Supersaturated Calcium Phosphate Rinse in Preventing Oral Mucositis in Young Patients Undergoing Autologous or Donor Stem Cell Transplant

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.

Conditions

• 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

Interventions

DRUG

supersaturated calcium phosphate rinse

Mouth rinse

OTHER

placebo

Mouth rinse

OTHER

questionnaire administration

Ancillary studies

PROCEDURE

quality-of-life assessment

Ancillary studies

Sponsors & Collaborators

• National Cancer Institute (NCI)

  collaborator NIH

• Children's Oncology Group

  lead NETWORK

Principal Investigators

• Nathaniel Treister, MD · Children's Oncology Group

Study Design

Allocation

RANDOMIZED

Purpose

SUPPORTIVE_CARE

Masking

DOUBLE

Model

PARALLEL

Eligibility

Min Age

4 Years

Max Age

21 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2011-03-31

Primary Completion

2015-06-30

Completion

2015-06-30

Countries

• United States
• Australia
• Canada

Study Locations