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NCT01066624 · ClinicalTrials.gov registry record · NA
Comparative Trial of Cryotherapy Versus Caphosol Versus Saline Solution Mouth Washes for the Prevention of Oral Mucositis in Patients With Multiple Myeloma Undergoing Hematopoietic Stem Cell Transplantation
A NA study, sponsored by The University of Texas Health Science Center at San Antonio.
- Completed
- Registry status
- NA
- Development phase
- 117
- Enrollment target
NCT01066624: Completed NA study, sponsored by The University of Texas Health Science Center at San Antonio.
NCT01066624 is a NA study that has completed, run by The University of Texas Health Science Center at San Antonio. The registered enrollment target is 117 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (92% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01066624, a NA study, has completed, sponsored by The University of Texas Health Science Center at San Antonio.
- COMPLETED
- Registry status
- NA
- Development phase
- 117 participants
- Enrollment target
Study Summary
Chemotherapy-induced oral mucositis is the inflammation of the oral mucous membranes, which are tissues that line the mouth. Oral mucositis is caused when chemotherapy attacks and kills the rapidly-dividing cells in the oral mucous membranes. This condition feels like sunburn (or heartburn) on the mucous tissues, and often leads to sores in the mouth or on the tongue. This can cause discomfort, pain, difficulties in eating, and a longer hospital stay. Several therapies appear to either prevent or reduce the severity of mouth ulcers caused by chemotherapy for multiple myeloma. Different strategies are used to try and prevent this condition; a small number of trials found that some of these strategies may be effective. None of the trials had compared head to head the use of saline solution (our standard of care), cryotherapy (ice chips) and Caphosol in patients receiving high-dose melphalan. The goal of this research study to evaluate the effectiveness of saline solution, cryotherapy, Caphosol for the prevention of oral mucositis in patients with multiple myeloma receiving high-dose chemotherapy followed by autologous hematopoietic stem cell transplantation. The researchers hope to learn if there are any differences among saline solution, cryotherapy and Caphosol mouth rinse for the prevention of oral mucositis.
Primary Outcome
Incidence of grade I-IV oral mucositis
Interventions
- DRUG 0.9% Sodium Chloride irrigation solution
- OTHER Cryotherapy (ice chips)
- DEVICE Calcium phosphate (Caphosol) Ca2+/PO43- mouth rinse
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 117 participants |
| Start Date | 2009-08 |
| Est. Completion | 2014-01 |
| Phase | NA |
What the finished NCT01066624 record still lists
NCT01066624 is an interventional study that assigns participants to a tested intervention. The registered 117 participants enrollment target is mid-sized for trials with a published cap, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (92% lower).
The record links to 0 conditions, and to 3 interventions - of which 0.9% Sodium Chloride irrigation solution is the first listed.
NCT01066624 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01066624 about?
NCT01066624 is a clinical study titled "Comparative Trial of Cryotherapy Versus Caphosol Versus Saline Solution Mouth Washes for the Prevention of Oral Mucositis in Patients With Multiple Myeloma Undergoing Hematopoietic Stem Cell Transplantation". Chemotherapy-induced oral mucositis is the inflammation of the oral mucous membranes, which are tissues that line the mouth. Oral mucositis is caused when chemotherapy attacks and kills the rapidly-dividing cells in the oral mucous membranes. This condition feels like sunburn (or heartburn) on the m...
What is the current status of trial NCT01066624?
This trial is currently completed. It is a NA study. The enrollment target is 117 participants. The study started on 2009-08. Estimated completion is 2014-01.
What interventions are being tested in trial NCT01066624?
The interventions under investigation include: 0.9% Sodium Chloride irrigation solution (DRUG), Cryotherapy (ice chips) (OTHER), Calcium phosphate (Caphosol) Ca2+/PO43- mouth rinse (DEVICE).
Who is sponsoring clinical trial NCT01066624?
This trial is sponsored by The University of Texas Health Science Center at San Antonio, which has 378 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01066624's enrollment target sits among peer trials
117 807th of 2000 higher than 1,193 of 2,000 other NA trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other NA trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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