A Randomized Study to Compare the Effect of Short- and Long-Term Schedules of Cryotherapy on the Incidence and Severity of Mucositis in High-Dose Melphalan
I. To measure the maximum inpatient mucositis grade after 120- vs. 360-minutes standardized
cryotherapy regimens in patients with multiple myeloma undergoing autologous hematopoietic
stem cell transplantation at Ohio State Medical Center.
I. To develop a pharmacokinetic model predicting variability in unbound serum melphalan area
under the concentration-time curve (AUC).
II. To compare the neutropenic fever and bacteremia incidence after 120- vs. 360-minute
III. To compare patient-reported mucositis-related symptoms up until discharge utilizing the
Patient-Reported Oral Mucositis Symptoms Scale (PROMS) after 120- vs 360-minute cryotherapy
OUTLINE: Patients are randomized to 1 of 2 treatment arms.
ARM I: Beginning fifteen minutes before melphalan treatment, patients receive 1 ounce of
shaved ice in their mouth, allow it to melt and then replenish it immediately for 120
ARM II: Beginning fifteen minutes before melphalan treatment, patients receive 1 ounce of
shaved ice in their mouth, allow it to melt and then replenish it immediately for 360
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Incidence of severe (Grade 3 or 4) mucositis achieved between two different cryotherapy regimens during inpatient hospitalization based on the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4
A Cochran-Mantel-Haenszel chi-square test will be used to compare the proportion of patients who develop severe mucositis between those treated with 120-minute vs. 360-minute cryotherapy. Logistic regression modeling will also be used with incidence of severe mucositis as the dependent variable and assess various factors in addition to treatment arm on this incidence.
Craig Hofmeister, MD
Ohio State University
United States: Institutional Review Board
|Ohio State University Medical Center||Columbus, Ohio 43210|