NCT00118339

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
41

participants targeted

Target at P25-P50 for not_applicable multiple-myeloma

Timeline
Completed

Started Jul 2003

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2003

Completed
2 years until next milestone

First Submitted

Initial submission to the registry

July 8, 2005

Completed
3 days until next milestone

First Posted

Study publicly available on registry

July 11, 2005

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2006

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2006

Completed
Last Updated

September 1, 2011

Status Verified

August 1, 2011

Enrollment Period

2.8 years

First QC Date

July 8, 2005

Last Update Submit

August 30, 2011

Conditions

Multiple MyelomaPlasma Cell Neoplasm

Keywords

oral complicationsdrug/agent toxicity by tissue/organstage I multiple myelomastage II multiple myelomastage III multiple myeloma

Interventions

chemoprotectionDRUG
complementary or alternative medicine procedurePROCEDURE
management of therapy complicationsPROCEDURE

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
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)

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

Study Sites (1)

Fred Hutchinson Cancer Research Center

Seattle, Washington, 98109-1024, United States

Location

MeSH Terms

Conditions

Multiple MyelomaNeoplasms, Plasma CellDrug-Related Side Effects and Adverse Reactions

Condition Hierarchy (Ancestors)

Neoplasms by Histologic TypeNeoplasmsHemostatic DisordersVascular DiseasesCardiovascular DiseasesParaproteinemiasBlood Protein DisordersHematologic DiseasesHemic and Lymphatic DiseasesHemorrhagic DisordersLymphoproliferative DisordersImmunoproliferative DisordersImmune System DiseasesChemically-Induced Disorders

Study Officials

  • William I. Bensinger, MD

    Fred Hutchinson Cancer Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Purpose
SUPPORTIVE CARE
Sponsor Type
OTHER

Study Record Dates

First Submitted

July 8, 2005

First Posted

July 11, 2005

Study Start

July 1, 2003

Primary Completion

May 1, 2006

Study Completion

May 1, 2006

Last Updated

September 1, 2011

Record last verified: 2011-08

Locations

US(1)