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Ice Chips or Saline Mouth Rinse in Reducing or Preventing Mucositis in Patients Receiving Melphalan and Autologous Stem Cell Transplant for Multiple Myeloma
This study has been completed.
Sponsored by: Fred Hutchinson Cancer Research Center
Information provided by: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT00118339
  Purpose

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 Intervention Phase
Cancer-Related Problem/Condition
Multiple Myeloma and Plasma Cell Neoplasm
Procedure: chemoprotection
Procedure: complementary or alternative medicine procedure
Procedure: management of therapy complications
Phase III

Genetics Home Reference related topics: aceruloplasminemia hemophilia
MedlinePlus related topics: Cancer Multiple Myeloma
Drug Information available for: Melphalan Melphalan hydrochloride Sarcolysin
U.S. FDA Resources
Study Type: Interventional
Study Design: Supportive Care, Randomized, Active Control
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

Further study details as provided by National Cancer Institute (NCI):

Study Start Date: July 2003
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 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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

DISEASE CHARACTERISTICS:

  • Diagnosis of multiple myeloma
  • Scheduled to undergo an autologous peripheral blood stem cell transplantation (PBSCT) for multiple myeloma on protocol FHCRC-1137.00

    • Scheduled to receive a regimen of single-agent melphalan at a dose of 200 mg/m^2 before PBSCT

PATIENT CHARACTERISTICS:

Age

  • Over 18

Performance status

  • Not specified

Life expectancy

  • Not specified

Hematopoietic

  • Not specified

Hepatic

  • Not specified

Renal

  • Not specified

PRIOR CONCURRENT THERAPY:

Biologic therapy

  • See Disease Characteristics

Chemotherapy

  • See Disease Characteristics

Endocrine therapy

  • Not specified

Radiotherapy

  • Not specified

Surgery

  • Not specified

Other

  • No concurrent artificial saliva on the day of melphalan infusion (day -2)
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00118339

Locations
United States, Washington
Fred Hutchinson Cancer Research Center
Seattle, Washington, United States, 98109-1024
Sponsors and Collaborators
Fred Hutchinson Cancer Research Center
Investigators
Principal Investigator: William I. Bensinger, MD Fred Hutchinson Cancer Research Center
  More Information

Clinical trial summary from the National Cancer Institute's PDQ® database  This link exits the ClinicalTrials.gov site

Study ID Numbers: CDR0000430699, FHCRC-1845.00
Study First Received: July 8, 2005
Last Updated: October 18, 2008
ClinicalTrials.gov Identifier: NCT00118339  
Health Authority: United States: Federal Government

Keywords provided by National Cancer Institute (NCI):
oral complications
drug/agent toxicity by tissue/organ
stage I multiple myeloma
stage II multiple myeloma
stage III multiple myeloma

Study placed in the following topic categories:
Melphalan
Immunoproliferative Disorders
Mucositis
Blood Protein Disorders
Hematologic Diseases
Blood Coagulation Disorders
Vascular Diseases
Paraproteinemias
Hemostatic Disorders
Multiple Myeloma
Hemorrhagic Disorders
Multiple myeloma
Lymphoproliferative Disorders
Neoplasms, Plasma Cell

Additional relevant MeSH terms:
Neoplasms
Neoplasms by Histologic Type
Immune System Diseases
Cardiovascular Diseases

ClinicalTrials.gov processed this record on January 16, 2009