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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
Sponsor:
Collaborator:
University of Florida Health
Information provided by (Responsible Party):
University of Florida

Brief Summary:
Oral mucositis is a common complication of cancer therapy. Mucositis results from damage to the mucosal epithelium after delivery of chemotherapy or radiation treatments designed to treat the cancer. A number of treatment factors have been shown to influence the incidence and severity of mucositis, including chemotherapy type and dosage. High-dose chemotherapy before stem cell transplantation can cause severe oral mucositis and is often the side effect that patients find the most difficult to endure. Cryotherapy, keeping ice chips in the mouth during chemotherapy infusion, has been shown to prevent or alleviate mucositis caused by high-dose melphalan alone or given in combinations used in pre-transplant conditioning. One other drug notorious for causing severe mucositis is etoposide (VP-16). The specific aims of the study are: 1) to assess tolerability of cryotherapy given during chemotherapy administration; 2) to determine the efficacy of cryotherapy in reducing etoposide-induced mucositis.

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

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 29 participants
Allocation: Randomized
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

Arm Intervention/treatment
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.
Other: Ice
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.




Primary Outcome Measures :
  1. Number of participants that tolerate cryotherapy during each etoposide infusion [ Time Frame: Up to seven days prior to stem cell transplant. ]
  2. 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. ]


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Ages Eligible for Study:   18 Years to 99 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Subjects age 18 year old or older who are eligible candidates for myeloablative autologous stem cell transplantation (ASCT).
  • Subjects receiving etoposide as part of their conditioning regimen with a planned total dose of ≥ 30 mg/kg.

Exclusion Criteria:

  • Subjects with prior radiation to head & neck region.
  • Subjects with known oropharynx involvement with their malignancy.
  • Subjects with a history of non-compliance or who lack capacity to give informed consent.

Information from the National Library of Medicine

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


Locations
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United States, Florida
UF Health Shands Cancer Hopsital
Gainesville, Florida, United States, 32608
Sponsors and Collaborators
University of Florida
University of Florida Health
Investigators
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Principal Investigator: Jamie Dees, RN UF Health
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Responsible Party: University of Florida
ClinicalTrials.gov Identifier: NCT02326675    
Other Study ID Numbers: IRB201400628
First Posted: December 29, 2014    Key Record Dates
Last Update Posted: December 5, 2018
Last Verified: December 2018

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by University of Florida:
Etoposide
Cryotherapy
Additional relevant MeSH terms:
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Mucositis
Stomatitis
Gastroenteritis
Gastrointestinal Diseases
Digestive System Diseases
Mouth Diseases
Stomatognathic Diseases