A Randomized Study to Establish the Efficacy of Oral Ice Exposure During Oxaliplatin Infusion in Preventing Oral Cold Sensitivity
NCT03427021 · Status: TERMINATED · Phase: EARLY_PHASE1 · Type: INTERVENTIONAL · Enrollment: 65
Last updated 2020-04-08
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.
Conditions
- GI Patients on Oxaliplatin Containing Regimen
Interventions
- DRUG
-
Infusion
Sponsors & Collaborators
-
Abramson Cancer Center at Penn Medicine
lead OTHER
Principal Investigators
-
Kim Reiss Binder, MD · Abramson Cancer Center at Penn Medicine
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2017-02-01
- Primary Completion
- 2018-10-23
- Completion
- 2018-10-23
- FDA Drug
- Yes
Countries
- United States
Study Locations
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