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Sponsored by: |
Fred Hutchinson Cancer Research Center |
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Information provided by: | National Cancer Institute (NCI) |
ClinicalTrials.gov Identifier: | NCT00118339 |
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 |
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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 |
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 |
Study Start Date: | July 2003 |
OBJECTIVES:
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.
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.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Scheduled to undergo an autologous peripheral blood stem cell transplantation (PBSCT) for multiple myeloma on protocol FHCRC-1137.00
PATIENT CHARACTERISTICS:
Age
Performance status
Life expectancy
Hematopoietic
Hepatic
Renal
PRIOR CONCURRENT THERAPY:
Biologic therapy
Chemotherapy
Endocrine therapy
Radiotherapy
Surgery
Other
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 |
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 |
oral complications drug/agent toxicity by tissue/organ stage I multiple myeloma stage II multiple myeloma stage III multiple myeloma |
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 |
Neoplasms Neoplasms by Histologic Type Immune System Diseases Cardiovascular Diseases |