A Randomized Study to Establish the Efficacy of Oral Ice Exposure During Oxaliplatin Infusion in Preventing Oral Cold Sensitivity
Study Details
Study Description
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.
Condition or Disease | Intervention/Treatment | Phase |
---|---|---|
Early Phase 1 |
Study Design
Arms and Interventions
Arm | Intervention/Treatment |
---|---|
Experimental: Arm A will be treated with consistent exposure to oral ice |
Drug: Oxaliplatin
Infusion
|
Active Comparator: Arm B Will not be treated with consistent exposure to oral ice. |
Drug: Oxaliplatin
Infusion
|
Outcome Measures
Primary Outcome Measures
- overall intraoral cold sensitivity score [a minimum of four cycles (2 months) and a maximum of 12 cycles (6 months)]
graded 0 to 4
Eligibility Criteria
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.
Contacts and Locations
Locations
Site | City | State | Country | Postal Code | |
---|---|---|---|---|---|
1 | Abramson Cancer Center of the University of Pennsylvania | Philadelphia | Pennsylvania | United States | 19104 |
Sponsors and Collaborators
- Abramson Cancer Center of the University of Pennsylvania
Investigators
- Principal Investigator: Kim Reiss Binder, MD, Abramson Cancer Center of the University of Pennsylvania
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- UPCC 28216