Cryotherapy for Prevention of Oral Mucositis in Children Undergoing Hematopoietic Stem Cell Transplantation

NCT ID: NCT01789658

Last Updated: 2016-10-27

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 53 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2012-10-31
• Study Completion Date: 2016-10-31

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.

Detailed Description

There is a complex pathobiology behind OM; chemo and radiotherapy affects the mucosa and submucosa causing DNA-strand brakes and generation of reactive oxygen species (ROS). This initiates a cascade of events, among others activation of transcription factors, up-regulation of pro-inflammatory cytokines, and activation of macrophages and proteases leading to tissue injury causing symptoms such as erythema, edema, ulceration, taste perception alterations, and mouth dryness. OM often causes local and systemic infections, fatigue, pain, and difficulties in basal functions such as swallowing (and hence drinking and eating) and talking and reduces patients' psychological well-being. Nearly 90 % of pediatric patients undergoing HSCT are afflicted with OM. In pediatric patients mucositis is reported as one of the most painful and debilitating side effects during cancer treatment.Beyond a significant suffering for the patient it is hence associated with higher costs for health care and increased mortality.

The current scientific situation regarding prevention and treatment of OM has been summarized in Cochrane reports showing limited data on adults and practically missing data on children and adolescents. Concluding guidelines from these reports emphasize the need for well conducted randomized controlled trials (RCT's) to evaluate and refine treatments in order to establish evidence based interventions.

The use of cryotherapy to prevent oral mucositis in patients who are receiving high-dose chemotherapy as a conditioning agent prior to HSCT continue to show evidence in the adult population.

The aim of this study is to compare treatment with cryotherapy (Arm 1)with a standard oral care protocal (Arm 2)

ARM 1 Children are instructed to use chew on ice-chips, ingest ice-cream or ice-water during infusion of chemotherapy as part of the conditioning treatment prior to HSCT. Melted ice should be replaced by new as soon as possible. Children receiving a 24-hour infusion are instructed to use cryotherapy for one hour 4 times a day.

ARM 2 Standard care for prevention and management of oral mucositis

Primary outcome

• Degree and duration of Oral mucositis

Secondary outcomes

• Oral pain
• Opioid use
• Duration of parenteral nutrition
• Weight loss
• Duration of neutropenic fever
• Duration of antibiotic treatment
• Duration of hospitalization
• Emotional and psychological status
• C reactive protein (CRP) and s-albumin correlation to grade of Oral Mucositis

Conditions

Oral Mucositis; Pain; Infection; Nutrition Aspect of Cancer

Keywords

Oral Mucositis; Children; Cryotherapy; Hematopoietic Stem Cell Transplantation

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: SINGLE

Study Groups

Cryotherapy

Cryotherapy during conditioning treatment with chemotherapy prior to HSCT

Group Type: EXPERIMENTAL

Cryotherapy

Intervention Type: OTHER

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

Control

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

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Cryotherapy

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

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

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

Exclusion Criteria

-

• Minimum Eligible Age: 4 Years
• Maximum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

The Swedish Childhood Cancer Foundation

UNKNOWN

Sponsor Role: collaborator

Uppsala University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Gustaf Ljungman, MD, PhD

Role: STUDY_DIRECTOR

Uppsala University

Locations

Pediatric Oncology Department, Queen Silvia Childrens´ Hospital

Gothenburg, , Sweden

Departent of Pediatric Oncology, Lund University Hospital

Lund, , Sweden

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

Stockholm, , Sweden

Department of pediatrics B78, Karolinska University Hospital

Stockholm, , Sweden

Department of Hematology, Uppsala University Hospital

Uppsala, , Sweden

Countries

Sweden

References

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.

Reference Type: DERIVED

PMID: 31993753 (View on PubMed)

Other Identifiers

UU-OM-01

Identifier Type: -

Identifier Source: org_study_id