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

• Status: Terminated
• Trial end date: 2018-10-23
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Early Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Abramson Cancer Center of the University of Pennsylvania
• Treatments: Oxaliplatin

Criteria

Inclusion Criteria:

• 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 Criteria:

• 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.