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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01305200
First Posted: February 28, 2011
Last Update Posted: May 9, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Children's Oncology Group
Results First Submitted: November 30, 2016  
Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Double (Participant, Care Provider);   Primary Purpose: Supportive Care
Conditions: 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
Interventions: Drug: supersaturated calcium phosphate rinse
Other: placebo
Other: questionnaire administration
Procedure: quality-of-life assessment

  Participant Flow
  Hide Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
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.

placebo: Mouth rinse

questionnaire administration: Ancillary studies

quality-of-life assessment: Ancillary studies

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.

supersaturated calcium phosphate rinse: Mouth rinse

questionnaire administration: Ancillary studies

quality-of-life assessment: Ancillary studies

Arm III (Enrolled But Not Randomized) Site not randomized

Participant Flow:   Overall Study
    Arm I (Placebo)   Arm II (Supersaturated Calcium Phosphate Rinse)   Arm III (Enrolled But Not Randomized)
STARTED   111   112   3 
COMPLETED   82   81   0 
NOT COMPLETED   29   31   3 
Physician Decision                4                6                1 
Withdrawal by Subject                24                21                1 
Ineligible                1                2                1 
Death                0                2                0 



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
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.

placebo: Mouth rinse

questionnaire administration: Ancillary studies

quality-of-life assessment: Ancillary studies

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.

supersaturated calcium phosphate rinse: Mouth rinse

questionnaire administration: Ancillary studies

quality-of-life assessment: Ancillary studies

Arm III (Enrolled Not Randomized) Site not able to randomize.
Total Total of all reporting groups

Baseline Measures
   Arm I (Placebo)   Arm II (Supersaturated Calcium Phosphate Rinse)   Arm III (Enrolled Not Randomized)   Total 
Overall Participants Analyzed 
[Units: Participants]
 111   112   3   226 
Age 
[Units: Years]
Mean (Standard Deviation)
 12.75  (5.05)   13.02  (4.54)   12.00  (1.73)   12.88  (4.79) 
Sex: Female, Male 
[Units: Participants]
Count of Participants
       
Female      54  48.6%      48  42.9%      2  66.7%      104  46.0% 
Male      57  51.4%      64  57.1%      1  33.3%      122  54.0% 
Ethnicity (NIH/OMB) 
[Units: Participants]
Count of Participants
       
Hispanic or Latino      25  22.5%      29  25.9%      1  33.3%      55  24.3% 
Not Hispanic or Latino      82  73.9%      79  70.5%      2  66.7%      163  72.1% 
Unknown or Not Reported      4   3.6%      4   3.6%      0   0.0%      8   3.5% 
Race (NIH/OMB) 
[Units: Participants]
Count of Participants
       
American Indian or Alaska Native      0   0.0%      1   0.9%      0   0.0%      1   0.4% 
Asian      2   1.8%      4   3.6%      0   0.0%      6   2.7% 
Native Hawaiian or Other Pacific Islander      0   0.0%      0   0.0%      0   0.0%      0   0.0% 
Black or African American      12  10.8%      11   9.8%      0   0.0%      23  10.2% 
White      87  78.4%      82  73.2%      3 100.0%      172  76.1% 
More than one race      0   0.0%      0   0.0%      0   0.0%      0   0.0% 
Unknown or Not Reported      10   9.0%      14  12.5%      0   0.0%      24  10.6% 
Region of Enrollment 
[Units: Participants]
Count of Participants
       
Canada   5   4   0   9 
United States   105   102   3   210 
Australia   1   5   0   6 
Puerto Rico   0   1   0   1 


  Outcome Measures
  Show All Outcome Measures

1.  Primary:   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. ]

2.  Secondary:   Incidence of Severe Oral Mucositis   [ Time Frame: Day -1 (day prior to stem cell infusion) to Day 20 following transplantation. ]

3.  Secondary:   Oral Mucositis Daily Questionnaire (OMDQ)   [ Time Frame: Day -1 (day prior to stem cell infusion) to Day 20 following transplantation ]

4.  Secondary:   Incidence of Parenteral Opioid Analgesic Use (Morphine Equivalents).   [ Time Frame: Day -1 (day prior to stem cell infusion) to Day 20 following transplantation. ]

5.  Secondary:   Duration of Parenteral Opioid Analgesic Use (Morphine Equivalents).   [ Time Frame: Day -1 (day prior to stem cell infusion) to Day 20 following transplantation. ]

6.  Secondary:   Total Dose of Parenteral Opioid Analgesic Used (Morphine Equivalents).   [ Time Frame: Day -1 (day prior to stem cell infusion) to Day 20 following transplantation. ]

7.  Secondary:   Incidence of Total Parenteral Nutrition (TPN) Administration.   [ Time Frame: Day -1 (day prior to stem cell infusion) to Day 20 following transplantation. ]

8.  Secondary:   Duration of Total Parenteral Nutrition (TPN) Administration.   [ Time Frame: Day -1 (day prior to stem cell infusion) to Day 20 following transplantation. ]

9.  Secondary:   Incidence of Febrile Neutropenia   [ Time Frame: Day -1 (day prior to stem cell infusion) to Day 20 following transplantation. ]

10.  Secondary:   Incidence of Invasive Bacterial Infections   [ Time Frame: Day -1 (day prior to stem cell infusion) to Day 20 following transplantation. ]

11.  Secondary:   Severity of Mucositis   [ Time Frame: Day -1 (day prior to stem cell infusion) to Day 20 following transplantation ]

12.  Other Pre-specified:   Ancillary Validation Study of ChIMES   [ Time Frame: Day -1 (day prior to stem cell infusion) to Day 20 following transplantation. ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
  Hide Limitations and Caveats

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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  More Information
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Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
The agreement is:
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.


Results Point of Contact:  
Name/Title: Results Reporting Coordinator
Organization: Children's Oncology Group
phone: 626-447-0064
e-mail: resultsreporingcoordinator@childrensoncologygroup.org


Publications:

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 Submitted: February 25, 2011
First Posted: February 28, 2011
Results First Submitted: November 30, 2016
Results First Posted: May 9, 2017
Last Update Posted: May 9, 2017