Protocol Summary

Protocol No.: OCR13905

Sponsor Protocol No.: UF-BMT-CRYO-101

Study Title
Randomized controlled, open-label study on the use of cryotherapy in the prevention of chemotherapy-induced mucositis in stem cell transplant patients

Principal Investigator(s)
Dees, Jamie

Objective
The purpose of this study are to assess the tolerability of cryotherapy given during chemotherapy administration and to determine the efficacy of cryotherapy in reducing etoposide-induced mucositis.

Description
Standard Mouth Care plus Cryotherapy (Group A): Will receive the standard mouth care plus Cryotherapy and will consist of:
- Mouth care 3 times daily with a soft-bristle toothbrush or foam toothbrush
- Cryotherapy - beginning 15 minutes before etoposide chemotherapy starts, the consumption of ice chips and/or other very cold and frozen foods (popsicles, Italian Ice etc.) continuously for 30 minutes. Short (1 to 3 minutes maximum) breaks over the course of the 30 minute period as long as at least 15 minutes are spent actively engaged in the cryotherapy
- Saline "swish and spit" mouth rinses - you will be asked to rinse your mouth with saline for approximately 30 seconds before spitting out the saline into the sink or basin. You will be asked to do this 3 times over 15 minutes following each 30 minute period of cryotherapy
- The cycle of 30 minutes of cryotherapy followed by 15 minutes of saline mouth rinses will be repeated until 30 minutes after the etoposide infusion (approximately 3 cycles for a typical 120 minute infusion).

Standard Mouth Care (Group B): Randomization to the Standard Mouth Care group will consist of:
- Mouth care 3 times daily with a soft-bristle toothbrush or foam toothbrush
- Saline "swish and spit" mouth rinse - rinse the mouth with saline for approximately 30 seconds before spitting out the saline into the sink or basin
- At the beginning of each etoposide infusion, perform three 30-second saline rinses over 15 minutes followed by a 30-minute break from the rinses
- The cycle of 15-minute saline mouth rinses followed by 30-minute break periods will be repeated until 30 minutes after the etoposide infusion (approximately 3 cycles for a typical 120 minute infusion).

The standard mouth care group, will not be permitted to eat ice chips or consume frozen foods during the times these times.

All groups will have the following interventions and assessments performed:
- Mouth Care Diary - the time and type of mouth care and/or cryotherapy
- Mucositis Assessments - pain levels, appetite, ability to swallow liquids and/or food

Phase: Pilot

Age Group: Adult

Scope: Local

Treatment
Group A (Intervention Group) - Standard oral care and cryotherapy.
Group B (Control Group) - Standard oral care.

Detailed Eligibility
Inclusion Criteria:
1. Subjects age 18 year old or older who are eligible candidates for myeloablative autologous stem cell transplantation (ASCT).
2. Subjects receiving etoposide as part of their conditioning regimen with a planned total dose of at least 30 mg/kg.

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

Applicable Disease Sites
Stem Cell Transplant

Participating Institutions
UF Gainesville : Zachary Hudson

Contact
Zachary Hudson
Phone: +1 352-294-8907

Email: zachary.hudson@medicine.ufl.edu

More Information:
View study listing on ClinicialTrials.gov
http://www.clinicaltrials.gov/ct2/show/
NCT02326675