Caphosol for prevention of oral mucositis in pediatric myeloablative haematopoietic cell transplantation

Abstract

Background:The primary objective was to determine whether topically administered Caphosol, rinsed orally four times daily at the initiation of conditioning, reduces the duration of severe oral mucositis (OM) compared with placebo among children and adolescents undergoing haematopoietic cell transplantation (HCT).Methods:This was a Children's Oncology Group multicentre randomised double-blinded placebo-controlled clinical trial. Patients between the ages of 4 and 21 years who were scheduled to undergo myeloablative HCT for any indication were randomised to Caphosol or placebo saline rinses four times daily from initiation of conditioning through day +20. Subjects were assessed daily for OM using the World Health Organisation (WHO) Oral Toxicity Scale, Mouth Pain Categorical Scale (0–10) and the Oral Mucositis Daily Questionnaire (OMDQ). The primary end point was duration of severe OM (WHO ⩾3).Results:The study enrolled 220 participants with a median age of 13.7 years (range 4.0–21.9); 163 (74%) received allogeneic HCT. The mean (±s.d.) duration of severe OM was not reduced among Caphosol (4.5±5.0 days) vs placebo (4.5±4.8; P=0.99) recipients. The incidence of severe OM in the Caphosol and placebo arms was 63% (57 out of 91) and 68% (62 out of 91), respectively (P=0.44). There were no significant differences in any of the secondary end points between the groups.Conclusions:Caphosol did not reduce severe OM when compared with placebo among children and adolescents undergoing myeloablative HCT. Studies to identify effective interventions for OM are needed in this population.

Management of oral mucositis in pediatric patients receiving cancer therapy: A systematic review and meta‐analysis

“…Development of OM can also increase mortality by nearly 40% in severe cases . Severe cases are associated with ulcerated mucosa and secondary infection, which may result in life‐threatening sepsis . Oral and gastrointestinal mucosa inflammation can cause severe ulcers, infections, and problems or shortcomings in basic tasks like swallowing or consuming foods or drinks.…”

“…6 Severe cases are associated with ulcerated mucosa and secondary infection, which may result in life-threatening sepsis. 7,8 Oral and gastrointestinal mucosa inflammation can cause severe ulcers, infections, and problems or shortcomings in basic tasks like swallowing or consuming foods or drinks. OM also has a major impact on quality of life and nutritional status, prolonged hospital stays, and [9][10][11] For all these reasons, it is crucial that OM be prevented or treated as quickly as possible.…”

Oral administration of nanomicelle curcumin in the prevention of radiotherapy‐induced mucositis in head and neck cancers

“…13 Despite being efficacious, palifermin, as a recombinant growth factor, is expensive, not simple to use, and thus unaffordable for most patients. [14][15][16][17] Curcumin [1,7-bis (4-hydroxy-3-methoxyphenyl)-1,6heptadiene-3,5-dione] is a polyphenolic compound and the major yellow pigment extracted from the rhizome of turmeric (Curcuma longa), which belongs to the ginger family, Zingeberaceae. 18 Curcumin has been shown to possesses diverse pharmacologic activities including antioxidant, anti-inflammatory, antimicrobial, and anticarcinogenic effects.…”

Systematic review of natural and miscellaneous agents for the management of oral mucositis in cancer patients and clinical practice guidelines—part 1: vitamins, minerals, and nutritional supplements

“…A search for recently published articles about SCPR identified a large RCT, which concluded that SCPR was ineffective in the management of OM in H&N cancer patients treated with RT/RT-CT [83]. A recent RCT in pediatric patients [84] and comparative studies about SCPR indicated conflicting results about the effectiveness in preventing OM [23,85].…”