Infection, Nutrition Aspect of Cancer, Oral Mucositis, Pain
Conditions
Keywords
Oral Mucositis, Children, Cryotherapy, Hematopoietic Stem Cell Transplantation
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
Interventions
OTHERCryotherapy
Cryotherapy with ice-chips, ice cream or ice water is given during conditioning treatment with chemotherapy prior to HSCT.
Sponsors
The Swedish Childhood Cancer Foundation
Uppsala University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
SINGLE (Investigator)
Eligibility
Sex/Gender
ALL
Age
4 Years to 18 Years
Healthy volunteers
No
Inclusion criteria
Age between 4-18 Undergoing Hematopoietic Stem Cell Transplantation in Sweden sufficient knowledge in swedish to understand the protocols -
Exclusion criteria
\-
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| Emotional and Psychological status | Daily until engraftment, an expected average of 20 days. | Beck youth inventories for depression and anxiety |
| 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 |
| 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 |
Other
| Measure | Time frame | Description |
|---|---|---|
| Duration of Hospitalisation | During hospitalization in connection with HSCT, an expected average of 25 days | Counted from day 0 until discharge either home or to region hospital. |
| Opioid consumption | During hospitalization in connection with HSCT, an expected average of 25 days | Days with, and dose of morphine-equivalent opioids |
| S-Albumin | During hospitalization in connection with HSCT, an expected average of 25 days | In correlation to grade of Oral Mucositis |
| C reactive protein | During hospitalization in connection with HSCT, an expected average of 25 days | Level of p-CRP in comparison to grade of mucositis |
| Duration of parenteral nutrition | During hospitalization in connection with HSCT, an expected average of 25 days | Days with Total Parenteral Nutrition |
| Weight Loss | During hospitalization in connection with HSCT, an expected average of 25 days | Weight Loss in kilograms from admission to date of engraftment |
| Duration of Antibiotic treatment | During hospitalization in connection with HSCT, an expected average of 25 days | Days with antibiotics |
| Duration of febrile neutropenia | Until engraftment, an expected average of 20 days | Days with fever \>38.0 degrees |
Countries
Sweden
Outcome results
None listed