Phase 3
N=226
Supersaturated Calcium Phosphate Rinse in Preventing Oral Mucositis in Young Patients Undergoing Autologous or Donor Stem Cell Transplant
Childhood Acute Lymphoblastic Leukemia in Remission · Childhood Acute Myeloid Leukemia in Remission · Childhood Chronic Myelogenous Leukemia · Childhood Myelodysplastic Syndromes · Chronic Eosinophilic Leukemia
Bottom Line
View on ClinicalTrials.gov: NCT01305200 ↗Enrolled (actual)
226
Serious AEs
1.4%
Results posted
May 2017
Primary outcome: Primary: Duration of Severe Oral Mucositis (WHO Grade 3 or 4) — 4.5; 4.5 Number of days
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- supersaturated calcium phosphate rinse (Drug); placebo (Other); questionnaire administration (Other); quality-of-life assessment (Procedure)
- Age
- Pediatric, Adult · 4+ yrs
- Sex
- All
- Sponsor
- Children's Oncology Group
- Primary completion
- Jun 2015
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Duration of Severe Oral Mucositis (WHO Grade 3 or 4) |
4.5; 4.5 | — |
| SECONDARY Incidence of Severe Oral Mucositis |
68; 63 | — |
| SECONDARY Oral Mucositis Daily Questionnaire (OMDQ) |
9.3; 7.3; 22.3; 21.4; 21.4; 19.9 | — |
| SECONDARY Incidence of Parenteral Opioid Analgesic Use (Morphine Equivalents). |
88.7; 91.3 | — |
| SECONDARY Duration of Parenteral Opioid Analgesic Use (Morphine Equivalents). |
14.2; 12.5 | — |
| SECONDARY Total Dose of Parenteral Opioid Analgesic Used (Morphine Equivalents). |
0.4; 0.3 | — |
| SECONDARY Incidence of Total Parenteral Nutrition (TPN) Administration. |
78.3; 72.1 | — |
| SECONDARY Duration of Total Parenteral Nutrition (TPN) Administration. |
13.6; 11.4 | — |
| SECONDARY Incidence of Febrile Neutropenia |
65.1; 67.3 | — |
| SECONDARY Incidence of Invasive Bacterial Infections |
6.6; 7.7 | — |
| SECONDARY Severity of Mucositis |
45.5; 44 | — |
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.
Eligibility Criteria
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
Data sourced from ClinicalTrials.gov (NCT01305200). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.