Author(s): ,
Anca Colita
Pediatric Hematology & BMT,FUNDENI CLINICAL INSTITUE,Bucharest,Romania;Pediatric Clinic,'Carol Davila' University of Medicine and Pharmacy,Bucharest,Romania
Andra Bediman
Pediatric Hematology & BMT,FUNDENI CLINICAL INSTITUE,Bucharest,Romania
Andrei Colita
Hematology @ BMT Department,Coltea Hospital,Bucharest,Romania
Constantin Arion
Hematology @ BMT Department,FUNDENI CLINICAL INSTITUE,Bucharest,Romania
EHA Library. Colita A. Jun 12, 2015; 100076; E1179 Disclosure(s): FUNDENI CLINICAL INSTITUE
Pediatric Hematology & BMT
Assoc. Prof. Anca Colita
Assoc. Prof. Anca Colita
Abstract: E1179

Type: Eposter Presentation

Polyvynilpyrrolidone-zn gluconate and taurine (GelX) is an oral lubricating gel used in the management of oral mucositis (OM). OM is an important medical and nursing problem secondary to use of chemotherapy, associated with oral pain and reduced oral intake,  difficult to manage, especially in young children, with important impact for quality of life and nutritional status. GelX forms an adherent barrier and cover the oral mucosa lesions, thus protecting the sensitive nerves endings and lubricating the oral tissue.

To evaluate the efficacy of Gel X as prophylactic or curative treatment for children treated with chemotherapy for hematologic malignant diseases.

We conducted a single-centre prospective and observational study in children with acute leukemias receiving chemotherapy according to the BFM protocols. The parents signed the informed consent. The study was non-sponsored. In the prophylactic arm, the oral cavity nursing with GelX started on the first day of chemotherapy and continued until the recovery from neutropenic phase; for the curative arm, the oral cavity nursing started on the first day of chemotherapy with other oral rinses and was switched to GelX after OM development and continued until OM recovery. The oral rinses were recommended to be used at least 3 times a day according to the product specifications. The OM was assessed daily by the physicians using the WHO grading 0-4 (0=absent, 1= soreness and/or erythema, 2= erythema, ulcers and patient can swallow solid food, 3= ulcers with extensive erythema and patient cannot swallow solid food, 4=mucositis to the extent that alimentation is not possible). We performed also a patient assessment for pain (general, mouth and throat) VAS scale 1-5 (1=no pain, 2=mild pain, 3=moderate pain, 4=severe pain, 5=very severe pain)  and saliva  VAS scale 1-5 for a) swallowing ( 1=normal, 2=cannot swallow certain solid foods, 3=can only swallow soft foods,4=can only swallow liquid foods,5=cannot swallow), b) saliva amount (1=normal amount, 2=mid loss of saliva, 3=moderate loss of saliva, 4=severe loss of saliva, 4=severe loss of saliva, 5= no saliva) and c) consistency of saliva (1=normal, 2=slightly thick, 3=moderately thick, 4=extremely thick, 5=saliva that dries in mouth or lips). The tolerability of oral rinses was evaluated daily by the patients or parents using the Visual Analog Scale (VAS) scoring 1-5: 1= tolerable without any problems, 2=satisfactory, 3= indifferent, 4= unsatisfactory, 5=intolerable. The OM pain reduction and food intake improvement were assessed by the patients/parents using the VAS scoring 1-5 (1=excellent, 2=good, 3=slight effect, 4=almost no effect, 5=no effect at all). Basic statistics univariate analysis were performed using statistical software with the Fisher’s exact test. The “P” values <0.05 were considered as statistically significant differences.

A total of 15 patients were enrolled in this analysis, 8 in the prophylactic arm (group A) and 7 in the curative arm (group B). Characteristics of the groups were shown in Table 1. The OM maximum grade was higher in the B group than in the A group, p=0,018. The patient/parent assessment of mouth pain (p=0,01) and of saliva consistency (p=0,033)  were significantly lower in the prophylactic group. We also observed a significant difference regarding the OM pain reduction (p=0,001), oral intake improvement (p=0,001) and use of systemic analgesics (p=0,005). There were no difference in the median value of tolerability of GelX rinses between the group A and B.

There are limited data regarding the use in children as prophylactic or curative measures. In our study, the oral spray was administered as prophylaxis or as curative treatment. Our results showed better results in the OM development and quality of life in the prophylaxis arm. These results, however, should be considered as informative and larger cohorts of patients needs to be analyzed.


Keyword(s): Chemotherapy toxicity, Children, Mucositis

Session topic: E-poster

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