A Randomized Study to Establish the Efficacy of Oral Ice Exposure During Oxaliplatin Infusion in Preventing Oral Cold Sensitivity

Stopped early · Early Phase 1

Conditions studied: GI Patients on Oxaliplatin Containing Regimen

In brief

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.

Key facts

Study ID

NCT03427021

Run by

Abramson Cancer Center at Penn Medicine

People needed

65

Starts

2017-02-01

Expected to finish

2018-10-23

Last updated by the study team

2020-04-08

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• Abramson Cancer Center of the University of Pennsylvania — Philadelphia, Pennsylvania, United States

Full record on ClinicalTrials.gov

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