Oral cryotherapy for oral mucositis management in patients receiving allogeneic hematopoietic stem cell transplantation: a prospective randomized study

Support Care Cancer. 2020 Apr;28(4):1747-1754. doi: 10.1007/s00520-019-04966-z. Epub 2019 Jul 13.

Abstract

Purpose: To explore the best schedule of oral cryotherapy for the prevention of oral mucositis in recipients of myeloablative hematopoietic stem cell transplantation (HSCT).

Methods: A prospective randomized study was conducted to recruit allogeneic HSCT recipients, who were then randomly allocated into four arms to accept the following: oral cryotherapy during the whole course (arm A) or second half of the course (arm B) of cytotoxic agents administration, regular oral cryotherapy twice a day (arm C), or conventional oral care without cryotherapy (arm D). Status of oral mucositis was daily assessed from the first day of conditioning to the 15th day post-HSCT. A myeloablative conditioning regimen was used which was composed of busulfan, cyclophosphamide, and cytarabine.

Results: Totally 160 cases were consecutively enrolled in this study, and 145 cases were eligible for oral mucositis assessment. Both arm A and arm B were associated with a lower incidence and short duration of severe mucositis (≥ grade 3), although no statistical difference was found between these two groups (p = 0.463, p = 0.678). The highest incidence of severe mucositis was observed in arm C. Recovery of mucositis also had a significant diversity among the 4 arms (F = 4.133, p = 0.008).

Conclusions: Risk and outcome of severe oral mucositis could be ameliorated by oral cryotherapy during the administration of cytotoxic agents for allogeneic HSCT patients receiving non-radiation myeloablative conditioning regimen, and a half-course schedule could acquire a comparable efficacy compared with the whole-course schedule.

Keywords: Allogeneic hematopoietic stem cell transplantation; Cryotherapy; Oral mucositis.

Publication types

  • Randomized Controlled Trial

MeSH terms

  • Adult
  • Busulfan / administration & dosage
  • Busulfan / adverse effects
  • Cryotherapy / methods*
  • Cyclophosphamide / administration & dosage
  • Cyclophosphamide / adverse effects
  • Cytarabine / administration & dosage
  • Cytarabine / adverse effects
  • Female
  • Hematopoietic Stem Cell Transplantation / methods*
  • Humans
  • Incidence
  • Male
  • Middle Aged
  • Myeloablative Agonists / administration & dosage
  • Myeloablative Agonists / adverse effects*
  • Prospective Studies
  • Stomatitis / chemically induced
  • Stomatitis / prevention & control*
  • Stomatitis / therapy*
  • Transplantation Conditioning / adverse effects*
  • Young Adult

Substances

  • Myeloablative Agonists
  • Cytarabine
  • Cyclophosphamide
  • Busulfan