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

2018 ◽  
Vol 100 (2) ◽  
pp. 418-426 ◽  
Author(s):  
Baomin Zheng ◽  
Xiaodong Zhu ◽  
Mengzhong Liu ◽  
Zhenzhou Yang ◽  
Ling Yang ◽  
...  
Keyword(s):  
Oral Mucositis ◽  
Controlled Trial ◽  
Nasopharyngeal Cancer ◽  
Chemoradiation Therapy ◽  
Double Blind ◽  
Double Blind Placebo

Randomized double-blind placebo-controlled trial of celecoxib for radiation-induced oral mucositis.

2013 ◽  
Vol 31 (15_suppl) ◽  
pp. 9620-9620
Author(s):  
Rajesh V. Lalla ◽  
Linda E. Choquette ◽  
Kathleen F. Curley ◽  
Robert J. Dowsett ◽  
Richard S. Feinn ◽  
...  
Keyword(s):  
Oral Mucositis ◽  
Fixed Effects ◽  
Controlled Trial ◽  
Opioid Analgesics ◽  
T Test ◽  
Double Blind ◽  
Double Blind Placebo ◽  
Pain Scores ◽  
Significant Difference ◽  
Cox 2

9620 Background: Oral mucositis (OM) is a painful complication of radiation therapy (RT) for head and neck (H&N) cancer. OM can compromise nutrition, require opioid analgesics and hospitalization for pain control, and lead to treatment interruptions. Due to the role of inflammatory pathways in the pathogenesis of OM, this study investigated the effect of inhibition of cyclooxygenase-2 (COX-2) on severity and morbidity of OM. Methods: In this randomized double-blind placebo-controlled trial,40 H&N cancer patients were randomized to daily use of 200 mg celecoxib or matched placebo, for the duration of RT. Eligibility criteria included planned RT dose of ≥ 5000 cGy to 2+ areas of the mouth and no contraindication for celecoxib use. The planned sample size of 20 per arm provided 80% power to detect a 1 point difference in mean Oral Mucositis Assessment Scale (OMAS) score (range 0-5) at 5000 cGy RT (primary endpoint), applying a two-tailed, two-sample t-test at the 5% level of significance. Clinical OM, normalcy of diet, pain scores and analgesic use were assessed 2-3 times a week by blinded investigators during the 6-7 week period of RT, using validated scales. Results: Twenty subjects were randomized to each arm, which were similar with respect to tumor location, radiation dose, and concomitant chemotherapy. In both arms, mucositis and pain scores increased over the course of RT. Intent-to-treat analyses demonstrated no significant difference in mean (SD) OMAS scores at 5000 cGy [celecoxib 1.32 (0.71), placebo 1.27 (0.86), p = 0.83, two sample t-test]. There was also no difference between the celecoxib and placebo arms respectively, in mean OMAS scores over the period of RT (SD) [0.98(0.77) & 0.97 (0.86), p = 0.84], mean worst pain scores [3.38 (3.07) & 3.31 (3.32), p = 0.83], mean normalcy of diet scores [5.43 (3.86) & 5.11(3.94), p = 0.65], or mean daily opioid medication use in IV morphine equivalents [19.08 (16.57) & 20.48 (19.07), p = 0.48], all by linear mixed model fixed effects regression analysis. There were no SAEs attributed to celecoxib use. Conclusions: Daily use of a selective COX-2 inhibitor, during the period of RT for H&N cancer, did not reduce the severity of clinical OM, pain, dietary compromise or use of opioid analgesics. Clinical trial information: NCT00698204.

A randomized, double-blind, placebo-controlled trial of misoprostol for oral mucositis secondary to high-dose chemotherapy

2011 ◽  
Vol 20 (8) ◽  
pp. 1797-1804 ◽  
Author(s):  
Rajesh V. Lalla ◽  
Gary B. Gordon ◽  
Mark Schubert ◽  
Sol Silverman ◽  
Mark Hutten ◽  
...  
Keyword(s):  
Oral Mucositis ◽  
Controlled Trial ◽  
High Dose Chemotherapy ◽  
High Dose ◽  
Double Blind ◽  
Double Blind Placebo

scholarly journals Ketamine mouthwash versus placebo in the treatment of severe oral mucositis pain in children with cancer: A randomized double‐blind placebo‐controlled trial

2020 ◽  
Vol 67 (9) ◽  
Author(s):  
Satya Prakash ◽  
Jagdish Prasad Meena ◽  
Aditya Kumar Gupta ◽  
Sameer Bakhshi ◽  
Thirumurthy Velpandian ◽  
...  
Keyword(s):  
Oral Mucositis ◽  
Controlled Trial ◽  
Children With Cancer ◽  
Double Blind ◽  
Double Blind Placebo ◽  
Severe Oral Mucositis

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

Cancer ◽  
2018 ◽  
Vol 125 (7) ◽  
pp. 1081-1090 ◽  
Author(s):  
Chunling Jiang ◽  
Huan Wang ◽  
Chaofei Xia ◽  
Qing Dong ◽  
En Chen ◽  
...  
Keyword(s):  
Nasopharyngeal Carcinoma ◽  
Oral Mucositis ◽  
Controlled Trial ◽  
Double Blind ◽  
Double Blind Placebo

Efficacy of gabapentin mouthwash in managing oral mucositis pain in patients undergoing chemotherapy: a prospective, randomised, double-blind, controlled clinical trial

2020 ◽  
Vol 65 (1) ◽  
pp. 12-18
Author(s):  
Shahram Ala ◽  
Neda Zamani ◽  
Jafar Akbari ◽  
Ebrahim Salehifar ◽  
Ghasem Janbabai ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Pain Intensity ◽  
Oral Mucositis ◽  
Controlled Trial ◽  
Sufficient Evidence ◽  
Controlled Clinical Trial ◽  
Significant Activity ◽  
Double Blind ◽  
Double Blind Placebo ◽  
Significant Difference

Background and aims Gabapentin has been used for the management of radiotherapy and chemotherapy induced stomatitis in a number of studies. Due to lack of sufficient evidence, the present study was designed to evaluate the efficacy of gabapentin mouthwash in oral mucositis associated pain in patients undergoing cancer chemotherapy. Methods and results This study was a prospective, randomised, double-blind, placebo-controlled trial. The patients were randomly divided into two groups receiving either the gabapentin or placebo mouthwash. Patients were advised to rinse their mouth with 7 ml of solution for 30 s three times a day and were visited 10 days after initiation of the trial. The intensity of pain and severity of oral mucositis were assessed. Thirty-one patients received gabapentin mouthwash while 27 patients received placebo. Both gabapentin and placebo mouthwashes had decreased the pain intensity almost equally and did not show a significant difference between the two groups (P = 0.73). Also both gabapentin and placebo had reduced and improved swallowing, inflammation and erythema. But there was no noticeable difference between groups (P > 0.05). Conclusions These findings indicate that gabapentin mouthwash did not show a significant activity as a pain relieving agent in chemotherapy induced oral mucositis associated pain.

scholarly journals Randomized double-blind placebo-controlled trial of celecoxib for oral mucositis in patients receiving radiation therapy for head and neck cancer

Oral Oncology ◽  
2014 ◽  
Vol 50 (11) ◽  
pp. 1098-1103 ◽  
Author(s):  
Rajesh V. Lalla ◽  
Linda E. Choquette ◽  
Kathleen F. Curley ◽  
Robert J. Dowsett ◽  
Richard S. Feinn ◽  
...  
Keyword(s):  
Radiation Therapy ◽  
Head And Neck Cancer ◽  
Head And Neck ◽  
Neck Cancer ◽  
Oral Mucositis ◽  
Controlled Trial ◽  
Double Blind ◽  
Double Blind Placebo
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