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NCT Number: NCT01305200

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

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.

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Key information

Conditions

Childhood Acute Lymphoblastic Leukemia in Remission Bone Marrow Diseases Burkitt Lymphoma Childhood Acute Myeloid Leukemia in Remission Childhood Chronic Myelogenous Leukemia Childhood Myelodysplastic Syndromes Chronic Disease Chronic Eosinophilic Leukemia Chronic Myelomonocytic Leukemia Chronic Neutrophilic Leukemia Congenital, Hereditary, and Neonatal Diseases and Abnormalities DNA Virus Infections Dendritic Cell Sarcoma, Interdigitating Digestive System Diseases Disease Attributes Disseminated Neuroblastoma Endocrine Gland Neoplasms Endocrine System Diseases Epstein-Barr Virus Infections Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Gastroenteritis Gastrointestinal Diseases Genetic Diseases, Inborn Genital Diseases Genital Diseases, Male Genital Neoplasms, Male Gonadal Disorders Hematologic Diseases Hemic and Lymphatic Diseases Herpesviridae Infections Histiocytic Disorders, Malignant Histiocytosis Immune System Diseases Immunoproliferative Disorders Infections Juvenile Myelomonocytic Leukemia Kidney Diseases Kidney Neoplasms Leukemia Leukemia, Lymphoid Leukemia, Myeloid Leukemia, Myelomonocytic, Chronic Leukemia, Myelomonocytic, Juvenile Leukemia, Neutrophilic, Chronic Lymphatic Diseases Lymphoma Lymphoma, B-Cell Lymphoma, Non-Hodgkin Lymphoproliferative Disorders Male Urogenital Diseases Mouth Diseases Mucositis Myelodysplastic-Myeloproliferative Diseases Myelodysplastic/Myeloproliferative Neoplasm, Unclassifiable Myeloproliferative Disorders Neoplasms Neoplasms by Histologic Type Neoplasms by Site Neoplasms, Complex and Mixed Neoplastic Syndromes, Hereditary Pathologic Processes Pathological Conditions, Signs and Symptoms Pdgfra-Associated Chronic Eosinophilic Leukemia Precursor Cell Lymphoblastic Leukemia-Lymphoma Previously Treated Childhood Rhabdomyosarcoma Previously Treated Myelodysplastic Syndromes Recurrence 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 Stomatognathic Diseases Testicular Diseases Testicular Neoplasms Tumor Virus Infections Unspecified Childhood Solid Tumor, Protocol Specific Urogenital Diseases Urogenital Neoplasms Urologic Diseases Urologic Neoplasms Virus Diseases Wilms Tumor de Novo Myelodysplastic Syndromes

Age range

4 year–21 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Royal Childrens Hospital, Herston, Queensland, Australia

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

supersaturated calcium phosphate rinse

Drug

Mouth rinse

Other names: Caphosol

Placebo

Other

Mouth rinse

Other names: PLCB

Questionnaire Administration

Other

Ancillary studies

quality-of-life assessment

Procedure

Ancillary studies

Other names: quality of life assessment

Primary outcomes

  1. Duration of Severe Oral Mucositis (WHO Grade 3 or 4)

    Time frame: Day -1 (day prior to stem cell infusion) to Day 20 following transplantation.

    Mean days of severe (WHO Grade 3 or 4) Mucositis.

Secondary outcomes

  1. Incidence of Severe Oral Mucositis

    Time frame: Day -1 (day prior to stem cell infusion) to Day 20 following transplantation.

    Percentage of patients with Severe Oral Mucositis (WHO Grade 3 or 4) per arm.

  2. Oral Mucositis Daily Questionnaire (OMDQ)

    Time frame: Day -1 (day prior to stem cell infusion) to Day 20 following transplantation

    Area under the curve (AUC) of the Oral Mucositis Daily Questionnaire (OMDQ) subscales

  3. Incidence of Parenteral Opioid Analgesic Use (Morphine Equivalents).

    Time frame: Day -1 (day prior to stem cell infusion) to Day 20 following transplantation.

    Opioid Administration = yes

  4. Duration of Parenteral Opioid Analgesic Use (Morphine Equivalents).

    Time frame: Day -1 (day prior to stem cell infusion) to Day 20 following transplantation.

    Mean days of parenteral opioid analgesic use.

  5. Total Dose of Parenteral Opioid Analgesic Used (Morphine Equivalents).

    Time frame: Day -1 (day prior to stem cell infusion) to Day 20 following transplantation.

    Morphine equivalent dose in mg/kg/day

  6. Incidence of Total Parenteral Nutrition (TPN) Administration.

    Time frame: Day -1 (day prior to stem cell infusion) to Day 20 following transplantation.

    Total Parenteral Nutrition = yes

  7. Duration of Total Parenteral Nutrition (TPN) Administration.

    Time frame: Day -1 (day prior to stem cell infusion) to Day 20 following transplantation.

    Mean days of total parenteral nutrition (TPN) administration.

  8. Incidence of Febrile Neutropenia

    Time frame: Day -1 (day prior to stem cell infusion) to Day 20 following transplantation.

    Fever and Neutropenia = yes

  9. Incidence of Invasive Bacterial Infections

    Time frame: Day -1 (day prior to stem cell infusion) to Day 20 following transplantation.

    Invasive Bacterial Infection = yes

  10. Severity of Mucositis

    Time frame: Day -1 (day prior to stem cell infusion) to Day 20 following transplantation

    Area Under the Curve of Severity of Mucositis. According to mouth pain categorical rating scale ranges 0-10 with higher scores reflecting more severe pain.

Other outcomes

  1. Ancillary Validation Study of ChIMES

    Time frame: Day -1 (day prior to stem cell infusion) to Day 20 following transplantation.

Sponsors and collaborators

Lead sponsor

Children's Oncology Group

Network

Collaborators

  • National Cancer Institute (NCI)

Registry information

Official study title

A Randomized Double Blinded Trial of Topical Caphosol to Prevent Oral Mucositis in Children Undergoing Hematopoietic Stem Cell Transplantation

Important dates

Study start
2011
Primary completion
2015
Study completion
2015
First posted
Feb 28, 2011
Registry last updated
Sep 17, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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