At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 226 enrolled
Drug / intervention
supersaturated calcium phosphate rinse +3 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A Randomized Double Blinded Trial of Topical Caphosol to Prevent Oral Mucositis in Children Undergoing Hematopoietic Stem Cell Transplantation
In Brief
A Phase 3 clinical trial evaluating supersaturated calcium phosphate rinse, placebo, and 2 other interventions for Childhood Acute Lymphoblastic Leukemia in Remission and 26 related conditions. Completed, enrolled 226 participants across 35 sites in 3 countries.
Detailed Summary
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.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsChildhood Acute Lymphoblastic Leukemia in Remission, Childhood Acute Myeloid Leukemia in Remission, Childhood Chronic Myelogenous Leukemia, Childhood Myelodysplastic Syndromes, Chronic Eosinophilic Leukemia, Chronic Myelomonocytic Leukemia, Chronic Neutrophilic Leukemia, de Novo Myelodysplastic Syndromes, Disseminated Neuroblastoma, Juvenile Myelomonocytic Leukemia, Mucositis, Myelodysplastic/Myeloproliferative Neoplasm, Unclassifiable, Previously Treated Childhood Rhabdomyosarcoma, Previously Treated Myelodysplastic Syndromes, Recurrent Childhood Acute Lymphoblastic Leukemia, Recurrent Childhood Acute Myeloid Leukemia, Recurrent Childhood Large Cell Lymphoma, Recurrent Childhood Lymphoblastic Lymphoma, Recurrent Childhood Rhabdomyosarcoma, Recurrent Childhood Small Noncleaved Cell Lymphoma, Recurrent Malignant Testicular Germ Cell Tumor, Recurrent Wilms Tumor and Other Childhood Kidney Tumors, Recurrent/Refractory Childhood Hodgkin Lymphoma, Relapsing Chronic Myelogenous Leukemia, Secondary Acute Myeloid Leukemia, Secondary Myelodysplastic Syndromes, Unspecified Childhood Solid Tumor, Protocol Specific
CountriesAustralia, Canada, United States
CollaboratorsNational Cancer Institute (NCI)
Timeline
Phase 3CompletedFinished
2011201220132014201520162017201820192020202120222023202420252026
First PostedFeb 2011
Enrollment StartMar 2011
Primary CompletionJun 2015
Study CompletionJun 2015
TodayJul 2026
First PostedFeb 28, 2011
Enrollment StartMar 1, 2011
Primary CompletionJun 1, 2015
Study CompletionJun 30, 2015
TodayJul 2, 2026
Enrollment to primary: 4.3 yearsPosted 15.3 years ago
Interventions
supersaturated calcium phosphate rinsedrug
Mouth rinse
placeboother
Mouth rinse
questionnaire administrationother
Ancillary studies
quality-of-life assessmentprocedure
Ancillary studies