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

NCT ID: NCT03427021

Last Updated: 2020-04-08

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: EARLY_PHASE1
• Total Enrollment: 65 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-02-01
• Study Completion Date: 2018-10-23

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.

Conditions

GI Patients on Oxaliplatin Containing Regimen

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Arm A

will be treated with consistent exposure to oral ice

Group Type: EXPERIMENTAL

Oxaliplatin

Intervention Type: DRUG

Infusion

Arm B

Will not be treated with consistent exposure to oral ice.

Group Type: ACTIVE_COMPARATOR

Oxaliplatin

Intervention Type: DRUG

Infusion

Interventions

Oxaliplatin

Infusion

Intervention Type: DRUG

Eligibility 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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Abramson Cancer Center at Penn Medicine

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Kim Reiss Binder, MD

Role: PRINCIPAL_INVESTIGATOR

Abramson Cancer Center at Penn Medicine

Locations

Abramson Cancer Center of the University of Pennsylvania

Philadelphia, Pennsylvania, United States

Countries

United States

Other Identifiers

UPCC 28216

Identifier Type: -

Identifier Source: org_study_id