent Oral Mucositis Induced by Concurrent Radiotherapy and Chemotherapy in Nasopharyngeal Carcinoma

Efficacy of controlled-release oxycodone for reducing pain due to oral mucositis in nasopharyngeal carcinoma patients treated with concurrent chemoradiotherapy: a prospective clinical trial

A randomized, double‐blind, placebo‐controlled trial of probiotics to reduce the severity of oral mucositis induced by chemoradiotherapy for patients with nasopharyngeal carcinoma

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