Supersaturated Calcium Phosphate Rinse in Preventing Oral Mucositis in Young Patients Undergoing Autologous or Donor Stem Cell Transplant
A Randomized Double Blinded Trial of Topical Caphosol to Prevent Oral Mucositis in Children Undergoing Hematopoietic Stem Cell Transplantation
5 other identifiers
interventional
226
3 countries
35
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_3
Started Mar 2011
Typical duration for phase_3
35 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
February 25, 2011
CompletedFirst Posted
Study publicly available on registry
February 28, 2011
CompletedStudy Start
First participant enrolled
March 1, 2011
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2015
CompletedStudy Completion
Last participant's last visit for all outcomes
June 30, 2015
CompletedResults Posted
Study results publicly available
May 9, 2017
CompletedSeptember 17, 2019
November 1, 2016
4.3 years
February 25, 2011
November 30, 2016
September 9, 2019
Conditions
Outcome Measures
Primary Outcomes (1)
Duration of Severe Oral Mucositis (WHO Grade 3 or 4)
Mean days of severe (WHO Grade 3 or 4) Mucositis.
Day -1 (day prior to stem cell infusion) to Day 20 following transplantation.
Secondary Outcomes (10)
Incidence of Severe Oral Mucositis
Day -1 (day prior to stem cell infusion) to Day 20 following transplantation.
Oral Mucositis Daily Questionnaire (OMDQ)
Day -1 (day prior to stem cell infusion) to Day 20 following transplantation
Incidence of Parenteral Opioid Analgesic Use (Morphine Equivalents).
Day -1 (day prior to stem cell infusion) to Day 20 following transplantation.
Duration of Parenteral Opioid Analgesic Use (Morphine Equivalents).
Day -1 (day prior to stem cell infusion) to Day 20 following transplantation.
Total Dose of Parenteral Opioid Analgesic Used (Morphine Equivalents).
Day -1 (day prior to stem cell infusion) to Day 20 following transplantation.
- +5 more secondary outcomes
Other Outcomes (1)
Ancillary Validation Study of ChIMES
Day -1 (day prior to stem cell infusion) to Day 20 following transplantation.
Study Arms (2)
Arm I (placebo)
PLACEBO COMPARATORPatients 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.
Arm II (supersaturated calcium phosphate rinse)
EXPERIMENTALPatients 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.
Interventions
Mouth rinse
Ancillary studies
Ancillary studies
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Children's Oncology Grouplead
- National Cancer Institute (NCI)collaborator
Study Sites (35)
Children's Oncology Group
Arcadia, California, 91006-3776, United States
City of Hope
Duarte, California, 91010, United States
Children's Hospital and Research Center at Oakland
Oakland, California, 94609-1809, United States
Rady Children's Hospital - San Diego
San Diego, California, 92123, United States
University of California San Francisco Medical Center-Parnassus
San Francisco, California, 94143, United States
Alfred I duPont Hospital for Children
Wilmington, Delaware, 19803, United States
Children's National Medical Center
Washington D.C., District of Columbia, 20010, United States
Miami Children's Hospital
Miami, Florida, 33155, United States
All Children's Hospital
St. Petersburg, Florida, 33701, United States
Children's Healthcare of Atlanta - Egleston
Atlanta, Georgia, 30322, United States
Lurie Children's Hospital-Chicago
Chicago, Illinois, 60614, United States
University of Chicago
Chicago, Illinois, 60637, United States
Riley Hospital for Children
Indianapolis, Indiana, 46202, United States
Kosair Children's Hospital
Louisville, Kentucky, 40202, United States
Children's Hospital-Main Campus
New Orleans, Louisiana, 70118, United States
Floating Hospital for Children at Tufts Medical Center
Boston, Massachusetts, 02111, United States
Dana-Farber Cancer Institute
Boston, Massachusetts, 02115, United States
C S Mott Children's Hospital
Ann Arbor, Michigan, 48109, United States
Mayo Clinic
Rochester, Minnesota, 55905, United States
University of Mississippi Medical Center
Jackson, Mississippi, 39216, United States
The Childrens Mercy Hospital
Kansas City, Missouri, 64108, United States
University of Nebraska Medical Center
Omaha, Nebraska, 68198, United States
Columbia University Medical Center
New York, New York, 10032, United States
Montefiore Medical Center
The Bronx, New York, 10467-2490, United States
Ny Cancer%
Valhalla, New York, 10595, United States
Nationwide Children's Hospital
Columbus, Ohio, 43205, United States
University of Oklahoma Health Sciences Center
Oklahoma City, Oklahoma, 73104, United States
Children's Hospital of Philadelphia
Philadelphia, Pennsylvania, 19104, United States
Children's Hospital of Pittsburgh of UPMC
Pittsburgh, Pennsylvania, 15224, United States
Methodist Children's Hospital of South Texas
San Antonio, Texas, 78229, United States
Midwest Children's Cancer Center
Milwaukee, Wisconsin, 53226, United States
Royal Childrens Hospital
Herston, Queensland, 4029, Australia
Princess Margaret Hospital for Children
Perth, Western Australia, 6008, Australia
Hospital for Sick Children
Toronto, Ontario, M5G 1X8, Canada
The Montreal Children's Hospital of the MUHC
Montreal, Quebec, H3H 1P3, Canada
Related Publications (1)
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: 27875526BACKGROUND
Related Links
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Results Reporting Coordinator
- Organization
- Children's Oncology Group
Study Officials
- PRINCIPAL INVESTIGATOR
Nathaniel Treister, MD
Children's Oncology Group
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, CARE PROVIDER
- Purpose
- SUPPORTIVE CARE
- Intervention Model
- PARALLEL
- Sponsor Type
- NETWORK
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
February 25, 2011
First Posted
February 28, 2011
Study Start
March 1, 2011
Primary Completion
June 1, 2015
Study Completion
June 30, 2015
Last Updated
September 17, 2019
Results First Posted
May 9, 2017
Record last verified: 2016-11