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

November 19, 2020 updated by: Uppsala University

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 Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

The degree of OM is assessed at eight intraoral locations, in accordance with the Oral Mucositis Assessment Scale (OMAS) (graded 0-3 for ulceration and 0-2 for erythema). 0 corresponds to "normal" while 3 and 2 are "sore >3 cm2" and "severe erythema" respectively. The assessment generates both an average for OMAS ulceration (0-3) and OMAS erythema (0-2) and a total average OMAS (0-5), which is the mean of both ulceration and erythema.

Besides OMAS, ulceration and erythema are also assessed with the WHO scale (graded 0-4) where 0 is "no mucositis" and 4 is "ulceration, total parenteral nutrition".

Assessment with OMAS and WHO is done by a dentist, blinded to treatment group, three times a week, for example, Monday, Wednesday, Friday, until discharge or at most day +28.Assessment with the WHO is also performed by nurses who are not blinded to the treatment group, three times a week.

Furthermore, the patients, after cooling ends, assess the tolerability of the respective cooling method with the aid of a questionnaire developed for the study. The questionnaire is intended to give some idea of any discomfort or side effects the patients feel as a result of the cooling method.

The patients assess their perception of oral problems daily with the aid of specific questions in a diary developed for the study. The questions are intended to give a picture of the effect of OM on the patient's general status.

General quality of life is assessed twice during the study period, before the start of treatment and at discharge, with a validated quality of life instrument.

Oral pain is assessed with a visual analog scale (VAS) with the extremes graded on a 10-figure scale (0-10) where 0 is "no pain" and 10 is "unbearable pain".

Information about total parenteral nutrition (TPN), number of hospital days, total dose of opioids, weight loss, and body temperature will be retrieved from patient records. Laboratory results of blood tests will be retrieved from each department's register of test results.

The result of the assessments is documented on sheets for the purpose in a patient's individual kardex.

Study Type

Interventional

Enrollment (Actual)

182

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Norway
      • Oslo, Norway
        • Rikshospitalet in Oslo
  • Sweden
      • Linköping, Sweden
        • Linköping University Hospital
      • Stockholm, Sweden
        • Karolinska University Hospital
      • Uppsala, Sweden
        • Uppsala University Hospital
      • Örebro, Sweden
        • Orebro University Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

14 years and older (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Patients between 16 and 99 years of age diagnosed with lymphoma or myeloma
  • Able to communicate in Swedish
  • Treated with bis-chloroethylnitrosourea, etoposide, cytarabine, and cyclophosphamide(BEAC) or bis-chloroethylnitrosourea, etoposide, cytarabine, and melphalan (BEAM) (lymphoma diagnosis), melphalan (myeloma diagnosis), before stem cell transplantation (SCT)

Exclusion Criteria:

  • Patients who do not understand oral and written information in Swedish.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 'Cooral™'
oral cooling with use of cooling device
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.
Active Comparator: cryotherapy
Cryoterapy consists of ice cubes or crossed ice and used as standard treatment for oral cooling.
Other: cryotherapy
Oral cooling by ice chips or crushed ice or ice pop

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
OM according to OMAS total during 28 days or until discharge
Time Frame: 28 days or until discharge
Assesment with OMAS is done by a dentist blinded to treatment group, three times a week during 28 days or until discharge. Assessment with the not blinded to the treatment group, three times a week during 28 days or until discharge.
28 days or until discharge

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Uppsala University

Investigators

  • Principal Investigator: Karin Garming Legert, Dentist, PhD, Section for Orofacial diagnosis and surgery, Karolinska University Hospital
  • Study Director: Mats Jontell, dentist, Oral Medicine Clinic, Department of Odontology, University of Gothenburg
  • Principal Investigator: Torbjörn Karlsson, MD physician, Section for Hematology & Coagulation, Uppsala University Hospital
  • Principal Investigator: PA Broliden, MD, PhD,, Hematology Center, M54, Karolinska University Hospital
  • Principal Investigator: Franz Rommel, physician, Section for Hematology, Linköping University Hospital
  • Principal Investigator: Erik Ahlstrand, physician, Section for Hematology, Örebro University Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 12, 2017

Primary Completion (Actual)

December 6, 2019

Study Completion (Actual)

December 31, 2019

Study Registration Dates

First Submitted

June 9, 2017

First Submitted That Met QC Criteria

June 26, 2017

First Posted (Actual)

June 29, 2017

Study Record Updates

Last Update Posted (Actual)

November 20, 2020

Last Update Submitted That Met QC Criteria

November 19, 2020

Last Verified

November 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • BraincoolUppsalaU

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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