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 has been completed.
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: July 16, 2015
Last verified: July 2015
Results First Received: June 4, 2015  
Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Open Label;   Primary Purpose: Prevention
Conditions: Mucositis
Multiple Myeloma
Interventions: Drug: 0.9% Sodium Chloride irrigation solution
Other: Cryotherapy (ice chips)
Device: Calcium phosphate (Caphosol) Ca2+/PO43- mouth rinse

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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Reporting Groups
  Description
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.

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

Cryotherapy (Ice Chips) 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.
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.

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.


Participant Flow:   Overall Study
    0.9% Sodium Chloride Irrigation Solution     Cryotherapy (Ice Chips)     Calcium Phosphate (Caphosol) Mouth Rinse  
STARTED     38     40     39  
COMPLETED     38     40     39  
NOT COMPLETED     0     0     0  



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
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.

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

Cryotherapy (Ice Chips) 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.
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.

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.

Total Total of all reporting groups

Baseline Measures
    0.9% Sodium Chloride Irrigation Solution     Cryotherapy (Ice Chips)     Calcium Phosphate (Caphosol) Mouth Rinse     Total  
Number of Participants  
[units: participants]
  38     40     39     117  
Age  
[units: participants]
       
<=18 years     0     0     0     0  
Between 18 and 65 years     30     28     30     88  
>=65 years     8     12     9     29  
Age  
[units: years]
Mean (Full Range)
  61.5  
  (43 to 70)  
  62  
  (39 to 75)  
  62  
  (45 to 68)  
  62  
  (39 to 75)  
Gender  
[units: participants]
       
Female     2     2     3     7  
Male     36     38     36     110  
Ethnicity (NIH/OMB)  
[units: participants]
       
Hispanic or Latino     7     9     5     21  
Not Hispanic or Latino     31     31     34     96  
Unknown or Not Reported     0     0     0     0  
Race (NIH/OMB)  
[units: participants]
       
American Indian or Alaska Native     0     0     0     0  
Asian     0     0     0     0  
Native Hawaiian or Other Pacific Islander     0     0     0     0  
Black or African American     14     15     11     40  
White     24     25     28     77  
More than one race     0     0     0     0  
Unknown or Not Reported     0     0     0     0  
Region of Enrollment  
[units: participants]
       
United States     38     40     39     117  



  Outcome Measures

1.  Primary:   Incidence of Oral Mucositis   [ Time Frame: First 30 days post-tranplantation ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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  More Information
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Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.


Results Point of Contact:  
Name/Title: Juan J Toro
Organization: South Texas Veterans Health Care System
phone: 210-617-5300 ext 16777
e-mail: juan.toro2@va.gov



Responsible Party: Juan Toro, 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
Results First Received: June 4, 2015
Last Updated: July 16, 2015
Health Authority: United States: Institutional Review Board
United States: Federal Government