Ice Chips or Saline Mouth Rinse in Reducing or Preventing Mucositis in Patients Receiving Melphalan and Autologous Stem Cell Transplant for Multiple Myeloma

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.

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)