Cryotherapy for Prevention of Oral Mucositis in Children Undergoing Hematopoietic Stem Cell Transplantation
Condition: Oral Mucositis; Pain; Infection; Nutrition Aspect of Cancer
MeSH terms: Mucositis; Stomatitis
Study type: Interventional

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
    

Intervention name(s): Cryotherapy
Intervention type(s): Other
Intervention description(s): Cryotherapy with ice-chips, ice cream or ice water is given during conditioning treatment with chemotherapy prior to HSCT.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Investigator)
Primary purpose: Prevention
Keywords: Oral Mucositis; Children; Cryotherapy; Hematopoietic Stem Cell Transplantation