Status:
TERMINATED
A Randomized Study to Establish the Efficacy of Oral Ice Exposure During Oxaliplatin Infusion in Preventing Oral Cold Sensitivity
Lead Sponsor:
Abramson Cancer Center at Penn Medicine
Conditions:
GI Patients on Oxaliplatin Containing Regimen
Eligibility:
All Genders
18+ years
Phase:
EARLY_PHASE1
Brief Summary
The main purpose of this study is to evaluate whether exposure to ice chips in the mouth (oral ice chips) during oxaliplatin treatment prevents or reduces symptoms of cold sensitivity.
Eligibility Criteria
Inclusion
- Individuals ≥18 years of age will be enrolled.
- Patients must have histologic confirmation of a solid tumor malignancy that will be treated with a regimen that contains full-dose oxaliplatin.
- Patients may be receiving treatment in the neoadjuvant, adjuvant or metastatic setting.
- Patients must be treatment-naïve to platinum-agents at the time of enrollment. Prior treatment with non-platinum agents is permitted.
Exclusion
- Any active intraoral infection, including yeast infection (thrush) or active oral herpes simplex virus at the time of enrollment.
- Patients may not have dentures.
- Patients may not have a disorder that may result in altered taste sensation at baseline. This includes but is not limited to: persistent dry mouth.
Key Trial Info
Start Date :
February 1 2017
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 23 2018
Estimated Enrollment :
65 Patients enrolled
Trial Details
Trial ID
NCT03427021
Start Date
February 1 2017
End Date
October 23 2018
Last Update
April 8 2020
Active Locations (1)
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1
Abramson Cancer Center of the University of Pennsylvania
Philadelphia, Pennsylvania, United States, 19104