NCT01789658

Brief Summary

Oral mucositis (OM) is a common adverse effect of chemotherapy, radiotherapy and conditioning regimens before Hematopoietic Stem Cell Transplantation (HSCT). The aim of this study is to effectiveness of cryotherapy as a prophylactic treatment in children undergoing HSCT.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
53

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Oct 2012

Longer than P75 for not_applicable

Geographic Reach
1 country

5 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2012

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

February 5, 2013

Completed
7 days until next milestone

First Posted

Study publicly available on registry

February 12, 2013

Completed
3.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2016

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2016

Completed
Last Updated

October 27, 2016

Status Verified

October 1, 2016

Enrollment Period

3.7 years

First QC Date

February 5, 2013

Last Update Submit

October 26, 2016

Conditions

Oral MucositisPainInfectionNutrition Aspect of Cancer

Keywords

Oral MucositisChildrenCryotherapyHematopoietic Stem Cell Transplantation

Outcome Measures

Primary Outcomes (1)

  • Mucositis grade - WHO Oral Toxicity Scale

    WHO-Oral toxicity scale Grade 0 - No mucositis Grade 1 - Erythema and/or soreness Grade 2 - Erythema and/or ulcers. Can eat solid food. Grade 3 - Erythema and/or Ulcers. No solid food but can ingest liquids. Grade 4 - Oral alimentation not possible.

    Daily until engraftment, an expected average of 20 days.

Secondary Outcomes (4)

  • Mucositis grade - Children´s International Mucositis Evaluation Scale (ChiMES)

    Daily until engraftment, an expected average of 20 days.

  • Pain - Childrens Hospital Eastern Ontario Pain Scale (CHEOPS)

    Daily until Engraftment an expected average of 20 days.

  • Mouth Pain

    Daily until Engraftment an expected average of 20 days

  • Emotional and Psychological status

    Daily until engraftment, an expected average of 20 days.

Other Outcomes (8)

  • Opioid consumption

    During hospitalization in connection with HSCT, an expected average of 25 days

  • Duration of parenteral nutrition

    During hospitalization in connection with HSCT, an expected average of 25 days

  • Weight Loss

    During hospitalization in connection with HSCT, an expected average of 25 days

  • +5 more other outcomes

Study Arms (2)

Cryotherapy

EXPERIMENTAL

Cryotherapy during conditioning treatment with chemotherapy prior to HSCT

Other: Cryotherapy

Control

NO INTERVENTION

Standard oral Care. No Cryotherapy during conditioning treatment prior to HSCT

Interventions

CryotherapyOTHER

Cryotherapy with ice-chips, ice cream or ice water is given during conditioning treatment with chemotherapy prior to HSCT.

Cryotherapy

Eligibility Criteria

Age4 Years - 18 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • Age between 4-18 Undergoing Hematopoietic Stem Cell Transplantation in Sweden sufficient knowledge in swedish to understand the protocols -

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (5)

Pediatric Oncology Department, Queen Silvia Childrens´ Hospital

Gothenburg, SE-41685, Sweden

Location

Departent of Pediatric Oncology, Lund University Hospital

Lund, SE-22185, Sweden

Location

Center for Allogeneic Stem Cell Transplantation, Karolinska University Hospital, Hudding

Stockholm, SE-14186, Sweden

Location

Department of pediatrics B78, Karolinska University Hospital

Stockholm, Se-14186, Sweden

Location

Department of Hematology, Uppsala University Hospital

Uppsala, SE-75185, Sweden

Location

Related Publications (1)

  • Kamsvag T, Svanberg A, Legert KG, Arvidson J, von Essen L, Mellgren K, Toporski J, Winiarski J, Ljungman G. Prevention of oral mucositis with cryotherapy in children undergoing hematopoietic stem cell transplantations-a feasibility study and randomized controlled trial. Support Care Cancer. 2020 Oct;28(10):4869-4879. doi: 10.1007/s00520-019-05258-2. Epub 2020 Jan 28.

    PMID: 31993753DERIVED

MeSH Terms

Conditions

StomatitisPainInfections

Interventions

Cryotherapy

Condition Hierarchy (Ancestors)

Mouth DiseasesStomatognathic DiseasesNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Therapeutics

Study Officials

  • Gustaf Ljungman, MD, PhD

    Uppsala University

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
INVESTIGATOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 5, 2013

First Posted

February 12, 2013

Study Start

October 1, 2012

Primary Completion

June 1, 2016

Study Completion

October 1, 2016

Last Updated

October 27, 2016

Record last verified: 2016-10

Locations

SE(5)