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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT01305200




Registration number
NCT01305200
Ethics application status
Date submitted
25/02/2011
Date registered
28/02/2011
Date last updated
17/09/2019

Titles & IDs
Public title
Supersaturated Calcium Phosphate Rinse in Preventing Oral Mucositis in Young Patients Undergoing Autologous or Donor Stem Cell Transplant
Scientific title
A Randomized Double Blinded Trial of Topical Caphosol to Prevent Oral Mucositis in Children Undergoing Hematopoietic Stem Cell Transplantation
Secondary ID [1] 0 0
NCI-2011-02635
Secondary ID [2] 0 0
ACCL1031
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Childhood Acute Lymphoblastic Leukemia in Remission 0 0
Childhood Acute Myeloid Leukemia in Remission 0 0
Childhood Chronic Myelogenous Leukemia 0 0
Childhood Myelodysplastic Syndromes 0 0
Chronic Eosinophilic Leukemia 0 0
Chronic Myelomonocytic Leukemia 0 0
Chronic Neutrophilic Leukemia 0 0
de Novo Myelodysplastic Syndromes 0 0
Disseminated Neuroblastoma 0 0
Juvenile Myelomonocytic Leukemia 0 0
Mucositis 0 0
Myelodysplastic/Myeloproliferative Neoplasm, Unclassifiable 0 0
Previously Treated Childhood Rhabdomyosarcoma 0 0
Previously Treated Myelodysplastic Syndromes 0 0
Recurrent Childhood Acute Lymphoblastic Leukemia 0 0
Recurrent Childhood Acute Myeloid Leukemia 0 0
Recurrent Childhood Large Cell Lymphoma 0 0
Recurrent Childhood Lymphoblastic Lymphoma 0 0
Recurrent Childhood Rhabdomyosarcoma 0 0
Recurrent Childhood Small Noncleaved Cell Lymphoma 0 0
Recurrent Malignant Testicular Germ Cell Tumor 0 0
Recurrent Wilms Tumor and Other Childhood Kidney Tumors 0 0
Recurrent/Refractory Childhood Hodgkin Lymphoma 0 0
Relapsing Chronic Myelogenous Leukemia 0 0
Secondary Acute Myeloid Leukemia 0 0
Secondary Myelodysplastic Syndromes 0 0
Unspecified Childhood Solid Tumor, Protocol Specific 0 0
Condition category
Condition code
Cancer 0 0 0 0
Lymphoma (non Hodgkin's lymphoma) - High grade lymphoma
Cancer 0 0 0 0
Lymphoma (non Hodgkin's lymphoma) - Low grade lymphoma
Cancer 0 0 0 0
Leukaemia - Acute leukaemia
Cancer 0 0 0 0
Leukaemia - Chronic leukaemia
Cancer 0 0 0 0
Children's - Leukaemia & Lymphoma
Blood 0 0 0 0
Haematological diseases
Cancer 0 0 0 0
Neuroendocrine tumour (NET)
Cancer 0 0 0 0
Children's - Other
Cancer 0 0 0 0
Sarcoma (also see 'Bone') - soft tissue
Cancer 0 0 0 0
Bone
Cancer 0 0 0 0
Kidney
Cancer 0 0 0 0
Testicular
Oral and Gastrointestinal 0 0 0 0
Other diseases of the mouth, teeth, oesophagus, digestive system including liver and colon
Blood 0 0 0 0
Other blood disorders
Other 0 0 0 0
Research that is not of generic health relevance and not applicable to specific health categories listed above

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - supersaturated calcium phosphate rinse
Other interventions - placebo
Other interventions - questionnaire administration
Treatment: Surgery - quality-of-life assessment

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.

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.


Treatment: Drugs: supersaturated calcium phosphate rinse
Mouth rinse

Other interventions: placebo
Mouth rinse

Other interventions: questionnaire administration
Ancillary studies

Treatment: Surgery: quality-of-life assessment
Ancillary studies
Intervention code [1] 0 0
Treatment: Drugs
Intervention code [2] 0 0
Other interventions
Intervention code [3] 0 0
Treatment: Surgery
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Duration of Severe Oral Mucositis (WHO Grade 3 or 4)
Timepoint [1] 0 0
Day -1 (day prior to stem cell infusion) to Day 20 following transplantation.
Secondary outcome [1] 0 0
Incidence of Severe Oral Mucositis
Timepoint [1] 0 0
Day -1 (day prior to stem cell infusion) to Day 20 following transplantation.
Secondary outcome [2] 0 0
Oral Mucositis Daily Questionnaire (OMDQ)
Timepoint [2] 0 0
Day -1 (day prior to stem cell infusion) to Day 20 following transplantation
Secondary outcome [3] 0 0
Incidence of Parenteral Opioid Analgesic Use (Morphine Equivalents).
Timepoint [3] 0 0
Day -1 (day prior to stem cell infusion) to Day 20 following transplantation.
Secondary outcome [4] 0 0
Duration of Parenteral Opioid Analgesic Use (Morphine Equivalents).
Timepoint [4] 0 0
Day -1 (day prior to stem cell infusion) to Day 20 following transplantation.
Secondary outcome [5] 0 0
Total Dose of Parenteral Opioid Analgesic Used (Morphine Equivalents).
Timepoint [5] 0 0
Day -1 (day prior to stem cell infusion) to Day 20 following transplantation.
Secondary outcome [6] 0 0
Incidence of Total Parenteral Nutrition (TPN) Administration.
Timepoint [6] 0 0
Day -1 (day prior to stem cell infusion) to Day 20 following transplantation.
Secondary outcome [7] 0 0
Duration of Total Parenteral Nutrition (TPN) Administration.
Timepoint [7] 0 0
Day -1 (day prior to stem cell infusion) to Day 20 following transplantation.
Secondary outcome [8] 0 0
Incidence of Febrile Neutropenia
Timepoint [8] 0 0
Day -1 (day prior to stem cell infusion) to Day 20 following transplantation.
Secondary outcome [9] 0 0
Incidence of Invasive Bacterial Infections
Timepoint [9] 0 0
Day -1 (day prior to stem cell infusion) to Day 20 following transplantation.
Secondary outcome [10] 0 0
Severity of Mucositis
Timepoint [10] 0 0
Day -1 (day prior to stem cell infusion) to Day 20 following transplantation

Eligibility
Key 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
Minimum age
4 Years
Maximum age
21 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key 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

Study design
Purpose of the study
Other
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s

Intervention assignment
Parallel
Other design features
Phase
Phase 3
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/03/2011
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
30/06/2015
Sample size
Target
Accrual to date
Final
226
Recruitment in Australia
Recruitment state(s)
QLD,WA
Recruitment hospital [1] 0 0
Royal Childrens Hospital - Herston
Recruitment hospital [2] 0 0
Princess Margaret Hospital for Children - Perth
Recruitment postcode(s) [1] 0 0
4029 - Herston
Recruitment postcode(s) [2] 0 0
6008 - Perth
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
California
Country [2] 0 0
United States of America
State/province [2] 0 0
Delaware
Country [3] 0 0
United States of America
State/province [3] 0 0
District of Columbia
Country [4] 0 0
United States of America
State/province [4] 0 0
Florida
Country [5] 0 0
United States of America
State/province [5] 0 0
Georgia
Country [6] 0 0
United States of America
State/province [6] 0 0
Illinois
Country [7] 0 0
United States of America
State/province [7] 0 0
Indiana
Country [8] 0 0
United States of America
State/province [8] 0 0
Kentucky
Country [9] 0 0
United States of America
State/province [9] 0 0
Louisiana
Country [10] 0 0
United States of America
State/province [10] 0 0
Massachusetts
Country [11] 0 0
United States of America
State/province [11] 0 0
Michigan
Country [12] 0 0
United States of America
State/province [12] 0 0
Minnesota
Country [13] 0 0
United States of America
State/province [13] 0 0
Mississippi
Country [14] 0 0
United States of America
State/province [14] 0 0
Missouri
Country [15] 0 0
United States of America
State/province [15] 0 0
Nebraska
Country [16] 0 0
United States of America
State/province [16] 0 0
New York
Country [17] 0 0
United States of America
State/province [17] 0 0
Ohio
Country [18] 0 0
United States of America
State/province [18] 0 0
Oklahoma
Country [19] 0 0
United States of America
State/province [19] 0 0
Pennsylvania
Country [20] 0 0
United States of America
State/province [20] 0 0
Texas
Country [21] 0 0
United States of America
State/province [21] 0 0
Wisconsin
Country [22] 0 0
Canada
State/province [22] 0 0
Ontario
Country [23] 0 0
Canada
State/province [23] 0 0
Quebec

Funding & Sponsors
Primary sponsor type
Other
Name
Children's Oncology Group
Address
Country
Other collaborator category [1] 0 0
Government body
Name [1] 0 0
National Cancer Institute (NCI)
Address [1] 0 0
Country [1] 0 0

Ethics approval
Ethics application status

Summary
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 website
https://clinicaltrials.gov/study/NCT01305200
Trial related presentations / publications
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.
Public notes

Contacts
Principal investigator
Name 0 0
Nathaniel Treister, MD
Address 0 0
Children's Oncology Group
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/study/NCT01305200