Oral mucositis and selective elimination of oral flora in head and neck cancer patients receiving radiotherapy: a double-blind randomised clinical trial

IntroductionOral mucositis is an iatrogenic condition of erythematous inflammatory changes which tends to occur on buccal and labial surfaces, the ventral surface of the tongue, the floor of the mouth and the soft palate of patients receiving chemotherapy. This protocol of ongoing randomised parallel group clinical trial aims to access the therapeutic effect of an herbal gel containing 2.5%Arrabidaea chicaVerlot standardised extract on oral mucositis in patients with head and neck cancer compared with low-level laser therapy.Methods and analysisPatients with head and neck cancer held at Clinics Hospital of University of Campinas, Sao Paulo, who develop early signs/symptoms of oral mucositis are eligible. Baseline characteristics of participants include oral mucositis grade and quality of life assessments. Enrolment started in November 2017 with allocation of patients to one of the study groups by means of randomisation. Patients will be treated either withArrabidaea chicaor laser until wound healing. Monitoring includes daily assessment of mucositis grade and diameter measurement by photographs and millimetre periodontal probe. Treatments will be concluded once mucositis is healed. A blinded assessor will evaluate mucositis cure after referred by the study team. At this point, the gel tube will be weighed to indirectly assess patient’s compliance. At close-out, data will be analysed by a blinded researcher following the procedures described in the statistical analyses.Ethics and disseminationThis clinical trial was approved by the ethics committee of research in humans at the Faculty of Medical Sciences of University of Campinas (report no. 1,613,563/2016). Results from this trial will be communicated in peer-reviewed publications and scientific presentations.Trial registration numberRBR-5×4397.

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

American Journal of Clinical Nutrition ◽

10.1093/ajcn/nqy329 ◽

2019 ◽

Vol 109 (3) ◽

pp. 606-614 ◽

Cited By ~ 4

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.

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Mucositis prevention by selective elimination of oral flora in irradiated head and neck cancer patients

Journal of Oral Pathology and Medicine ◽

10.1111/j.1600-0714.1990.tb00792.x ◽

1990 ◽

Vol 19 (10) ◽

pp. 486-489 ◽

Cited By ~ 40

Author(s):

F. K. L. Spijkervet ◽

H. K. F. Saene ◽

J. J. M. Saene ◽

A. K. Panders ◽

A. Vermey ◽

...

Keyword(s):

Head And Neck Cancer ◽

Head And Neck ◽

Cancer Patients ◽

Neck Cancer ◽

Oral Flora ◽

Selective Elimination

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Randomized Double-Blind, Placebo-Controlled Phase III trial Evaluating the Effect of Oral Glutamine on Radiation-Induced Oral Mucositis and Neck Dermatitis in Head and Neck Cancer Patients

International Journal of Radiation Oncology*Biology*Physics ◽

10.1016/j.ijrobp.2018.07.940 ◽

2018 ◽

Vol 102 (3) ◽

pp. e298

Author(s):

H.H. Lee ◽

C.J. Huang ◽

M.Y. Huang ◽

F. Chen ◽

Y.T. Wang ◽

...

Keyword(s):

Head And Neck Cancer ◽

Head And Neck ◽

Cancer Patients ◽

Neck Cancer ◽

Oral Mucositis ◽

Phase Iii ◽

Double Blind ◽

Phase Iii Trial ◽

Double Blind Placebo ◽

Radiation Induced

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

Reviews on Recent Clinical Trials ◽

10.2174/1574887115666200731182708 ◽

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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Efficacy of the plantago major L. syrup on radiation induced oral mucositis in head and neck cancer patients: A randomized, double blind, placebo-controlled clinical trial

Complementary Therapies in Medicine ◽

10.1016/j.ctim.2020.102397 ◽

2020 ◽

Vol 51 ◽

pp. 102397 ◽

Cited By ~ 1

Author(s):

Gholamreza Mohammad Soltani ◽

Simin Hemati ◽

Mostafa Sarvizadeh ◽

Mohammad Kamalinejad ◽

Vahid Tafazoli ◽

...

Keyword(s):

Clinical Trial ◽

Head And Neck Cancer ◽

Head And Neck ◽

Cancer Patients ◽

Neck Cancer ◽

Controlled Clinical Trial ◽

Plantago Major ◽

Double Blind ◽

Double Blind Placebo ◽

Radiation Induced

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Efficacy and safety of Dentoxol® in the prevention of radiation-induced oral mucositis in head and neck cancer patients (ESDOM): a randomized, multicenter, double-blind, placebo-controlled, phase II trial

Supportive Care in Cancer ◽

10.1007/s00520-020-05358-4 ◽

2020 ◽

Vol 28 (12) ◽

pp. 5871-5879

Author(s):

Rajesh V. Lalla ◽

Sebastián Solé ◽

Sergio Becerra ◽

Claudia Carvajal ◽

Piero Bettoli ◽

...

Keyword(s):

Clinical Trial ◽

Head And Neck Cancer ◽

Head And Neck ◽

Phase Ii ◽

Neck Cancer ◽

Oral Mucositis ◽

Control Group ◽

Efficacy And Safety ◽

Double Blind ◽

Double Blind Placebo

Abstract Purpose The aim of this study was to assess the efficacy and safety of Dentoxol mouthrinse in reducing the severity of oral mucositis (OM) secondary to radiation therapy (RT) for head and neck cancer. Methods A randomized, double-blind, placebo-controlled, multicenter phase II clinical trial was conducted. Subjects were asked to use Dentoxol (n = 55) or control (n = 53) mouthrinse 5 times/day during RT. Twice a week, OM was assessed clinically using the WHO scale and the Oral Mucositis Daily Questionnaire (OMDQ) was completed. Results The incidence of severe OM was 40.7% in the Dentoxol group and 51% in the control group (p = 0.265). Comparing all recorded clinical assessments, severe OM was seen in 13.3% of all assessments in the Dentoxol group vs. 21.8% in the control group (p = 0.000). There was a statistically significant lower proportion of assessments showing severe OM in the Dentoxol group at weeks 4, 5, and 6 of RT. The mean duration of severe OM was 11.95 days in the Dentoxol group vs. 14.59 days in the control group (p = 0.502). There was no difference between groups in mouth pain and its impact on function. The use of Dentoxol was safe and was not linked to any serious adverse events. Conclusion The use of Dentoxol 5 times/day is safe and resulted in significantly fewer time-points with severe OM and a delay in the onset of severe OM, compared with a control rinse. A phase III clinical trial is warranted to confirm efficacy and address the limitations of this study.

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