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

NCT03203733 | Completed

• 1 other identifier: BraincoolUppsalaU
• Study Type: interventional
• Target: 182
• Locations: 2 countries
• Sites: 5

Brief 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

Keywords

Oral Mucositis , cooling, cryotherapy

Outcome Measures

Primary Outcomes (1)

• OM according to OMAS total during 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

Study Arms (2)

'Cooral™'

EXPERIMENTAL

oral cooling with use of cooling device

Device: Cooral™

cryotherapy

ACTIVE COMPARATOR

Cryoterapy consists of ice cubes or crossed ice and used as standard treatment for oral cooling.

Other: cryotherapy

Interventions

Cooral™ DEVICE

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.

'Cooral™'

cryotherapy OTHER

Oral cooling by ice chips or crushed ice or ice pop

cryotherapy

Eligibility Criteria

• Age: 16 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

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

Sponsors & Collaborators

• Uppsala University: lead

Study Sites (5)

Rikshospitalet in Oslo

Oslo, Norway

Location

Linköping University Hospital

Linköping, Sweden

Location

Örebro University Hospital

Örebro, Sweden

Location

Karolinska University Hospital

Stockholm, Sweden

Location

Uppsala University Hospital

Uppsala, Sweden

Location

Related Publications (9)

• Peterson DE, Bensadoun RJ, Roila F; ESMO Guidelines Working Group. Management of oral and gastrointestinal mucositis: ESMO Clinical Practice Guidelines. Ann Oncol. 2011 Sep;22 Suppl 6(Suppl 6):vi78-84. doi: 10.1093/annonc/mdr391. No abstract available.

  PMID: 21908510 BACKGROUND

• Lalla RV, Bowen J, Barasch A, Elting L, Epstein J, Keefe DM, McGuire DB, Migliorati C, Nicolatou-Galitis O, Peterson DE, Raber-Durlacher JE, Sonis ST, Elad S; Mucositis Guidelines Leadership Group of the Multinational Association of Supportive Care in Cancer and International Society of Oral Oncology (MASCC/ISOO). MASCC/ISOO clinical practice guidelines for the management of mucositis secondary to cancer therapy. Cancer. 2014 May 15;120(10):1453-61. doi: 10.1002/cncr.28592. Epub 2014 Feb 25.

  PMID: 24615748 BACKGROUND

• Elting LS, Keefe DM, Sonis ST, Garden AS, Spijkervet FK, Barasch A, Tishler RB, Canty TP, Kudrimoti MK, Vera-Llonch M; Burden of Illness Head and Neck Writing Committee. Patient-reported measurements of oral mucositis in head and neck cancer patients treated with radiotherapy with or without chemotherapy: demonstration of increased frequency, severity, resistance to palliation, and impact on quality of life. Cancer. 2008 Nov 15;113(10):2704-13. doi: 10.1002/cncr.23898.

  PMID: 18973181 BACKGROUND

• Naidu MU, Ramana GV, Rani PU, Mohan IK, Suman A, Roy P. Chemotherapy-induced and/or radiation therapy-induced oral mucositis--complicating the treatment of cancer. Neoplasia. 2004 Sep-Oct;6(5):423-31. doi: 10.1593/neo.04169.

  PMID: 15548350 BACKGROUND

• Legert KG, Remberger M, Ringden O, Heimdahl A, Dahllof G. Reduced intensity conditioning and oral care measures prevent oral mucositis and reduces days of hospitalization in allogeneic stem cell transplantation recipients. Support Care Cancer. 2014 Aug;22(8):2133-40. doi: 10.1007/s00520-014-2190-7. Epub 2014 Mar 20.

  PMID: 24647488 BACKGROUND

• Rubenstein EB, Peterson DE, Schubert M, Keefe D, McGuire D, Epstein J, Elting LS, Fox PC, Cooksley C, Sonis ST; Mucositis Study Section of the Multinational Association for Supportive Care in Cancer; International Society for Oral Oncology. Clinical practice guidelines for the prevention and treatment of cancer therapy-induced oral and gastrointestinal mucositis. Cancer. 2004 May 1;100(9 Suppl):2026-46. doi: 10.1002/cncr.20163.

  PMID: 15108223 BACKGROUND

• Ibrahim A, Mahmoud D, Mavandadipur H, Walladbegi J. Interrater reliability in the assessment of oral mucositis among patients receiving high-dose chemotherapy: a multicenter comparison between specialized dentists and registered nurses. BMC Cancer. 2025 Dec 17;25(1):1874. doi: 10.1186/s12885-025-14670-3.

  PMID: 41408611 DERIVED

• Walladbegi J, Henriksson R, Tavelin B, Svanberg A, Larfors G, Jadersten M, Schjesvold F, Mahdi A, Garming Legert K, Peterson DE, Jontell M. Efficacy of a novel device for cryoprevention of oral mucositis: a randomized, blinded, multicenter, parallel group, phase 3 trial. Bone Marrow Transplant. 2022 Feb;57(2):191-197. doi: 10.1038/s41409-021-01512-6. Epub 2021 Nov 3.

  PMID: 34728786 DERIVED

• Walladbegi J, Svanberg A, Gellerstedt M. Protocol for a randomised controlled trial to study cryoprevention of chemotherapy-induced oral mucositis after autologous stem cell transplantation. BMJ Open. 2018 Oct 24;8(10):e021993. doi: 10.1136/bmjopen-2018-021993.

  PMID: 30361399 DERIVED

MeSH Terms

Conditions

Stomatitis

Interventions

Cryotherapy

Condition Hierarchy (Ancestors)

Mouth Diseases; Stomatognathic Diseases

Intervention Hierarchy (Ancestors)

Therapeutics

Study Officials

• Karin Garming Legert, Dentist, PhD

  Section for Orofacial diagnosis and surgery, Karolinska University Hospital

  PRINCIPAL INVESTIGATOR

• Mats Jontell, dentist

  Oral Medicine Clinic, Department of Odontology, University of Gothenburg

  STUDY DIRECTOR

• 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

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 9, 2017
• First Posted: June 29, 2017
• Study Start: June 12, 2017
• Primary Completion: December 6, 2019
• Study Completion: December 31, 2019
• Last Updated: November 20, 2020

Record last verified: 2020-11

Data Sharing

• IPD Sharing: Will not share

Locations

SE (4); NO (1)