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

Early Phase 1

Terminated

• Conditions: GI Patients on Oxaliplatin Containing Regimen
• Interventions: Drug: Oxaliplatin

• Registration Number: NCT03427021
• Lead Sponsor: Abramson Cancer Center at Penn Medicine

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.

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study Start: 2017-02-01
• Study First Submitted: 2018-01-30
• Study First Submitted QC: 2018-02-02
• Study First Posted: 2018-02-09
• Primary Completion: 2018-10-23
• Study Completion: 2018-10-23
• Status Verified: 2020-04
• Last Update Submitted: 2020-04-07
• Last Update Posted: 2020-04-08

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 65

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.

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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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Arm A	Oxaliplatin	will be treated with consistent exposure to oral ice
Arm B	Oxaliplatin	Will not be treated with consistent exposure to oral ice.

Primary Outcome Measures

Name	Time	Method
overall intraoral cold sensitivity score	a minimum of four cycles (2 months) and a maximum of 12 cycles (6 months)	graded 0 to 4

Trial Locations

Locations (1)

Abramson Cancer Center of the University of Pennsylvania; 🇺🇸 Philadelphia, Pennsylvania, United States