Tumor Outcomes of Phase IIb, Randomized, Double-Blind Trial of GC4419 Versus Placebo to Reduce Severe Oral Mucositis Due to Concurrent Radiotherapy and Cisplatin For Head and Neck Cancer

2020 ◽  
Vol 106 (5) ◽  
pp. 1221-1222
Author(s):  
C.M. Anderson ◽  
C.M. Lee ◽  
D. Saunders ◽  
A.E. Curtis ◽  
N.E. Dunlap ◽  
...  
Keyword(s):  
Head And Neck Cancer ◽  
Head And Neck ◽  
Neck Cancer ◽  
Oral Mucositis ◽  
Double Blind Trial ◽  
Double Blind ◽  
Blind Trial ◽  
Concurrent Radiotherapy ◽  
Severe Oral Mucositis

scholarly journals Phase IIb, Randomized, Double-Blind Trial of GC4419 Versus Placebo to Reduce Severe Oral Mucositis Due to Concurrent Radiotherapy and Cisplatin For Head and Neck Cancer

2019 ◽  
Vol 37 (34) ◽  
pp. 3256-3265 ◽  
Author(s):  
Carryn M. Anderson ◽  
Christopher M. Lee ◽  
Deborah P. Saunders ◽  
Amarinthia Curtis ◽  
Neal Dunlap ◽  
...  
Keyword(s):  
Head And Neck Cancer ◽  
Head And Neck ◽  
Neck Cancer ◽  
Oral Mucositis ◽  
Phase Iii ◽  
Double Blind Trial ◽  
Double Blind ◽  
Who Grade ◽  
Blind Trial ◽  
To Receive

PURPOSE Oral mucositis (OM) remains a common, debilitating toxicity of radiation therapy (RT) for head and neck cancer. The goal of this phase IIb, multi-institutional, randomized, double-blind trial was to compare the efficacy and safety of GC4419, a superoxide dismutase mimetic, with placebo to reduce the duration, incidence, and severity of severe OM (SOM). PATIENTS AND METHODS A total of 223 patients (from 44 institutions) with locally advanced oral cavity or oropharynx cancer planned to be treated with definitive or postoperative intensity-modulated RT (IMRT; 60 to 72 Gy [≥ 50 Gy to two or more oral sites]) plus cisplatin (weekly or every 3 weeks) were randomly assigned to receive 30 mg (n = 73) or 90 mg (n = 76) of GC4419 or to receive placebo (n = 74) by 60-minute intravenous administration before each IMRT fraction. WHO grade of OM was assessed biweekly during IMRT and then weekly for up to 8 weeks after IMRT. The primary endpoint was duration of SOM tested for each active dose level versus placebo (intent-to-treat population, two-sided α of .05). The National Cancer Institute Common Terminology Criteria for Adverse Events, version 4.03, was used for adverse event grading. RESULTS Baseline patient and tumor characteristics as well as treatment delivery were balanced. With 90 mg GC4419 versus placebo, SOM duration was significantly reduced ( P = .024; median, 1.5 v 19 days). SOM incidence (43% v 65%; P = .009) and severity (grade 4 incidence, 16% v 30%; P = .045) also were improved. Intermediate improvements were seen with the 30-mg dose. Safety was comparable across arms, with no significant GC4419-specific toxicity nor increase of known toxicities of IMRT plus cisplatin. The 2-year follow-up for tumor outcomes is ongoing. CONCLUSION GC4419 at a dose of 90 mg produced a significant, clinically meaningful reduction of SOM duration, incidence, and severity with acceptable safety. A phase III trial (ROMAN; ClinicalTrials.gov identifier: NCT03689712 ) has begun.

scholarly journals Randomized double-blind, placebo-controlled trial evaluating oral glutamine on radiation-induced oral mucositis and dermatitis in head and neck cancer patients

2019 ◽  
Vol 109 (3) ◽  
pp. 606-614 ◽  
Author(s):  
Chih-Jen Huang ◽  
Ming-Yii Huang ◽  
Pen-Tzu Fang ◽  
Frank Chen ◽  
Yu-Tsang Wang ◽  
...  
Keyword(s):  
Head And Neck Cancer ◽  
Head And Neck ◽  
Cancer Patients ◽  
Neck Cancer ◽  
Oral Mucositis ◽  
University Hospital ◽  
Phase Iii ◽  
Care Providers ◽  
Double Blind ◽  
Radiation Induced

ABSTRACT Background Glutamine is the primary fuel for the gastrointestinal epithelium and maintains the mucosal structure. Oncologists frequently encounter oral mucositis, which can cause unplanned breaks in radiotherapy (RT). Objectives The aim of this study was to explore the association between oral glutamine and acute toxicities in patients with head and neck cancer undergoing RT. Methods This was a parallel, double-blind, randomized, placebo-controlled Phase III trial conducted in a university hospital. A central randomization center used computer-generated tables to allocate interventions to 71 patients with stages I–IV head and neck cancers. The patients, care providers, and investigators were blinded to the group assignment. Eligible patients received either oral glutamine (5 g glutamine and 10 g maltodextrin) or placebo (15 g maltodextrin) 3 times daily from 7 d before RT to 14 d after RT. The primary and secondary endpoints were radiation-induced oral mucositis and neck dermatitis, respectively. These were documented in agreement with the National Cancer Institute Common Terminology Criteria for Adverse Events version 3. Results The study included 64 patients (placebo n = 33; glutamine n = 31) who completed RT for the completers’ analysis. Based on multivariate analysis, glutamine had no significant effect on the severity of oral mucositis (OR: 0.3; 95% CI: 0.05, 1.67; P = 0.169). Only the change in body mass index (BMI) was significant in both multivariate completers (OR: 0.41; 95% CI: 0.20, 0.84; P = 0.015) and per-protocol analysis (OR: 0.40; 95% CI: 0.20, 0.83; P = 0.014). No difference was found in the incidence and severity of neck dermatitis between the two arms. Conclusions The decrease in BMI was strongly related to the severity of oral mucositis in the head and neck cancer patients under RT, but not to the use of glutamine. This trial was registered at clinicaltrials.gov as NCT03015077.

Radiation Induced Oral Mucositis in Head and Neck Cancer Patients. Is There Any Effective Management? Review of the Literature the Last Five Years.

2020 ◽  
Vol 15 ◽  
Author(s):  
Areti Gkantaifi ◽  
Emmanouil Vardas ◽  
Filippo Alongi ◽  
Nikolaos Tsoukalas ◽  
Haytham Hamed Saraireh ◽  
...  
Keyword(s):  
Head And Neck Cancer ◽  
Head And Neck ◽  
Cancer Patients ◽  
Neck Cancer ◽  
Oral Mucositis ◽  
Double Blind ◽  
Regular Treatment ◽  
Natural Agents ◽  
Pubmed Database ◽  
Radiation Induced

Backround: Radiation induced oral mucositis consists of a series of relatively frequent side effects after head and neck cancer radiotherapy and has an adverse impact on both regular treatment process and the quality of life of patients. Objective: The purpose of the present review is to optimize the current management of radiation induced oral mucositis in head and neck cancer patients. Methods: PubMed database research was performed on articles published since 2015 that demonstrated efficacy in the management of radiation induced oral mucositis in head and neck cancer patients.The study selection included observa-tional, prospective, comparative, randomized, double-blind, placebo-controlled or uncontrolled, and retrospective studies, as well as systematic reviews and metanalyses. Results: From the 931 citations of our search only 94 articles met our inclusion criteria including mucosal protectants, anti-inflammatory agents, growth factors, and various miscellaneous and natural agents. Several methods including both pharmacological and natural agents have been proposed for the management of oral mucositis. In addition to the already known interventions with high evidence, according to Multinational Association of Supportive Care in Cancer and International Society of Oral Oncology guidelines, further agents have been used. However, a great number of them are lacking of clear evidence, which surely requires the design of more controlled clinical trials for the better assessment of the most ideal methods. Conclusion: The management of oral mucositis constitutes an active area of research. In the light of our results we aim to illustrate those treatment strategies that are most effective regarding the treatment approach of oral mucositis.

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