Randomized Trial of Cryotherapy Duration Prior to High Dose Melphalan in Myeloma Patients

Completed · Not applicable

Conditions studied: Refractory Multiple Myeloma, Stage I Multiple Myeloma, Stage II Multiple Myeloma, Stage III Multiple Myeloma

In brief

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

Key facts

Study ID: NCT01653106
Run by: Ohio State University Comprehensive Cancer Center
People needed: 148
Starts: 2012-04-01
Expected to finish: 2015-03-01
Last updated by the study team: 2017-06-27

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

Patients must be diagnosed with multiple myeloma be admitted for autologous stem cell transplantation
Age > 18 years
Patients or their legal representatives must be able to read, understand and provide informed consent to participate in the trial

You may not qualify if…

Any other medical condition, including mental illness or substance abuse, deemed by the principal investigator to likely interfere with a patient's ability to sign informed consent, cooperate and participate in the study, or interfere with the interpretation of the results

Where it is running

Ohio State University Medical Center — Columbus, Ohio, United States

Full record on ClinicalTrials.gov

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