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 |
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Recruitment Status :
Completed
First Posted : February 28, 2011
Results First Posted : May 9, 2017
Last Update Posted : September 17, 2019
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| 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 |
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.
| 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 |
|---|---|
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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.
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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 |
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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.
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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 |
- 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.
- 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.
- Ancillary Validation Study of ChIMES [ Time Frame: Day -1 (day prior to stem cell infusion) to Day 20 following transplantation. ]
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| Ages Eligible for Study: | 4 Years to 21 Years (Child, Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- Patients undergoing myeloablative autologous or allogeneic hematopoietic stem cell transplantation (HSCT) for any indication
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One or more of the following donor stem cell sources (autologous or allogeneic):
- Bone marrow
- Placental blood (umbilical cord blood)
- Cytokine-mobilized peripheral blood
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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)
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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
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
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| Principal Investigator: | Nathaniel Treister, MD | Children's Oncology Group |
Publications:
| Responsible Party: | Children's Oncology Group |
| ClinicalTrials.gov Identifier: | NCT01305200 |
| 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: | September 17, 2019 |
| Last Verified: | November 2016 |
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Lymphoma Leukemia Leukemia, Myeloid Leukemia, Myeloid, Acute Preleukemia Neoplasm Metastasis Precursor Cell Lymphoblastic Leukemia-Lymphoma Leukemia, Lymphoid Leukemia, Myelogenous, Chronic, BCR-ABL Positive Neuroblastoma Leukemia, Myelomonocytic, Acute Leukemia, Myelomonocytic, Chronic Rhabdomyosarcoma Leukemia, Myelomonocytic, Juvenile Lymphoma, Non-Hodgkin |
Wilms Tumor Rhabdomyosarcoma, Embryonal Testicular Neoplasms Mucositis Stomatitis Myelodysplastic Syndromes Myeloproliferative Disorders Myelodysplastic-Myeloproliferative Diseases Hypereosinophilic Syndrome Leukemia, Neutrophilic, Chronic Syndrome Neoplasms by Histologic Type Neoplasms Lymphoproliferative Disorders Lymphatic Diseases |