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

Not Applicable

Completed

• Conditions: Pain; Infection; Nutrition Aspect of Cancer; Oral Mucositis
• Interventions: Other: Cryotherapy

• Registration Number: NCT01789658
• Lead Sponsor: Uppsala University

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

Study Timeline

• Study Start: 2012-10
• Study First Submitted: 2013-02-05
• Study First Submitted QC: 2013-02-08
• Study First Posted: 2013-02-12
• Primary Completion: 2016-06
• Status Verified: 2016-10
• Study Completion: 2016-10
• Last Update Submitted: 2016-10-26
• Last Update Posted: 2016-10-27

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 53

Inclusion Criteria

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

Exclusion Criteria

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Cryotherapy	Cryotherapy	Cryotherapy during conditioning treatment with chemotherapy prior to HSCT

Primary Outcome Measures

Name	Time	Method
Mucositis grade - WHO Oral Toxicity Scale	Daily until engraftment, an expected average of 20 days.	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.

Secondary Outcome Measures

Name	Time	Method
Mucositis grade - Children´s International Mucositis Evaluation Scale (ChiMES)	Daily until engraftment, an expected average of 20 days.	Daily evaluation by child and parent.
Pain - Childrens Hospital Eastern Ontario Pain Scale (CHEOPS)	Daily until Engraftment an expected average of 20 days.	Daily assessment by nurse
Mouth Pain	Daily until Engraftment an expected average of 20 days	Mouth Pain measured with Numerical Rating scale(NRS)for children \>7 years and parents and Facial Pain Scale(FPS) for children \< 7 years
Emotional and Psychological status	Daily until engraftment, an expected average of 20 days.	Beck youth inventories for depression and anxiety

Trial Locations

Locations (5)

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