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

This study is currently recruiting participants. (see Contacts and Locations)
Verified April 2013 by The University of Texas Health Science Center at San Antonio
Sponsor:
Collaborator:
South Texas Veterans Health Care System
Information provided by (Responsible Party):
Juan Toro, The University of Texas Health Science Center at San Antonio
ClinicalTrials.gov Identifier:
NCT01066624
First received: February 8, 2010
Last updated: April 2, 2013
Last verified: April 2013
  Purpose

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.


Condition Intervention
Mucositis
Multiple Myeloma
Drug: 0.9% Sodium Chloride irrigation solution
Other: Cryotherapy (ice chips)
Device: Calcium phosphate (Caphosol) Ca2+/PO43- mouth rinse

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: A Prospective, Randomized, 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.

Resource links provided by NLM:


Further study details as provided by The University of Texas Health Science Center at San Antonio:

Primary Outcome Measures:
  • Incidence of severe oral mucositis [ Time Frame: First 30 days post-tranplantation ] [ Designated as safety issue: No ]

Estimated Enrollment: 165
Study Start Date: August 2009
Estimated Study Completion Date: September 2015
Estimated Primary Completion Date: September 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: 0.9% Sodium Chloride irrigation solution
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
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
Other Name: Normal Saline Solution
Active Comparator: Cryotherapy (ice chips)
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)
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.
Active Comparator: Calcium phosphate (Caphosol) mouth rinse
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
Patients randomized to this group will be instructed to rinse their mouths with Caphosol 4 times daily after admission and until end of study.

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01066624

Contacts
Contact: Juan J Toro, MD, MSCI 210-617-5300 ext 16777 juan.toro2@va.gov

Locations
United States, Texas
South Texas Veterans Health Care System Recruiting
San Antonio, Texas, United States, 78229
Contact: Juan J Toro, MD, MSCI    210-617-5300 ext 16777    juan.toro2@va.gov   
Principal Investigator: Juan J Toro, MD         
Principal Investigator: Cesar O Freytes, MD         
Sponsors and Collaborators
The University of Texas Health Science Center at San Antonio
South Texas Veterans Health Care System
Investigators
Study Director: Cesar O Freytes, MD The University of Texas Health Science Center at San Antonio
  More Information

No publications provided

Responsible Party: Juan Toro, Research Fellow, Health Science Specialist, The University of Texas Health Science Center at San Antonio
ClinicalTrials.gov Identifier: NCT01066624     History of Changes
Other Study ID Numbers: HSC20090454H
Study First Received: February 8, 2010
Last Updated: April 2, 2013
Health Authority: United States: Institutional Review Board
United States: Federal Government

Keywords provided by The University of Texas Health Science Center at San Antonio:
Mucositis
Multiple myeloma
Autologous hematopoietic stem cell transplantation

Additional relevant MeSH terms:
Multiple Myeloma
Neoplasms, Plasma Cell
Stomatitis
Mucositis
Neoplasms by Histologic Type
Neoplasms
Hemostatic Disorders
Vascular Diseases
Cardiovascular Diseases
Paraproteinemias
Blood Protein Disorders
Hematologic Diseases
Hemorrhagic Disorders
Lymphoproliferative Disorders
Immunoproliferative Disorders
Immune System Diseases
Mouth Diseases
Stomatognathic Diseases
Gastroenteritis
Gastrointestinal Diseases
Digestive System Diseases
Pharmaceutical Solutions
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on September 11, 2014