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.
Verified April 2013 by The University of Texas Health Science Center at San Antonio
Sponsor:
The University of Texas Health Science Center at San Antonio
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
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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
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 | 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 |
ClinicalTrials.gov processed this record on May 23, 2013