CHITOSAN IN THE TREATMENT OF RADIOTHERAPY INDUCED ORAL MUCOSITIS IN HEAD AND NECK CANCER PATIENTS: A RANDOMISD CLINICAL TRIAL

2017 ◽  
Vol 124 (3) ◽  
pp. e198-e199
Author(s):  
ARVIND MUTHUKRISHNAN ◽  
G. SHANMUGHAPRIYA
Keyword(s):  
Clinical Trial ◽  
Head And Neck Cancer ◽  
Head And Neck ◽  
Cancer Patients ◽  
Neck Cancer ◽  
Oral Mucositis

scholarly journals Arrabidaea chicafor oral mucositis in patients with head and neck cancer: a protocol of a randomised clinical trial

BMJ Open ◽  
2018 ◽  
Vol 8 (10) ◽  
pp. e019505
Author(s):  
Núbia de Cassia Almeida Queiroz ◽  
Michelle Pedroza Jorge ◽  
Ilza Maria de Oliveira Sousa ◽  
Carmen Silvia Passos Lima ◽  
Maria Christina de Miranda Matias ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Head And Neck Cancer ◽  
Head And Neck ◽  
Neck Cancer ◽  
Oral Mucositis ◽  
Study Groups ◽  
Randomised Clinical Trial ◽  
Ventral Surface ◽  
Low Level Laser Therapy ◽  
Arrabidaea Chica

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.

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.

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