Randomized controlled and double‐blinded study of Caphosol versus saline oral rinses in pediatric patients with cancer

Abstract

Background Oral mucositis (OM) is a significant side effect of cancer treatment. The purpose of this study was to compare topically administered Caphosol to saline rinses in the prevention of mucositis in pediatric cancer patients. Procedure A controlled, double‐blinded, and randomized clinical crossover study recruited patients between 2 to 17.99 years of age who were diagnosed with a malignancy and were receiving either high‐dose methotrexate (≥1 g/m2), anthracycline, or cisplatin chemotherapy (NCT0280733). All patients received two 7‐day cycles of the mouth rinses; that is, one cycle of Caphosol and one cycle of saline in a randomized order. Oral changes and symptoms were evaluated using the World Health Organisation (WHO) toxicity scale and the Children's International Mucositis Evaluation Scale (ChIMES). The primary endpoint was the frequency and severity of OM and oral symptoms. Results A total of 56 patients were recruited to the study, of whom 45 were randomized with a median age of 6.5 years (range 2.1‐17.1 years). No cases of severe OM were observed. Grade ≥ 3 oral symptoms were present at least once in six (13%) patients during the Caphosol cycle and 13 (29%) patients during the saline cycle (P = .12). The peak of symptom scores was evident at around day 4‐7 after administration of the chemotherapy with no marked differences between the rinse solutions. Multivariable regression analysis did not indicate a benefit of using Caphosol over the saline solution. Conclusions No difference in prevention of oral mucositis was observed between the use of Caphosol or saline rinses.

Effect of a supersaturated calcium-phosphate rinse on oral mucositis in patients undergoing hematopoietic stem cell transplantation (HSCT): a systematic review and meta- analysis

“…All studies used SCPR in two 15 ml ampules to prevent and treat HSCT-induced OM in the intervention groups. However, the control regimes in the studies differed: NaCl 0.9% [18,39,41], palifermin [38], chlorhexidine-chlorobutanol (Eludril®) [44], NaF 0.01% rinse [20], chlorhexidine gluconate + benzydamine hydrochloride (Andorex®) [45], black mulberry syrup [45], topical mouth solutions [21], ltered water [42], calcium-phosphate in two 225 ml bottles (Fomukal®) [43] and an oral hygiene protocol with or without an extra-soft toothbrush [40].…”

“…The severity of OM was reported as the incidence of moderate and severe OM. The used grading scales for OM were World Health Organization (WHO) Oral Toxicity Scale [18,21,38,[40][41][42][43][44][45], National Cancer Institute Common Toxicity Criteria Grading Scale (NCI-CTCAE) [39] and the National Institute of Dental and Craniofacial Research (NIDCR) [20]. Detailed information is shown in Table 1.…”

“…There were 8 RCTs [18, 20, 21, 39-43] and 3 NRSIs [38,44,45]. One RCT was designed as a cross-over study with two cycles of 7 days [41]. Of the 3 NRSIs, 2 were designed as cohort studies [38,44] and 1 as a non-randomized controlled trial [45].…”

“…The studies included a total of 837 participants, with a range of 29-220. Six of the included studies recruited only adult patients [20,21,38,42,43], 1 study included both adults and children [44], and 4 studies included pediatric patients only [18, [39][40][41]. The haematological cancer type for which patients were being treated was leukemia in 8 studies [20,21,38,40,[42][43][44][45], lymphoma in 5 studies [20,38,42,43,45], multiple myeloma in 5 studies [20,38,42,43,45], and solid tumors in 3 studies [18, 39,41].…”

Validation of healthcare professional proxy‐reported children’s International Mucositis Evaluation Scale

“…This implementation could be in the context of routine clinical care or within the design and conduct of clinical trials. (Immonen et al, 2020;Khurana et al, 2013;Ribeiro da Silva et al, 2018;Treister et al, 2017).…”