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.
Sponsor:
Information provided by:
Fred Hutchinson Cancer Research Center
ClinicalTrials.gov Identifier:
NCT00118339
First received: July 8, 2005
Last updated: August 30, 2011
Last verified: August 2011
  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
Multiple Myeloma
Plasma Cell Neoplasm
Drug: chemoprotection
Procedure: complementary or alternative medicine procedure
Procedure: management of therapy complications

Study Type: Interventional
Study Design: 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

Resource links provided by NLM:


Further study details as provided by Fred Hutchinson Cancer Research Center:

Enrollment: 41
Study Start Date: July 2003
Study Completion Date: May 2006
Primary Completion Date: May 2006 (Final data collection date for primary outcome measure)
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

Additional Information:
No publications provided

ClinicalTrials.gov Identifier: NCT00118339     History of Changes
Other Study ID Numbers: 1845.00, FHCRC-1845.00, CDR0000430699
Study First Received: July 8, 2005
Last Updated: August 30, 2011
Health Authority: United States: Federal Government

Keywords provided by Fred Hutchinson Cancer Research Center:
oral complications
drug/agent toxicity by tissue/organ
stage I multiple myeloma
stage II multiple myeloma
stage III multiple myeloma

Additional relevant MeSH terms:
Neoplasms
Multiple Myeloma
Neoplasms, Plasma Cell
Plasmacytoma
Mucositis
Neoplasms by Histologic Type
Hemostatic Disorders
Vascular Diseases
Cardiovascular Diseases
Paraproteinemias
Blood Protein Disorders
Hematologic Diseases
Hemorrhagic Disorders
Lymphoproliferative Disorders
Immunoproliferative Disorders
Immune System Diseases
Gastroenteritis
Gastrointestinal Diseases
Digestive System Diseases
Mouth Diseases
Stomatognathic Diseases
Melphalan
Myeloablative Agonists
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Pharmacologic Actions
Antineoplastic Agents
Therapeutic Uses
Antineoplastic Agents, Alkylating

ClinicalTrials.gov processed this record on April 21, 2014