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


Phase 3
4 Years
21 Years
Open (Enrolling)
Both
Bacterial Infection, Mucositis, Neutropenia

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Trial Information

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


OBJECTIVES:

Primary

- 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

- 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.

- To determine whether Caphosol administration, when compared to placebo, reduces the
incidence of febrile neutropenia and invasive bacterial infections.

- 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 beginning on the first day (about day -7) of the conditioning
regimen.

- Arm II: Patients rinse and gargle with placebo over 1 minute four* times daily
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.

Inclusion Criteria


DISEASE CHARACTERISTICS:

- 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 sources of donor
stem cells:

- HLA-matched family member

- Partially matched family member (mismatched for a single HLA locus at A, B, C,
or DR)

- Fully HLA-matched or partially mismatched unrelated marrow or peripheral blood
stem cell donor (per institutional donor selection standards)

- HLA-matched or partially mismatched (at least 4 of 6 match at A, B, DR) cord
blood

- Patients expecting to receive any type of myeloablative HSCT conditioning regimen are
eligible

- No non-myeloablative or reduced-intensity conditioning regimens

PATIENT CHARACTERISTICS:

- Not pregnant or nursing

- Negative pregnancy test

- Patients must use an effective birth control method

PRIOR CONCURRENT THERAPY:

- See Disease Characteristics

- No palifermin within the past 30 days

- No prior supersaturated calcium phosphate (Caphosol) rinse

- No concurrent intravenous palifermin, topical glutamine, or Gelclair

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Masking: Double-Blind, Primary Purpose: Supportive Care

Outcome Measure:

Duration of severe oral mucositis (WHO Grade 3 or 4)

Safety Issue:

Yes

Principal Investigator

Lillian Sung, MD, PhD

Investigator Role:

Study Chair

Investigator Affiliation:

The Hospital for Sick Children

Authority:

Unspecified

Study ID:

CDR0000695718

NCT ID:

NCT01305200

Start Date:

March 2011

Completion Date:

Related Keywords:

  • Bacterial Infection
  • Mucositis
  • Neutropenia
  • mucositis
  • bacterial infection
  • neutropenia
  • Bacterial Infections
  • Neutropenia
  • Stomatitis
  • Mucositis

Name

Location

Children's Hospital of PhiladelphiaPhiladelphia, Pennsylvania  19104
Mayo Clinic Cancer CenterRochester, Minnesota  55905
University of Chicago Cancer Research CenterChicago, Illinois  60637
New York Medical CollegeValhalla, New York  10595
Lineberger Comprehensive Cancer Center at University of North Carolina - Chapel HillChapel Hill, North Carolina  27599-7570
Children's National Medical CenterWashington, District of Columbia  20010-2970
Miami Children's HospitalMiami, Florida  33155-4069
All Children's HospitalSt. Petersburg, Florida  33701
Children's Memorial Hospital - ChicagoChicago, Illinois  60614
Children's Hospital of New OrleansNew Orleans, Louisiana  70118
City of Hope Comprehensive Cancer CenterDuarte, California  91010
Kosair Children's HospitalLouisville, Kentucky  40202-3830
Midwest Children's Cancer Center at Children's Hospital of WisconsinMilwaukee, Wisconsin  53226
Methodist Children's Hospital of South TexasSan Antonio, Texas  78229-3993
Children's Hospital and Research Center OaklandOakland, California  94609
Rady Children's Hospital - San DiegoSan Diego, California  92123-4282
UCSF Helen Diller Family Comprehensive Cancer CenterSan Francisco, California  94115
AFLAC Cancer Center and Blood Disorders Service of Children's Healthcare of Atlanta - Egleston CampusAtlanta, Georgia  30322
Dana-Farber/Harvard Cancer Center at Dana-Farber Cancer InstituteBoston, Massachusetts  02115
C.S. Mott Children's Hospital at University of Michigan Medical CenterAnn Arbor, Michigan  48109-0286
University of Mississippi Cancer ClinicJackson, Mississippi  39216-4505
Nationwide Children's HospitalColumbus, Ohio  43205-2696
Oklahoma University Cancer InstituteOklahoma City, Oklahoma  73104
Children's Hospital of Pittsburgh of UPMCPittsburgh, Pennsylvania  15213
Riley's Children Cancer Center at Riley Hospital for ChildrenIndianapolis, Indiana  46202-5225