CompletedPhase 3

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

United States, Australia, Canada226 participantsStarted 2011-03

Plain-language 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.

Who can participate

Age range

4 Years – 21 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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 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

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Duration of Severe Oral Mucositis (WHO Grade 3 or 4)

Timeframe: Day -1 (day prior to stem cell infusion) to Day 20 following transplantation.

Trial details

NCT IDNCT01305200

SponsorChildren's Oncology Group

Sponsor typeNETWORK

Study typeINTERVENTIONAL

Primary completion2015-06

Results submitted2016-11-30

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