Dataset Information

A Bioadhesive Barrier-Forming Oral Liquid Gel Improved Oral Mucositis and Nutritional Status in Patients With Head and Neck Cancers Undergoing Radiotherapy: A Retrospective Single Center Study.

ABSTRACT:

Background

Episil^® is a bioadhesive barrier-forming oral liquid gel that can relieve oral mucositis (OM) caused by radiotherapy (RT) and hence relieves pain effectively. In this study, we observed the effects of Episil^® on the OM and nutritional status of patients with head and neck cancers (HNCs) undergoing RT.

Methods

A total of 50 HNC patients were divided into the Episil^® (25 patients) and control (25 patients) groups. Patients in the Episil^® group were sprayed with Episil^®. In the control group, the kangfuxin solution or Kangsu™ oral gargle was used. Medical staff assessed the OM extent and timing as well as the nutritional status during treatment and recorded adverse reactions other than OM. The nutritional status assessment included the following indicators: Patient Generated-Subjective Global Assessment (PG-SGA) score, body mass index (BMI), body weight, albumin levels, and other hematological indicators.

Results

The incidence of high-level OM (III-IV) after RT was lower in the Episil^® group than in the control group (P < 0.05). Nutritional status assessments showed that the Episil^® group had a lower percentage of weight loss than the control group at weeks 4 and 7 after RT. Similar results were also obtained for BMI and albumin levels (P < 0.05). Moreover, according to PG-SGA scores, fewer patients in the Episil^® group were malnourished and more patients were well-nourished (P < 0.05) compared with the control group.

Conclusion

Episil^® effectively improved OM and malnutrition in HNC patients who received RT and has a good clinical application value.

SUBMITTER: Wei J

PROVIDER: S-EPMC7937867 | biostudies-literature | 2021

REPOSITORIES: biostudies-literature

ACCESS DATA

Publications

A Bioadhesive Barrier-Forming Oral Liquid Gel Improved Oral Mucositis and Nutritional Status in Patients With Head and Neck Cancers Undergoing Radiotherapy: A Retrospective Single Center Study.

Wei Jinlong J Wu Jie J Wang Huanhuan H Wang Bin B Zhao Tingting T Meng Lingbin L Dong Lihua L Jiang Xin X

Frontiers in oncology 20210222

<h4>Background</h4>Episil<sup>®</sup> is a bioadhesive barrier-forming oral liquid gel that can relieve oral mucositis (OM) caused by radiotherapy (RT) and hence relieves pain effectively. In this study, we observed the effects of Episil<sup>®</sup> on the OM and nutritional status of patients with head and neck cancers (HNCs) undergoing RT.<h4>Methods</h4>A total of 50 HNC patients were divided into the Episil<sup>®</sup> (25 patients) and control (25 patients) groups. Patients in the Episil<su ...[more]

PMID: 33692954

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Project description:ObjectiveThere is limited evidence regarding the economic effects of nutrition support in cancer patients. This study aims at investigating the cost-effectiveness profile of systematic oral nutritional supplementation (ONS) in head and neck cancer (HNC) patients undergoing radiotherapy (RT) and receiving nutritional counseling.MethodsA cost-effectiveness analysis based on a RCT was performed to estimate direct medical costs, life years gained (LYG) and Quality-Adjusted Life Years (QALY) for nutritional counseling with or without ONS at 5-month and 6-year follow up time. Value of information analysis was performed to value the expected gain from reducing uncertainty through further data collection.ResultsONS with nutritional counseling produced higher QALY than nutritional counseling alone (0.291 ± 0.087 vs 0.288 ± 0.087), however the difference was not significant (0.0027, P = 0.84). Mean costs were €987.60 vs €996.09, respectively in the treatment and control group (-€8.96, P = 0.98). The Incremental Cost Effectiveness Ratio (ICER) was -€3,277/QALY, with 55.4% probabilities of being cost-effective at a cost-effectiveness threshold of €30,000/QALY. The Expected Incremental Benefit was €95.16 and the Population Expected Value of Perfect Information was €8.6 million, implying that additional research is likely to be worthwhile. At a median 6-year follow up, the treatment group had a significantly better survival rate when adjusting for late effect (P = 0.039).ConclusionOur findings provide the first evidence to inform decisions about funding and reimbursement of ONS in combination with nutritional counseling in HNC patients undergoing RT. ONS may improve quality of cancer care at no additional costs, however further research on the cost-effectiveness of nutritional supplementation is recommended.Trial registrationClinicalTrials.gov: NCT02055833. Registered 5th February 2014 https://clinicaltrials.gov/ct2/show/NCT02055833.

Project description:Background: Locally advanced head and neck cancer is managed either by combined surgery and (chemo) radiotherapy or definitive (chemo) radiotherapy, which may deteriorate nutritional status. Previous data have shown that intensive nutritional intervention by a dietician reduces radiation-induced adverse events including weight loss. Objective: To determine if on-demand nutritional counseling (ODC, control group) would be as efficacious as intensive nutritional counseling (INC, experimental group) in patients undergoing (chemo) radiotherapy. Methods: Fifty-eight patients were randomly assigned to receive INC (n = 26) or ODC (n = 32). Outcome measures were nutritional status (PG-SGA), weight loss, handgrip strength (HGS), body composition, and survival. Results: Weight loss and impaired nutritional parameters during oncological treatment were seen equally in both groups (NS). Leaner patients at baseline maintained their weight, while overweight patients lost both weight and handgrip strength during treatment. Disease-free survival (DFS) (median = 43 months) was not affected by weight loss during treatment. Lower baseline HGS and malnutrition were associated with worse DFS (low vs. normal HGS: 15 vs. 42 months; p = 0.05 and malnutrition vs. good nutrition status: 17 vs. 42 months; p = 0.014, respectively). Survival according to low vs. normal HGS in the INC group was 4 vs. 44 months (p = 0.007) and in the ODC group 28 vs. 40 months (p = 0.944). According to malnutrition vs. good nutritional status in the INC group, DFS was 21 vs. 43 months (p = 0.025) and in the ODC group 15 vs. 41 months (p = 0.03). Conclusions: As for our primary endpoint, individualized on-demand nutritional counseling was as efficacious as intensive counseling in preventing deterioration of nutritional status and incidence of malnutrition during (chemo) radiotherapy. This should be verified with larger number of patients. Additional findings were that overweight patients had more severe weight loss, but not poorer survival. Low HGS and malnutrition at baseline were associated with poor survival. Clinical Trial Registration: www.ClinicalTrials.gov, identifier NCT02159508.

Dataset Information

A Bioadhesive Barrier-Forming Oral Liquid Gel Improved Oral Mucositis and Nutritional Status in Patients With Head and Neck Cancers Undergoing Radiotherapy: A Retrospective Single Center Study.

Background

Methods

Results

Conclusion

Publications

A Bioadhesive Barrier-Forming Oral Liquid Gel Improved Oral Mucositis and Nutritional Status in Patients With Head and Neck Cancers Undergoing Radiotherapy: A Retrospective Single Center Study.

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