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

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

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

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.

Detailed Summary:

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 fir
Sponsor: Children's Oncology Group

Current Primary Outcome: 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.


Original Primary Outcome: Duration of Severe Oral Mucositis (WHO Grade 3 or 4)

Current Secondary Outcome:

  • 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.
  • 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
  • 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
  • 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.
  • 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
  • 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
  • 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.
  • Incidence of Febrile Neutropenia [ Time Frame: Day -1 (day prior to stem cell infusion) to Day 20 following transplantation. ]
    Fever and Neutropenia = yes
  • Incidence of Invasive Bacterial Infections [ Time Frame: Day -1 (day prior to stem cell infusion) to Day 20 following transplantation. ]
    Invasive Bacterial Infection = yes
  • 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.


Original Secondary Outcome:

  • Incidence of severe oral mucositis (WHO grade 3 or 4)
  • Severity of mucositis according to pain categorical rating scale and modified OMDQ
  • Incidence, total dose, and duration of parenteral opioid analgesic use
  • Incidence and duration of TPN use
  • Incidence of Febrile Neutropenia
  • Incidence of Invasive Bacterial Infections
  • ChIMES score


Information By: Children's Oncology Group

Dates:
Date Received: February 25, 2011
Date Started: March 2011
Date Completion:
Last Updated: March 28, 2017
Last Verified: November 2016