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NCT01653106 · ClinicalTrials.gov registry record · NA
Randomized Trial of Cryotherapy Duration Prior to High Dose Melphalan in Myeloma Patients
A NA study, sponsored by Ohio State University Comprehensive Cancer Center.
- Completed
- Registry status
- NA
- Development phase
- 148
- Enrollment target
NCT01653106: Completed NA study, sponsored by Ohio State University Comprehensive Cancer Center.
NCT01653106 is a NA study that has completed, run by Ohio State University Comprehensive Cancer Center. The registered enrollment target is 148 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (89% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01653106, a NA study, has completed, sponsored by Ohio State University Comprehensive Cancer Center.
- COMPLETED
- Registry status
- NA
- Development phase
- 148 participants
- Enrollment target
Study Summary
The purpose of this study is to compare the effect of short-term (2 hours/120 minutes) and long-term (6 hours/360 minutes) schedules of crushed ice therapy (cryotherapy). Patients that receive high dose melphalan for bone marrow transplantation commonly develop significant mouth pain and sores (oral mucositis) unless cryotherapy is utilized. The goal of this study is to scientifically determine (using randomization and a larger sample size) if a short-term schedule is as effective as the standard long-term schedule in preventing, or minimizing the symptoms involved with oral mucositis. The study is also trying to determine the best dose of melphalan and how patient's body breaks down melphalan and will obtain blood through central venous catheter to measure the amount of melphalan in patient's blood at specific times after the melphalan is infused
Primary Outcome
A Cochran-Mantel-Haenszel chi-square test will be used to compare the proportion of patients who develop severe mucositis between those treated with 120-minute vs. 360-minute cryotherapy. Logistic regression modeling will also be used with incidence of severe mucositis as the dependent variable and assess various factors in addition to treatment arm on this incidence.
Interventions
- OTHER questionnaire administration
- OTHER pharmacological study
- PROCEDURE cryotherapy
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 148 participants |
| Start Date | 2012-04 |
| Est. Completion | 2015-03 |
| Phase | NA |
What the finished NCT01653106 record still lists
NCT01653106 is an interventional study that assigns participants to a tested intervention. The registered 148 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 (89% lower).
The record links to 0 conditions, and to 3 interventions - of which questionnaire administration is the first listed.
NCT01653106 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01653106 about?
NCT01653106 is a clinical study titled "Randomized Trial of Cryotherapy Duration Prior to High Dose Melphalan in Myeloma Patients". The purpose of this study is to compare the effect of short-term (2 hours/120 minutes) and long-term (6 hours/360 minutes) schedules of crushed ice therapy (cryotherapy). Patients that receive high dose melphalan for bone marrow transplantation commonly develop significant mouth pain and sores (oral...
What is the current status of trial NCT01653106?
This trial is currently completed. It is a NA study. The enrollment target is 148 participants. The study started on 2012-04. Estimated completion is 2015-03.
What interventions are being tested in trial NCT01653106?
The interventions under investigation include: questionnaire administration (OTHER), pharmacological study (OTHER), cryotherapy (PROCEDURE).
Who is sponsoring clinical trial NCT01653106?
This trial is sponsored by Ohio State University Comprehensive Cancer Center, which has 341 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01653106's enrollment target sits among peer trials
148 702nd of 2000 higher than 1,298 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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