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

Pain Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01789658
• Other study ID #: UU-OM-01
• Status: Completed
• Phase: N/A
• First received: February 5, 2013
• Last updated: October 26, 2016
• Start date: October 2012
• Est. completion date: October 2016

Study information

• Verified date: October 2016
• Source: Uppsala University
• Contact: n/a
• Is FDA regulated: No
• Health authority: Sweden: Regional Ethical Review Board
• Study type: Interventional

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 53
• Est. completion date: October 2016
• Est. primary completion date: June 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 4 Years to 18 Years

Eligibility

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

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

Related Conditions & MeSH terms

• Infection
• Mucositis
• Nutrition Aspect of Cancer
• Oral Mucositis
• Pain
• Stomatitis

Intervention

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

Locations

Country	Name	City	State
Sweden	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

Sponsors (2)

Lead Sponsor	Collaborator
Uppsala University	The Swedish Childhood Cancer Foundation

Country where clinical trial is conducted

Sweden, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Opioid consumption	Days with, and dose of morphine-equivalent opioids	During hospitalization in connection with HSCT, an expected average of 25 days	Yes
Other	Duration of parenteral nutrition	Days with Total Parenteral Nutrition	During hospitalization in connection with HSCT, an expected average of 25 days	Yes
Other	Weight Loss	Weight Loss in kilograms from admission to date of engraftment	During hospitalization in connection with HSCT, an expected average of 25 days	Yes
Other	Duration of Antibiotic treatment	Days with antibiotics	During hospitalization in connection with HSCT, an expected average of 25 days	Yes
Other	Duration of febrile neutropenia	Days with fever >38.0 degrees	Until engraftment, an expected average of 20 days	Yes
Other	Duration of Hospitalisation	Counted from day 0 until discharge either home or to region hospital.	During hospitalization in connection with HSCT, an expected average of 25 days	Yes
Other	C reactive protein	Level of p-CRP in comparison to grade of mucositis	During hospitalization in connection with HSCT, an expected average of 25 days	Yes
Other	S-Albumin	In correlation to grade of Oral Mucositis	During hospitalization in connection with HSCT, an expected average of 25 days	No
Primary	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.	Yes
Secondary	Mucositis grade - Children´s International Mucositis Evaluation Scale (ChiMES)	Daily evaluation by child and parent.	Daily until engraftment, an expected average of 20 days.	Yes
Secondary	Pain - Childrens Hospital Eastern Ontario Pain Scale (CHEOPS)	Daily assessment by nurse	Daily until Engraftment an expected average of 20 days.	Yes
Secondary	Mouth Pain	Mouth Pain measured with Numerical Rating scale(NRS)for children >7 years and parents and Facial Pain Scale(FPS) for children < 7 years	Daily until Engraftment an expected average of 20 days	Yes
Secondary	Emotional and Psychological status	Beck youth inventories for depression and anxiety	Daily until engraftment, an expected average of 20 days.	Yes