Randomized Trial of Cryotherapy Duration Prior to High Dose Melphalan in Myeloma Patients
| Status: | Recruiting |
|---|---|
| Conditions: | Blood Cancer, Blood Cancer, Blood Cancer, Blood Cancer, Hematology |
| Therapuetic Areas: | Hematology, Oncology |
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 5/5/2014 |
| Start Date: | April 2012 |
| Contact: | Ohio State Unversity Comprehensive Cancer Center |
| Email: | Jamesline@osumc.edu |
| Phone: | 1-800-293-5066 |
A Randomized Study to Compare the Effect of Short- and Long-Term Schedules of Cryotherapy on the Incidence and Severity of Mucositis in High-Dose Melphalan
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
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 OBJECTIVES:
I. To measure the maximum inpatient mucositis grade after 120- vs. 360-minutes standardized
cryotherapy regimens in patients with multiple myeloma undergoing autologous hematopoietic
stem cell transplantation at Ohio State Medical Center.
SECONDARY OBJECTIVES:
I. To develop a pharmacokinetic model predicting variability in unbound serum melphalan area
under the concentration-time curve (AUC).
II. To compare the neutropenic fever and bacteremia incidence after 120- vs. 360-minute
cryotherapy regimens.
III. To compare patient-reported mucositis-related symptoms up until discharge utilizing the
Patient-Reported Oral Mucositis Symptoms Scale (PROMS) after 120- vs 360-minute cryotherapy
regimens.
OUTLINE: Patients are randomized to 1 of 2 treatment arms.
ARM I: Beginning fifteen minutes before melphalan treatment, patients receive 1 ounce of
shaved ice in their mouth, allow it to melt and then replenish it immediately for 120
minutes.
ARM II: Beginning fifteen minutes before melphalan treatment, patients receive 1 ounce of
shaved ice in their mouth, allow it to melt and then replenish it immediately for 360
minutes.
I. To measure the maximum inpatient mucositis grade after 120- vs. 360-minutes standardized
cryotherapy regimens in patients with multiple myeloma undergoing autologous hematopoietic
stem cell transplantation at Ohio State Medical Center.
SECONDARY OBJECTIVES:
I. To develop a pharmacokinetic model predicting variability in unbound serum melphalan area
under the concentration-time curve (AUC).
II. To compare the neutropenic fever and bacteremia incidence after 120- vs. 360-minute
cryotherapy regimens.
III. To compare patient-reported mucositis-related symptoms up until discharge utilizing the
Patient-Reported Oral Mucositis Symptoms Scale (PROMS) after 120- vs 360-minute cryotherapy
regimens.
OUTLINE: Patients are randomized to 1 of 2 treatment arms.
ARM I: Beginning fifteen minutes before melphalan treatment, patients receive 1 ounce of
shaved ice in their mouth, allow it to melt and then replenish it immediately for 120
minutes.
ARM II: Beginning fifteen minutes before melphalan treatment, patients receive 1 ounce of
shaved ice in their mouth, allow it to melt and then replenish it immediately for 360
minutes.
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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
We found this trial at
1
site
The Ohio State University, Wexner Medical Center Located in Columbus, The Ohio State University Wexner...
Click here to add this to my saved trials
