A Randomized, Double-Blind, Placebo-Controlled, Cross-Over Study to Evaluate the Efficacy of AqualiefTM Mucoadhesive Tablets in Head and Neck Cancer Patients Who Developed Radiation-Induced Xerostomia

Xerostomia, the subjective complaint of dry mouth, is caused by therapeutic interventions or diseases. Nowadays, radiotherapy (RT) in patients with head and neck cancer (HNC) stands out as one of the most important causes of xerostomia. Currently available therapies for the treatment of xerostomia are still less than optimal and xerostomia still represents an unmet clinical need. In this article, we present the results of a prospective clinical study with a new product, AqualiefTM, in patients treated with curative RT with or without chemotherapy for HNC. AqualiefTM is based on two main ingredients, carnosine and karkadé, which have acid buffering and antioxidant properties. The study was performed on 30 patients, with 4 of the patients being lost during the study period. Each patient received randomly one of the two treatments, AqualiefTM or placebo, for 8 days. After a 10-day wash-out period, each patient received the other treatment for a further 8 days. The results show that AqualiefTM stimulated salivation in these patients and reduced the pH drop that was observed in an equivalent placebo-treated population of patients. Moreover, no serious, treatment-related adverse events were observed. AqualiefTM has shown positive results, although with limitations due to unsuccessful trial accrual. Therefore, it may be further investigated as a tool for the treatment of RT-related xerostomia.

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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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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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