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Myeloproliferative Neoplasm, Testicular, Soft Tissue Sarcoma, Kidney, Mucositis, Lymphoma (Hodgkins), Neuroblastoma, Leukemia, Lymphoma (Non-Hodgkins), and Myelodysplastic Syndrome (MDS)

A Randomized Double Blinded Trial of Topical Caphosol to Prevent Oral Mucositis in Children Undergoing Hematopoietic Stem Cell Transplantation

Unique Data Set IDnci-data-1
DownloadableNo
SponsorChildren's Oncology GroupData ProviderNCITotal Study Enrolled Patients226RandomizationYesPubMed (PMID)27875526.00ClinicalTrial.gov IDNCT01305200ClinicalTrial.gov URLhttps://clinicaltrials.gov/ct2/show/NCT01305200
Study PhaseClinical Study Phase IIIBlinding MethodDouble-BlindedType(s) of dataN/AIntervention TypeDrug, Best Supportive Car, Other, PlaceboData Set TypeOther

Clinical Trial Title

A Randomized Double Blinded Trial of Topical Caphosol to Prevent Oral Mucositis in Children Undergoing Hematopoietic Stem Cell Transplantation

Trial Summary and Conditions

This randomized phase III trial is studying how well Caphosol rinse works in preventing mucositis in young patients undergoing autologous or donor stem cell transplant. Supersaturated calcium phosphate (Caphosol) rinse may be able to prevent mucositis, or mouth sores, in patients undergoing stem cell transplant.

Data Summary

See data dictionary for more details.

Study Objectives

PRIMARY OBJECTIVES: I. To determine if topically administered supersaturated calcium phosphate (Caphosol), rinsed orally four times daily at the initiation of conditioning for hematopoietic stem cell transplantation (HSCT), reduces oral mucositis as demonstrated by a decrease in duration of severe oral mucositis (World Health Organization [WHO] grade 3 or 4), compared to placebo. SECONDARY OBJECTIVES: I. To determine whether Caphosol administration, when compared to placebo, reduces oral mucositis as demonstrated by a decrease in incidence of severe oral mucositis (WHO grade 3 or 4); severity of mucositis according to mouth pain categorical rating scale and Oral Mucositis Daily Questionnaire (OMDQ); incidence, total dose, and duration of parenteral opioid analgesic use (morphine equivalents); and incidence and duration of total parenteral nutrition (TPN) administration. II. To determine whether Caphosol administration, when compared to placebo, reduces the incidence of febrile neutropenia and invasive bacterial infections. III. To validate a new pediatric measure of oral mucositis termed the Children's International Mucositis Evaluation Scale (ChIMES). OUTLINE: This is a multicenter study. Patients are stratified according to conditioning regimen (total-body irradiation (TBI) or melphalan vs neither TBI nor melphalan) and hematopoietic stem cell transplantation (HSCT) (autologous vs allogeneic). Patients are randomized to 1 of 2 treatment arms. ARM I: Patients rinse and gargle with supersaturated calcium phosphate rinse over 1 minute four* times daily (QID) beginning on the first day (about day -7) of the conditioning regimen. ARM II: Patients rinse and gargle with placebo over 1 minute QID* beginning the first day (about day -7) of the conditioning regimen.

Outcome Measures

Primary: Duration of severe oral mucositis (WHO grade 3 or 4) [ Time Frame: Up to day 20 ] Secondary: Incidence of severe oral mucositis (WHO grade 3 or 4) [ Time Frame: Up to day 20 ] Severity of mucositis according to pain categorical rating scale and modified OMDQ [ Time Frame: Up to day 20 ] Incidence, total dose, and duration of parenteral opioid analgesic use [ Time Frame: Up to day 20 ] Incidence and duration of TPN use [ Time Frame: Up to day 20 ] Incidence of febrile neutropenia [ Time Frame: Up to day 20 ] Incidence of invasive bacterial infections [ Time Frame: Up to day 20 ]

ClinicalTrial.gov

Below are the clinical trial(s) associated with this dataset (all links are to ClinicalTrials.Gov):

Available Downloads:

To gain access to the data and analytic tools click here.

Data Dictionary: NCT01305200-D1-Data-Dictionary.pdf

DATA: NCT01305200-D1-Dataset.csv

OTHER: README.pdf