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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01305200
Other study ID # ACCL1031
Secondary ID NCI-2011-02635CD
Status Completed
Phase Phase 3
First received
Last updated
Start date March 2011
Est. completion date June 30, 2015

Study information

Verified date November 2016
Source Children's Oncology Group
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Description:

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Study Design


Related Conditions & MeSH terms

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Intervention

Drug:
supersaturated calcium phosphate rinse
Mouth rinse
Other:
placebo
Mouth rinse
questionnaire administration
Ancillary studies
Procedure:
quality-of-life assessment
Ancillary studies

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Sponsors (2)

Lead Sponsor Collaborator
Children's Oncology Group National Cancer Institute (NCI)

Countries where clinical trial is conducted

United States,  Australia,  Canada, 

References & 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. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Other Ancillary Validation Study of ChIMES Day -1 (day prior to stem cell infusion) to Day 20 following transplantation.
Primary 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 Incidence of Severe Oral Mucositis Percentage of patients with Severe Oral Mucositis (WHO Grade 3 or 4) per arm. Day -1 (day prior to stem cell infusion) to Day 20 following transplantation.
Secondary Oral Mucositis Daily Questionnaire (OMDQ) Area under the curve (AUC) of the Oral Mucositis Daily Questionnaire (OMDQ) subscales Day -1 (day prior to stem cell infusion) to Day 20 following transplantation
Secondary Incidence of Parenteral Opioid Analgesic Use (Morphine Equivalents). Opioid Administration = yes Day -1 (day prior to stem cell infusion) to Day 20 following transplantation.
Secondary Duration of Parenteral Opioid Analgesic Use (Morphine Equivalents). Mean days of parenteral opioid analgesic use. Day -1 (day prior to stem cell infusion) to Day 20 following transplantation.
Secondary Total Dose of Parenteral Opioid Analgesic Used (Morphine Equivalents). Morphine equivalent dose in mg/kg/day Day -1 (day prior to stem cell infusion) to Day 20 following transplantation.
Secondary Incidence of Total Parenteral Nutrition (TPN) Administration. Total Parenteral Nutrition = yes Day -1 (day prior to stem cell infusion) to Day 20 following transplantation.
Secondary Duration of Total Parenteral Nutrition (TPN) Administration. Mean days of total parenteral nutrition (TPN) administration. Day -1 (day prior to stem cell infusion) to Day 20 following transplantation.
Secondary Incidence of Febrile Neutropenia Fever and Neutropenia = yes Day -1 (day prior to stem cell infusion) to Day 20 following transplantation.
Secondary Incidence of Invasive Bacterial Infections Invasive Bacterial Infection = yes Day -1 (day prior to stem cell infusion) to Day 20 following transplantation.
Secondary Severity of Mucositis 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. Day -1 (day prior to stem cell infusion) to Day 20 following transplantation
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