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A Randomized Controlled Trial of Cryotherapy for Prevention and Reduction of Severity of Oral Mucositis in Children Undergoing Hematopoietic Stem Cell Transplantation.

4 Years
18 Years
Open (Enrolling)
Oral Mucositis, Pain, Infection, Nutrition Aspect of Cancer

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Trial Information

A Randomized Controlled Trial of Cryotherapy for Prevention and Reduction of Severity of Oral Mucositis in Children Undergoing Hematopoietic Stem Cell Transplantation.

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

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

Inclusion Criteria:

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

Exclusion Criteria:


Type of Study:


Study Design:

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Investigator), Primary Purpose: Prevention

Outcome Measure:

Mucositis grade - WHO Oral Toxicity Scale

Outcome Description:

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.

Outcome Time Frame:

Daily until engraftment, an expected average of 20 days.

Safety Issue:


Principal Investigator

Gustaf Ljungman, MD, PhD

Investigator Role:

Study Director

Investigator Affiliation:

Uppsala University


Sweden: Regional Ethical Review Board

Study ID:




Start Date:

October 2012

Completion Date:

July 2014

Related Keywords:

  • Oral Mucositis
  • Pain
  • Infection
  • Nutrition Aspect of Cancer
  • Oral Mucositis
  • Children
  • Cryotherapy
  • Hematopoietic Stem Cell Transplantation
  • Stomatitis
  • Mucositis