Ignite Creation Date:
2024-05-05 @ 11:42 AM
Last Modification Date:
2024-10-26 @ 9:12 AM
Study NCT ID:
NCT00118339
Status:
COMPLETED
Last Update Posted:
2011-09-01
First Post:
2005-07-08
Brief Title:
Ice Chips or Saline Mouth Rinse in Reducing or Preventing Mucositis in Patients Receiving Melphalan and Autologous Stem Cell Transplant for Multiple Myeloma
Sponsor:
Fred Hutchinson Cancer Center
Organization:
Fred Hutchinson Cancer Center
Study Overview
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
Status:
COMPLETED
Status Verified Date:
2011-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
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
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
Detailed Description:
OBJECTIVES
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 andor 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-113700
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
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 andor 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-113700
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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| CDR0000430699 | REGISTRY | PDQ | None |
| FHCRC-184500 | None | None | None |