Supersaturated Calcium Phosphate Rinse in Preventing Oral Mucositis in Young Patients Undergoing Autologous or Donor Stem Cell Transplant
Condition: Childhood 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
MeSH terms: Lymphoma; Leukemia; Leukemia, Myeloid; Leukemia, Myeloid, Acute; Preleukemia; Neoplasm Metastasis; Precursor Cell Lymphoblastic Leukemia-Lymphoma; Leukemia, Lymphoid; Leukemia, Myelogenous, Chronic, BCR-ABL Positive; Neuroblastoma; Leukemia, Myelomonocytic, Acute; Leukemia, Myelomonocytic, Chronic; Rhabdomyosarcoma; Leukemia, Myelomonocytic, Juvenile; Lymphoma, Non-Hodgkin; Wilms Tumor; Rhabdomyosarcoma, Embryonal; Testicular Neoplasms; Mucositis; Stomatitis; Myelodysplastic Syndromes; Myeloproliferative Disorders; Myelodysplastic-Myeloproliferative Diseases; Hypereosinophilic Syndrome; Leukemia, Neutrophilic, Chronic; Syndrome; Recurrence
Intervention: supersaturated calcium phosphate rinse; placebo; questionnaire administration; quality-of-life assessment
Intervention description: Mouth rinse; Mouth rinse; Ancillary studies; Ancillary studies
Intervention MeSH terms: Calcium
Phase: Phase 3
Study type: Interventional
Primary purpose: Supportive Care
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Care Provider)
Enrollment: 226.0
Sex: All
Minimum age: 4 Years
Maximum age: 21 Years
Healthy volunteers: No

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