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.
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.
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
;
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Investigator), Primary Purpose: Prevention
Status | Clinical Trial | Phase | |
---|---|---|---|
Active, not recruiting |
NCT05559255 -
Changes in Pain, Spasticity, and Quality of Life After Use of Counterstrain Treatment in Individuals With SCI
|
N/A | |
Terminated |
NCT04356352 -
Lidocaine, Esmolol, or Placebo to Relieve IV Propofol Pain
|
Phase 2/Phase 3 | |
Completed |
NCT04748367 -
Leveraging on Immersive Virtual Reality to Reduce Pain and Anxiety in Children During Immunization in Primary Care
|
N/A | |
Completed |
NCT05057988 -
Virtual Empowered Relief for Chronic Pain
|
N/A | |
Completed |
NCT04466111 -
Observational, Post Market Study in Treating Chronic Upper Extremity Limb Pain
|
||
Recruiting |
NCT06206252 -
Can Medical Cannabis Affect Opioid Use?
|
||
Completed |
NCT05868122 -
A Study to Evaluate a Fixed Combination of Acetaminophen/Naproxen Sodium in Acute Postoperative Pain Following Bunionectomy
|
Phase 3 | |
Active, not recruiting |
NCT05006976 -
A Naturalistic Trial of Nudging Clinicians in the Norwegian Sickness Absence Clinic. The NSAC Nudge Study
|
N/A | |
Completed |
NCT03273114 -
Cognitive Functional Therapy (CFT) Compared With Core Training Exercise and Manual Therapy (CORE-MT) in Patients With Chronic Low Back Pain
|
N/A | |
Enrolling by invitation |
NCT06087432 -
Is PNF Application Effective on Temporomandibular Dysfunction
|
N/A | |
Completed |
NCT05508594 -
Efficacy and Pharmacokinetic-Pharmacodynamic Relationship of Intranasally Administered Sufentanil, Ketamine, and CT001
|
Phase 2/Phase 3 | |
Recruiting |
NCT03646955 -
Partial Breast Versus no Irradiation for Women With Early Breast Cancer
|
N/A | |
Active, not recruiting |
NCT03472300 -
Prevalence of Self-disclosed Knee Trouble and Use of Treatments Among Elderly Individuals
|
||
Completed |
NCT03678168 -
A Comparison Between Conventional Throat Packs and Pharyngeal Placement of Tampons in Rhinology Surgeries
|
N/A | |
Completed |
NCT03286543 -
Electrical Stimulation for the Treatment of Pain Following Total Knee Arthroplasty Using the SPRINT Beta System
|
N/A | |
Completed |
NCT03931772 -
Online Automated Self-Hypnosis Program
|
N/A | |
Completed |
NCT02913027 -
Can We Improve the Comfort of Pelvic Exams?
|
N/A | |
Terminated |
NCT02181387 -
Acetaminophen Use in Labor - Does Use of Acetaminophen Reduce Neuraxial Analgesic Drug Requirement During Labor?
|
Phase 4 | |
Recruiting |
NCT06032559 -
Implementation and Effectiveness of Mindfulness Oriented Recovery Enhancement as an Adjunct to Methadone Treatment
|
Phase 3 | |
Active, not recruiting |
NCT03613155 -
Assessment of Anxiety in Patients Treated by SMUR Toulouse and Receiving MEOPA as Part of Their Care
|