Cryotherapy in the Prevention of Chemotherapy-Induced Mucositis in Stem Cell Transplant
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|ClinicalTrials.gov Identifier: NCT02326675|
Recruitment Status : Terminated (Interim analysis: results of the analysis showed no significant difference between the two study groups)
First Posted : December 29, 2014
Last Update Posted : December 5, 2018
|Condition or disease||Intervention/treatment||Phase|
|Mucositis Hematopoietic Stem Cell Transplantation Peripheral Blood Stem Cell Transplantation Stomatitis||Other: Ice Other: Normal Saline Solution||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||29 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Primary Purpose:||Supportive Care|
|Official Title:||Randomized Controlled, Open-Label Study on the Use of Cryotherapy in the Prevention of Chemotherapy-Induced Mucositis in Stem Cell Transplant Patients|
|Actual Study Start Date :||March 2015|
|Actual Primary Completion Date :||December 2017|
|Actual Study Completion Date :||December 2017|
Active Comparator: Cryotherapy Group (Group A)
Subjects in the intervention group will receive both standard oral care and cryotherapy. During the 30 minute cryotherapy periods, subjects will eat ice chips, and/or consume very cold or frozen foods. Cryotherapy will begin 15 minutes prior to the start time of each etoposide infusion. After 30 minutes of cryotherapy, subjects will begin the saline rinses. The subject should perform 3 saline rinses over 15 minutes. After 15 minutes of saline rinses, the 30-minute cryotherapy / 15-minute saline rinse cycles will be repeated until 30 min after completion of etoposide infusion (approximately 150 minutes). In addition, an oral care diary will be completed by the subject, and a daily oral assessment will be performed by the investigators.
This group will receive cryotherapy, saline rinses, an oral care diary will be completed by the subject, and a daily oral assessment will be performed by the investigators as part of their participation.
Other Name: Cryotherapy,Ice Chips
Active Comparator: Standard Oral Care Group (Group B)
Subjects in the control group will receive standard oral care only. At the beginning of each etoposide infusion, the subject will begin the saline rinses. The subject will perform 3 saline rinses over 15 minutes followed by 30 minutes of rest (no rinses). The 15-minute saline rinse / 30-minute rest cycles will be repeated until 30 minutes after the completion of the etoposide infusion (approximately 150 minutes). In addition, an oral care diary will be completed by the subject, and a daily oral assessment will be performed by the investigators.
Other: Normal Saline Solution
This group will receive saline rinses, an oral care diary will be completed by the subject, and a daily oral assessment will be performed by the investigators as part of their participation.
- Number of participants that tolerate cryotherapy during each etoposide infusion [ Time Frame: Up to seven days prior to stem cell transplant. ]
- Time to onset, severity and duration of mucositis following etoposide administration [ Time Frame: Participants will be followed starting on Day +1 post-transplant until they are discharged from the hospital, an expected average of 3-4 weeks. ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02326675
|United States, Florida|
|UF Health Shands Cancer Hopsital|
|Gainesville, Florida, United States, 32608|
|Principal Investigator:||Jamie Dees, RN||UF Health|