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
Study type: Interventional
Phase: Phase 3

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.
    

Detailed description: 
      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.

      NOTE: * Patients who reach WHO grade 3 or 4 mucositis have the option to request a total of 6
      rinses daily.

      In both arms, treatment continues until day 20 post-transplantation OR until mucositis
      resolves to WHO grade =< 2 for two consecutive days OR on day 12 in patients who do not
      experience oral mucositis of at least WHO grade >= 1. Patients are assessed daily by trained
      healthcare professionals using the Oral Mucositis Daily Questionnaire (OMDQ), the Pain Rating
      Scale, the WHO Mucositis Scale, and the Children's International Mucositis Evaluation Scale
      (ChIMES) from day -1 and continuing until day 20. Patients are also observed for the
      incidence of total dose and duration of parenteral opioid analgesic use, duration of total
      parenteral nutrition (TPN) administration, febrile neutropenia, and invasive bacterial
      infections.

      After completion of study therapy, patients are followed up for 30 days.
    

Intervention name(s): supersaturated calcium phosphate rinse; placebo; questionnaire administration; quality-of-life assessment
Intervention type(s): Drug; Other; Other; Procedure
Intervention description(s): Mouth rinse; Mouth rinse; Ancillary studies; Ancillary studies
Other intervention name(s): Caphosol; PLCB; quality of life assessment
Intervention MeSH terms: Calcium
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Care Provider)
Primary purpose: Supportive Care