Ice Chips or Saline Mouth Rinse in Reducing or Preventing Mucositis in Patients Receiving Melphalan and Autologous Stem Cell Transplant for Multiple Myeloma
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|ClinicalTrials.gov Identifier: NCT00118339|
Recruitment Status : Completed
First Posted : July 11, 2005
Last Update Posted : September 1, 2011
RATIONALE: Chemoprotective agents may protect normal cells from the side effects of chemotherapy. Ice chips or saline mouth rinse may lessen the severity or help prevent symptoms of mucositis or mouth sores in patients receiving melphalan and autologous stem cell transplant for multiple myeloma. It is not yet known whether ice chips are more effective than saline mouth rinse in reducing or preventing mucositis.
PURPOSE: This randomized phase III trial is studying ice chips to see how well they work compared to saline mouth rinse in reducing or preventing mucositis in patients receiving melphalan and autologous stem cell transplant for multiple myeloma.
|Condition or disease||Intervention/treatment|
|Multiple Myeloma Plasma Cell Neoplasm||Drug: chemoprotection Procedure: complementary or alternative medicine procedure Procedure: management of therapy complications|
- Compare the efficacy of administering ice chips vs room temperature normal saline oral rinse before, during, and after melphalan administration, in terms of reducing or eliminating grade 3 or 4 oral mucositis, in patients undergoing autologous peripheral blood stem cell transplantation (PBSCT) for multiple myeloma.
- Compare the number of days that IV narcotic therapy is required for oral mucositis pain in patients treated with these regimens.
- Compare the use of IV hydration and/or total parenteral nutrition after autologous PBSCT in patients treated with these regimens.
- Compare overall quality of life, in terms of ability to eat food and drink liquids, in patients treated with these regimens.
OUTLINE: This is a randomized, pilot study. Patients are stratified according to age (less than 60 years vs 60 years and over). Patients are randomized to 1 of 2 treatment arms.
- Arm I: Patients receive oral ice chips 15 minutes before, during, and for 8 hours after melphalan infusion* on day -2.
- Arm II: Patients receive room temperature normal saline oral rinses over 30 seconds 15 minutes before, during, and for 8 hours after melphalan infusion* on day -2.
All patients undergo autologous peripheral blood stem cell transplantation (PBSCT)* on day 0.
NOTE: *Patients receive melphalan infusion and undergo autologous PBSCT on protocol FHCRC-1137.00.
Quality of life is assessed 3 days a week for 4 weeks.
After completion of study treatment, patients are followed for 28 days and then periodically thereafter.
PROJECTED ACCRUAL: A total of 40 patients (20 per treatment arm) will be accrued for this study within 18 months.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||41 participants|
|Primary Purpose:||Supportive Care|
|Official Title:||A Prospective Randomized Pilot Study Using Ice Chips Versus Room Temperature Normal Saline Rinses Orally During Administration of Melphalan to Decrease the Severity and Duration of Oral Mucositis in Patients With Multiple Myeloma Undergoing Autologous Peripheral Blood Stem Cell Transplant|
|Study Start Date :||July 2003|
|Primary Completion Date :||May 2006|
|Study Completion Date :||May 2006|
U.S. FDA Resources
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00118339
|United States, Washington|
|Fred Hutchinson Cancer Research Center|
|Seattle, Washington, United States, 98109-1024|
|Principal Investigator:||William I. Bensinger, MD||Fred Hutchinson Cancer Research Center|