At a glance
ClinicalIndex Comparison RecordStandardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
Cryoprotection of Chemotherapy-induced Oral Mucositis After Autologous Stem Cell Transplantation, a Randomized Study
In Brief
A clinical study evaluating Cooral™ and cryotherapy for Cryotherapy Effect. Completed, enrolled 182 participants across 5 sites in 2 countries.
Detailed Summary
This study evaluates, among study patients with lymphoma or myeloma undergoing autologous SCT, whether cooling oral mucosa with a cooling device compared with ice cubes/crushed ice or ice pop succeeds in reducing the degree of oral mucositis (OM) according to the Oral Mucositis Assessment Scale (OMAS) total,degree of OM according to World Health Organisation (WHO), tolerability of either cooling method. The study is also aiming to , patients subjective experience of OM, rating of general quality of life and oral pain, number of days with total parenteral nutrition (TPN), number of hospital days, total dose of opioids, and C reactive protein during time in care. Finally, the study aims to evaluate weight loss, Leukocyte particle concentration, number of days until bone marrow response, S-albumin, and body temperature.
Study Details
Timeline
Interventions
An intraoral cooling device which is as effective as ice but with better patient comfort. The cooling device has the advantage that the water temperature can be modified. It enables that the unacceptable low temperatures that occur with ice cooling can be avoided.
Oral cooling by ice chips or crushed ice or ice pop