Clinical trial · Interventional
Supersaturated Calcium Phosphate Rinse in Preventing Oral Mucositis in Young Patients Undergoing Autologous or Donor Stem Cell Transplant
A Randomized Double Blinded Trial of Topical Caphosol to Prevent Oral Mucositis in Children Undergoing Hematopoietic Stem Cell Transplantation
NCT01305200CI-TRIAL-00040641completedPhase 3Results postedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (27)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Childhood Acute Lymphoblastic Leukemia in Remission | Childhood Acute Lymphoblastic Leukemia | CURATED_BROADER | 0.78 |
| Childhood Acute Myeloid Leukemia in Remission | Childhood Acute Myeloid Leukemia | CURATED_BROADER | 0.80 |
| Childhood Chronic Myelogenous Leukemia | Childhood Chronic Myeloid Leukemia, BCR-ABL1 Positive | ALIAS | 0.90 |
| Childhood Myelodysplastic Syndromes | Myelodysplastic Syndrome | ALIAS | 0.85 |
| Chronic Eosinophilic Leukemia | Chronic Eosinophilic Leukemia, Not Otherwise Specified | ONTOLOGY_EXACT | 0.98 |
| Chronic Myelomonocytic Leukemia | Chronic Myelomonocytic Leukemia | ONTOLOGY_EXACT | 0.98 |
| Chronic Neutrophilic Leukemia | Chronic Neutrophilic Leukemia | ONTOLOGY_EXACT | 0.98 |
| de Novo Myelodysplastic Syndromes |
Interventions
Interventions (4)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| placebo | Other | — | UNRESOLVED |
| quality-of-life assessment | Procedure | — | UNRESOLVED |
| questionnaire administration | Other | — | UNRESOLVED |
| supersaturated calcium phosphate rinse | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- PLACEBO_COMPARATOR
- label
- Arm I (placebo)
- description
- Patients rinse and gargle with placebo over 1 minute QID beginning the first day (about day -7) of the conditioning regimen. Treatment continues until day 20 post-transplantation.
- interventionNames
- Other: placebo
- Other: questionnaire administration
- Procedure: quality-of-life assessment
- type
- EXPERIMENTAL
- label
- Arm II (supersaturated calcium phosphate rinse)
- description
- Patients rinse and gargle with supersaturated calcium phosphate rinse over 1 minute QID beginning on the first day (about day -7) of the conditioning regimen. Treatment continues until day 20 post-transplantation.
- interventionNames
- Drug: supersaturated calcium phosphate rinse
- Other: questionnaire administration
- Procedure: quality-of-life assessment
Primary outcomes (1)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 4 Years
- Maximum age
- 21 Years
Show eligibility criteria text
Inclusion Criteria: * Patients undergoing myeloablative autologous or allogeneic hematopoietic stem cell transplantation (HSCT) for any indication * One or more of the following donor stem cell sources (autologous or allogeneic): * Bone marrow * Placental blood (umbilical cord blood) * Cytokine-mobilized peripheral blood * Patients eligible for allogeneic HSCT must have one of the following types of donor stem cells: * Human leukocyte antigen (HLA)-matched sibling or parent * Partially matched family donor (mismatched for a single HLA locus \[Class I\]) * Fully matched unrelated marrow or peripheral blood stem cell donor * HLA-matched or partially mismatched (at least 4 of 6 match) cord blood (Class I or II) * Patients expecting to receive any type of myeloablative HSCT conditioning regimen are eligible * No non-myeloablative or reduced-intensity conditioning regimens * Eligible patients must not have received palifermin within 30 days prior to enrollment * Eligible patients must not have received prior treatment with Caphosol Exclusion Criteria: * Females of childbearing potential must have a negative pregnancy test; patients must agree to use an effective birth control method; lactating patients must agree not to nurse a child while on this trial
References
Publications (1)
- BACKGROUNDTreister N, Nieder M, Baggott C, Olson E, Chen L, Dang H, Krailo M, August A, Sung L. Caphosol for prevention of oral mucositis in pediatric myeloablative haematopoietic cell transplantation. Br J Cancer. 2017 Jan 3;116(1):21-27. doi: 10.1038/bjc.2016.380. Epub 2016 Nov 22. PMID 27875526