Trial Review

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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
Trial website
Trial related presentations / publications
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

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.

Results are available at https://clinicaltrials.gov/study/NCT01305200