Comparative Trial of Cryotherapy Versus Caphosol Versus Saline Solution Mouth Washes for the Prevention of Oral Mucositis in Patients With Multiple Myeloma Undergoing Hematopoietic Stem Cell Transplantation

NCT01066624 | Completed Results

• 1 other identifier: HSC20090454H
• Study Type: interventional
• Target: 117
• Locations: 1 country
• Sites: 1

Brief Summary

Chemotherapy-induced oral mucositis is the inflammation of the oral mucous membranes, which are tissues that line the mouth. Oral mucositis is caused when chemotherapy attacks and kills the rapidly-dividing cells in the oral mucous membranes. This condition feels like sunburn (or heartburn) on the mucous tissues, and often leads to sores in the mouth or on the tongue. This can cause discomfort, pain, difficulties in eating, and a longer hospital stay. Several therapies appear to either prevent or reduce the severity of mouth ulcers caused by chemotherapy for multiple myeloma. Different strategies are used to try and prevent this condition; a small number of trials found that some of these strategies may be effective. None of the trials had compared head to head the use of saline solution (our standard of care), cryotherapy (ice chips) and Caphosol in patients receiving high-dose melphalan. The goal of this research study to evaluate the effectiveness of saline solution, cryotherapy, Caphosol for the prevention of oral mucositis in patients with multiple myeloma receiving high-dose chemotherapy followed by autologous hematopoietic stem cell transplantation. The researchers hope to learn if there are any differences among saline solution, cryotherapy and Caphosol mouth rinse for the prevention of oral mucositis.

Conditions

Mucositis; Multiple Myeloma

Keywords

Mucositis; Multiple myeloma; Autologous hematopoietic stem cell transplantation

Outcome Measures

Primary Outcomes (1)

• Incidence of Oral Mucositis

  Incidence of grade I-IV oral mucositis

  First 30 days post-tranplantation

Study Arms (3)

0.9% Sodium Chloride irrigation solution

ACTIVE COMPARATOR

Standard of care for prevention and management of oral mucositis (0.9% Sodium Chloride irrigation solution): Patients randomized to this group will be instructed to rinse their mouths twice, with 1 ounce (30 ml) of room temperature 0.9% NaCl (normal saline), 4 times daily after admission and until end of study.

Drug: 0.9% Sodium Chloride irrigation solution

Cryotherapy (ice chips)

ACTIVE COMPARATOR

Patients randomized to this group, on day -2 and -1, will be instructed to place approximately 1 ounce of crushed ice in their mouths 15 minutes prior to the initiation of melphalan infusion. The ice will be allowed to melt and should be replenish as soon as it had completely melted. Patients will be instructed to continue this procedure during the melphalan infusion and for 90 minutes after the end of the infusion. After patients are done with the cryotherapy they will follow the standard of care for prevention and management of oral mucositis until the end of the study.

Other: Cryotherapy (ice chips)

Calcium phosphate (Caphosol) mouth rinse

ACTIVE COMPARATOR

Patients randomized to this group will be instructed to rinse their mouths with Caphosol 4 times daily after admission and until end of study.

Device: Calcium phosphate (Caphosol) Ca2+/PO43- mouth rinse

Interventions

0.9% Sodium Chloride irrigation solution DRUG

Patients randomized to this group will be instructed to rinse their mouths twice, with 1 ounce (30 ml) of room temperature 0.9% NaCl (normal saline), 4 times daily after admission and until end of study

Also known as: Normal Saline Solution

0.9% Sodium Chloride irrigation solution

Cryotherapy (ice chips) OTHER

Patients randomized to this group, on day -2 and -1, will be instructed to place approximately 1 ounce of crushed ice in their mouths 15 minutes prior to the initiation of melphalan infusion. The ice will be allowed to melt and should be replenish as soon as it had completely melted. Patients will be instructed to continue this procedure during the melphalan infusion and for 90 minutes after the end of the infusion.

Cryotherapy (ice chips)

Calcium phosphate (Caphosol) Ca2+/PO43- mouth rinse DEVICE

Patients randomized to this group will be instructed to rinse their mouths with Caphosol 4 times daily after admission and until end of study.

Calcium phosphate (Caphosol) mouth rinse

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients must meet the following criteria to participate in this study:
• Age 18 years or older
• Patients with diagnosis of MM schedule to receive high-dose melphalan, as a single agent ,for conditioning regimen
• Signed Informed Consent Form

You may not qualify if:

• Patients will be excluded from the study for any of the following reasons:
• Patients who have taken palifermin (Kepivance) in the past 90 days
• Patients who have taken any investigational drug in the past 60 days
• Patient who have received radiation therapy in the past 60 days
• Serum creatinine greater than 2 mg/dL
• Patients with mucositis at the time of randomization
• Patients with altered mental status precluding understanding of the informed consent process an/or completion of the necessary assessments

Sponsors & Collaborators

• The University of Texas Health Science Center at San Antonio: lead
• South Texas Veterans Health Care System: collaborator

Study Sites (1)

South Texas Veterans Health Care System

San Antonio, Texas, 78229, United States

Location

MeSH Terms

Conditions

Mucositis; Multiple Myeloma

Interventions

Saline Solution; Cryotherapy

Condition Hierarchy (Ancestors)

Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Mouth Diseases; Stomatognathic Diseases; Neoplasms, Plasma Cell; Neoplasms by Histologic Type; Neoplasms; Hemostatic Disorders; Vascular Diseases; Cardiovascular Diseases; Paraproteinemias; Blood Protein Disorders; Hematologic Diseases; Hemic and Lymphatic Diseases; Hemorrhagic Disorders; Lymphoproliferative Disorders; Immunoproliferative Disorders; Immune System Diseases

Intervention Hierarchy (Ancestors)

Crystalloid Solutions; Isotonic Solutions; Solutions; Pharmaceutical Preparations; Therapeutics

Results Point of Contact

• Title: Juan J Toro
• Organization: South Texas Veterans Health Care System

juan.toro2@va.gov

210-617-5300

Study Officials

• Cesar O Freytes, MD

  The University of Texas Health Science Center at San Antonio

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Research Fellow, Health Science Specialist

Study Record Dates

• First Submitted: February 8, 2010
• First Posted: February 10, 2010
• Study Start: August 1, 2009
• Primary Completion: January 1, 2014
• Study Completion: January 1, 2014
• Last Updated: July 23, 2015
• Results First Posted: July 23, 2015

Record last verified: 2015-07

Locations

US (1)