Oral mucositis (OM) is a debilitating adverse effect of the conditioning regimen for hematopoietic stem cell transplantation (HSCT) experienced by many patients with hematologic cancer who undergo the procedure. Therefore, a team of researchers conducted a nonrandomized phase 2 study to determine if adding products containing bovine colostrum and Aloe vera to standard care might counteract the mucosal soreness, ulcers, and other effects of the condition, and promote healing. Their findings were published in the Annals of Hematology.
The researchers sought to assess the safety and efficacy of the combination regimen, recruiting 59 patients from a hematology unit. Participants were given 2 commercially available products containing bovine colostrum and Aloe vera, in addition to following the standard protocol: a mouthwash (Remargin Colostrum OS®) and an oral dietary supplement (Remargin Colostrum Gastro-Gel®). The standard protocol entailed gentle cleansing with toothpaste and a saline rinse after meals (or 3 times daily), with increased frequency after oral mucositis developed.
The primary endpoint was incidence of severe OM (grade 3-4 WHO). Every patient was assessed daily for OM by the nursing staff from the first day of the conditioning regimen through day 21 posttransplantation. Overall OM incidence, time of onset, and duration were evaluated as secondary endpoints. Data on adverse events were collected, and blood cell count, hemoglobin, and creatinine and bilirubin serum levels were monitored.
Continue Reading
Of the 59 patients, 46 (78.0%) developed oral mucositis with 40 (67.8%) mild-moderate cases and 6 (10.2%) severe cases. In a comparison with a homogeneous historical control group, incidence of severe OM was significantly decreased in the patients using the colostrum/Aloe vera products; however, overall OM incidence was similar, as was time of onset and overall duration of OM. Incidence of febrile neutropenia and its mean duration also were reduced in those using the study regimen.
“The oral care protocol investigated in this study showed significant results on [severe OM] incidence without any significant [adverse effects],” the researchers concluded. The activity of the various bioactive substances in bovine colostrum and Aloe vera may explain these results. Secondary findings appear to prove the antimicrobial effects of both compounds the researchers added.
A randomized controlled trial would be useful to provide evidence to support use of the approach in clinical practice.
The study may be limited by reduced patient compliance with oral care protocol due to nausea, vomiting, and taste change leading to patients’ intolerance of the flavor and/or consistency.
Reference
Guberti M, Botu S, Caffarri C, et al. Efficacy and safety of a colostrum- and Aloe vera-based oral care protocol to prevent and treat severe oral mucositis in patients undergoing hematopoietic stem cell transplantation: a single-arm phase II study. Ann Hematol. 2022;101(10):2325-2336. doi:10.1007/s00277-022-04934-4
