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Cryoprotection of Chemotherapy-induced Oral Mucositis After Autologous Stem Cell Transplantation, a Randomized Study

NCT03203733 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 182

Last updated 2020-11-20

No results posted yet for this study

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.

Conditions

  • Cryotherapy Effect

Interventions

DEVICE

Cooral™

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.

OTHER

cryotherapy

Oral cooling by ice chips or crushed ice or ice pop

Sponsors & Collaborators

  • Uppsala University

    lead OTHER

Principal Investigators

  • Karin Garming Legert, Dentist, PhD · Section for Orofacial diagnosis and surgery, Karolinska University Hospital

  • Mats Jontell, dentist · Oral Medicine Clinic, Department of Odontology, University of Gothenburg

  • Torbjörn Karlsson, MD physician · Section for Hematology & Coagulation, Uppsala University Hospital

  • PA Broliden, MD, PhD, · Hematology Center, M54, Karolinska University Hospital

  • Franz Rommel, physician · Section for Hematology, Linköping University Hospital

  • Erik Ahlstrand, physician · Section for Hematology, Örebro University Hospital

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
16 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-06-12
Primary Completion
2019-12-06
Completion
2019-12-31

Countries

  • Norway
  • Sweden

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03203733 on ClinicalTrials.gov