NCT01305200 · REGISTRY CONDITION SEARCH

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

Found through the registry condition index, not selected as a treatment recommendation. This discovery collection was restricted to studies with posted results.

Phase: PHASE3
Status at capture: COMPLETED
Registry last update: 2019-09-17

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.

Open the original ClinicalTrials.gov record → · Download preserved record

What did the study report?

Outcomes, safety and baseline populations are separate source sections. Quality-of-life measures appear under their original outcome titles.

flow

Participant flow

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baseline

Baseline characteristics

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outcome · POSTED

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

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outcome · POSTED

Incidence of Severe Oral Mucositis

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outcome · POSTED

Oral Mucositis Daily Questionnaire (OMDQ)

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outcome · POSTED

Incidence of Parenteral Opioid Analgesic Use (Morphine Equivalents).

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outcome · POSTED

Duration of Parenteral Opioid Analgesic Use (Morphine Equivalents).

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outcome · POSTED

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

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outcome · POSTED

Incidence of Total Parenteral Nutrition (TPN) Administration.

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outcome · POSTED

Duration of Total Parenteral Nutrition (TPN) Administration.

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outcome · POSTED

Incidence of Febrile Neutropenia

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outcome · POSTED

Incidence of Invasive Bacterial Infections

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outcome · POSTED

Severity of Mucositis

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outcome · POSTED

Ancillary Validation Study of ChIMES

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adverse events

Adverse events

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more info

Limitations, agreements, and source contact

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Who could take part

eligibility 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
healthy Volunteers: false
maximum Age: 21 Years
minimum Age: 4 Years
sex: ALL
std Ages: CHILD
ADULT

Treatment arms and interventions

arm Groups

description
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.
intervention Names
Other: placebo
Other: questionnaire administration
Procedure: quality-of-life assessment
label
Arm I (placebo)
type
PLACEBO_COMPARATOR
description
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.
intervention Names
Drug: supersaturated calcium phosphate rinse
Other: questionnaire administration
Procedure: quality-of-life assessment
label
Arm II (supersaturated calcium phosphate rinse)
type
EXPERIMENTAL

interventions

arm Group Labels
Arm II (supersaturated calcium phosphate rinse)
description
Mouth rinse
name
supersaturated calcium phosphate rinse
other Names
Caphosol
type
DRUG
arm Group Labels
Arm I (placebo)
description
Mouth rinse
name
placebo
other Names
PLCB
type
OTHER
arm Group Labels
Arm I (placebo)
Arm II (supersaturated calcium phosphate rinse)
description
Ancillary studies
name
questionnaire administration
type
OTHER
arm Group Labels
Arm I (placebo)
Arm II (supersaturated calcium phosphate rinse)
description
Ancillary studies
name
quality-of-life assessment
other Names
quality of life assessment
type
PROCEDURE

Study design

allocation

RANDOMIZED

intervention Model

PARALLEL

masking Info

masking: DOUBLE
who Masked: PARTICIPANT
CARE_PROVIDER

primary Purpose

SUPPORTIVE_CARE

Enrollment

count: 226
type: ACTUAL

Registered outcome plans (not posted results)

other Outcomes

measure
Ancillary Validation Study of ChIMES
time Frame
Day -1 (day prior to stem cell infusion) to Day 20 following transplantation.

primary Outcomes

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

secondary Outcomes

description
Percentage of patients with Severe Oral Mucositis (WHO Grade 3 or 4) per arm.
measure
Incidence of Severe Oral Mucositis
time Frame
Day -1 (day prior to stem cell infusion) to Day 20 following transplantation.
description
Area under the curve (AUC) of the Oral Mucositis Daily Questionnaire (OMDQ) subscales
measure
Oral Mucositis Daily Questionnaire (OMDQ)
time Frame
Day -1 (day prior to stem cell infusion) to Day 20 following transplantation
description
Opioid Administration = yes
measure
Incidence of Parenteral Opioid Analgesic Use (Morphine Equivalents).
time Frame
Day -1 (day prior to stem cell infusion) to Day 20 following transplantation.
description
Mean days of parenteral opioid analgesic use.
measure
Duration of Parenteral Opioid Analgesic Use (Morphine Equivalents).
time Frame
Day -1 (day prior to stem cell infusion) to Day 20 following transplantation.
description
Morphine equivalent dose in mg/kg/day
measure
Total Dose of Parenteral Opioid Analgesic Used (Morphine Equivalents).
time Frame
Day -1 (day prior to stem cell infusion) to Day 20 following transplantation.
description
Total Parenteral Nutrition = yes
measure
Incidence of Total Parenteral Nutrition (TPN) Administration.
time Frame
Day -1 (day prior to stem cell infusion) to Day 20 following transplantation.
description
Mean days of total parenteral nutrition (TPN) administration.
measure
Duration of Total Parenteral Nutrition (TPN) Administration.
time Frame
Day -1 (day prior to stem cell infusion) to Day 20 following transplantation.
description
Fever and Neutropenia = yes
measure
Incidence of Febrile Neutropenia
time Frame
Day -1 (day prior to stem cell infusion) to Day 20 following transplantation.
description
Invasive Bacterial Infection = yes
measure
Incidence of Invasive Bacterial Infections
time Frame
Day -1 (day prior to stem cell infusion) to Day 20 following transplantation.
description
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.
measure
Severity of Mucositis
time Frame
Day -1 (day prior to stem cell infusion) to Day 20 following transplantation

Full study description

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 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.

Source references

references

citation
Treister N, Nieder M, Baggott C, Olson E, Chen L, Dang H, Krailo M, August A, Sung L. Caphosol for prevention of oral mucositis in pediatric myeloablative haematopoietic cell transplantation. Br J Cancer. 2017 Jan 3;116(1):21-27. doi: 10.1038/bjc.2016.380. Epub 2016 Nov 22.
pmid
27875526
type
BACKGROUND