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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


N/A
18 Years
N/A
Not Enrolling
Both
Multiple Myeloma, Plasma Cell Neoplasm

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Trial Information

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


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.

Inclusion 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)

Type of Study:

Interventional

Study Design:

Primary Purpose: Supportive Care

Principal Investigator

William I. Bensinger, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Fred Hutchinson Cancer Research Center

Authority:

United States: Federal Government

Study ID:

1845.00

NCT ID:

NCT00118339

Start Date:

July 2003

Completion Date:

May 2006

Related Keywords:

  • Multiple Myeloma
  • Plasma Cell Neoplasm
  • oral complications
  • drug/agent toxicity by tissue/organ
  • stage I multiple myeloma
  • stage II multiple myeloma
  • stage III multiple myeloma
  • Neoplasms
  • Multiple Myeloma
  • Neoplasms, Plasma Cell
  • Plasmacytoma
  • Mucositis

Name

Location

Fred Hutchinson Cancer Research CenterSeattle, Washington  98109