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

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ClinicalTrials.gov Identifier: NCT01305200
Recruitment Status : Completed
First Posted : February 28, 2011
Results First Posted : May 9, 2017
Last Update Posted : May 9, 2017
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Children's Oncology Group

Brief 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.

Condition or disease Intervention/treatment Phase
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 Drug: supersaturated calcium phosphate rinse Other: placebo Other: questionnaire administration Procedure: quality-of-life assessment Phase 3

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.


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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 226 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Care Provider)
Primary Purpose: Supportive Care
Official Title: A Randomized Double Blinded Trial of Topical Caphosol to Prevent Oral Mucositis in Children Undergoing Hematopoietic Stem Cell Transplantation
Study Start Date : March 2011
Actual Primary Completion Date : June 2015
Actual Study Completion Date : June 30, 2015


Arm Intervention/treatment
Placebo Comparator: Arm I (placebo)
Patients rinse and gargle with placebo over 1 minute QID beginning the first day (about day -7) of the conditioning regimen. Treatment continues until day 20 post-transplantation.
Other: placebo
Mouth rinse
Other Name: PLCB

Other: questionnaire administration
Ancillary studies

Procedure: quality-of-life assessment
Ancillary studies
Other Name: quality of life assessment

Experimental: Arm II (supersaturated calcium phosphate rinse)
Patients rinse and gargle with supersaturated calcium phosphate rinse over 1 minute QID beginning on the first day (about day -7) of the conditioning regimen. Treatment continues until day 20 post-transplantation.
Drug: supersaturated calcium phosphate rinse
Mouth rinse
Other Name: Caphosol

Other: questionnaire administration
Ancillary studies

Procedure: quality-of-life assessment
Ancillary studies
Other Name: quality of life assessment




Primary Outcome Measures :
  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 Outcome Measures :
  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 Outcome Measures:
  1. Ancillary Validation Study of ChIMES [ Time Frame: Day -1 (day prior to stem cell infusion) to Day 20 following transplantation. ]


Information from the National Library of Medicine

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Ages Eligible for Study:   4 Years to 21 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01305200


  Hide Study Locations
Locations
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United States, California
Children's Oncology Group
Arcadia, California, United States, 91006-3776
City of Hope
Duarte, California, United States, 91010
Children's Hospital and Research Center at Oakland
Oakland, California, United States, 94609-1809
Rady Children's Hospital - San Diego
San Diego, California, United States, 92123
University of California San Francisco Medical Center-Parnassus
San Francisco, California, United States, 94143
United States, Delaware
Alfred I duPont Hospital for Children
Wilmington, Delaware, United States, 19803
United States, District of Columbia
Children's National Medical Center
Washington, District of Columbia, United States, 20010
United States, Florida
Miami Children's Hospital
Miami, Florida, United States, 33155
All Children's Hospital
Saint Petersburg, Florida, United States, 33701
United States, Georgia
Children's Healthcare of Atlanta - Egleston
Atlanta, Georgia, United States, 30322
United States, Illinois
Lurie Children's Hospital-Chicago
Chicago, Illinois, United States, 60614
University of Chicago
Chicago, Illinois, United States, 60637
United States, Indiana
Riley Hospital for Children
Indianapolis, Indiana, United States, 46202
United States, Kentucky
Kosair Children's Hospital
Louisville, Kentucky, United States, 40202
United States, Louisiana
Children's Hospital-Main Campus
New Orleans, Louisiana, United States, 70118
United States, Massachusetts
Floating Hospital for Children at Tufts Medical Center
Boston, Massachusetts, United States, 02111
Dana-Farber Cancer Institute
Boston, Massachusetts, United States, 02115
United States, Michigan
C S Mott Children's Hospital
Ann Arbor, Michigan, United States, 48109
United States, Minnesota
Mayo Clinic
Rochester, Minnesota, United States, 55905
United States, Mississippi
University of Mississippi Medical Center
Jackson, Mississippi, United States, 39216
United States, Missouri
The Childrens Mercy Hospital
Kansas City, Missouri, United States, 64108
United States, Nebraska
University of Nebraska Medical Center
Omaha, Nebraska, United States, 68198
United States, New York
Montefiore Medical Center
Bronx, New York, United States, 10467-2490
Columbia University Medical Center
New York, New York, United States, 10032
Ny Cancer%
Valhalla, New York, United States, 10595
United States, Ohio
Nationwide Children's Hospital
Columbus, Ohio, United States, 43205
United States, Oklahoma
University of Oklahoma Health Sciences Center
Oklahoma City, Oklahoma, United States, 73104
United States, Pennsylvania
Children's Hospital of Philadelphia
Philadelphia, Pennsylvania, United States, 19104
Children's Hospital of Pittsburgh of UPMC
Pittsburgh, Pennsylvania, United States, 15224
United States, Texas
Methodist Children's Hospital of South Texas
San Antonio, Texas, United States, 78229
United States, Wisconsin
Midwest Children's Cancer Center
Milwaukee, Wisconsin, United States, 53226
Australia, Queensland
Royal Childrens Hospital
Herston, Queensland, Australia, 4029
Australia, Western Australia
Princess Margaret Hospital for Children
Perth, Western Australia, Australia, 6008
Canada, Ontario
Hospital for Sick Children
Toronto, Ontario, Canada, M5G 1X8
Canada, Quebec
The Montreal Children's Hospital of the MUHC
Montreal, Quebec, Canada, H3H 1P3
Sponsors and Collaborators
Children's Oncology Group
National Cancer Institute (NCI)
Investigators
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Principal Investigator: Nathaniel Treister, MD Children's Oncology Group

Publications:
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Responsible Party: Children's Oncology Group
ClinicalTrials.gov Identifier: NCT01305200     History of Changes
Other Study ID Numbers: ACCL1031
NCI-2011-02635 ( Registry Identifier: CTRP (Clinical Trial Reporting Program) )
CDR0000695718 ( Other Identifier: Clinical Trials.gov )
ACCL1031 ( Other Identifier: Children's Oncology Group )
COG-ACCL1031 ( Other Identifier: DCP )
ACCL1031 ( Other Identifier: CTEP )
U10CA095861 ( U.S. NIH Grant/Contract )
First Posted: February 28, 2011    Key Record Dates
Results First Posted: May 9, 2017
Last Update Posted: May 9, 2017
Last Verified: November 2016

Additional relevant MeSH terms:
Layout table for MeSH terms
Lymphoma
Syndrome
Leukemia
Leukemia, Myeloid
Leukemia, Myeloid, Acute
Myelodysplastic Syndromes
Preleukemia
Neoplasm Metastasis
Precursor Cell Lymphoblastic Leukemia-Lymphoma
Leukemia, Lymphoid
Hodgkin Disease
Leukemia, Myelogenous, Chronic, BCR-ABL Positive
Neuroblastoma
Neoplasms, Germ Cell and Embryonal
Leukemia, Myelomonocytic, Acute
Leukemia, Myelomonocytic, Chronic
Mucositis
Rhabdomyosarcoma
Leukemia, Myelomonocytic, Juvenile
Myeloproliferative Disorders
Stomatitis
Lymphoma, Non-Hodgkin
Testicular Neoplasms
Wilms Tumor
Rhabdomyosarcoma, Embryonal
Myelodysplastic-Myeloproliferative Diseases
Hypereosinophilic Syndrome
Leukemia, Neutrophilic, Chronic
Kidney Neoplasms
Neoplasms by Histologic Type