Back to resultsA Randomized Study to Establish the Efficacy of Oral Ice Exposure During Oxaliplatin Infusion in Preventing Oral Cold Sensitivity
Primary Purpose
GI Patients on Oxaliplatin Containing Regimen
Status
Terminated
Phase
Early Phase 1
Locations
United States
Study Type
Interventional
Intervention
Oxaliplatin
Sponsored by
About this trial
This is an interventional treatment trial for GI Patients on Oxaliplatin Containing Regimen
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.
Sites / Locations
- Abramson Cancer Center of the University of Pennsylvania
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Arm A
Arm B
Arm Description
will be treated with consistent exposure to oral ice
Will not be treated with consistent exposure to oral ice.
Outcomes
Primary Outcome Measures
overall intraoral cold sensitivity score
graded 0 to 4
Secondary Outcome Measures
Full Information
NCT ID
NCT03427021
First Posted
January 30, 2018
Last Updated
April 7, 2020
Sponsor
Abramson Cancer Center at Penn Medicine
1. Study Identification
Unique Protocol Identification Number
NCT03427021
Brief Title
A Randomized Study to Establish the Efficacy of Oral Ice Exposure During Oxaliplatin Infusion in Preventing Oral Cold Sensitivity
Official Title
A Randomized Study to Establish the Efficacy of Oral Ice Exposure During Oxaliplatin Infusion in Preventing Oral Cold Sensitivity
Study Type
Interventional
2. Study Status
Record Verification Date
April 2020
Overall Recruitment Status
Terminated
Why Stopped
final study report has been completed and submitted
Study Start Date
February 1, 2017 (Actual)
Primary Completion Date
October 23, 2018 (Actual)
Study Completion Date
October 23, 2018 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Abramson Cancer Center at Penn Medicine
4. Oversight
Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
GI Patients on Oxaliplatin Containing Regimen
7. Study Design
Primary Purpose
Treatment
Study Phase
Early Phase 1
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
65 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Arm A
Arm Type
Experimental
Arm Description
will be treated with consistent exposure to oral ice
Arm Title
Arm B
Arm Type
Active Comparator
Arm Description
Will not be treated with consistent exposure to oral ice.
Intervention Type
Drug
Intervention Name(s)
Oxaliplatin
Intervention Description
Infusion
Primary Outcome Measure Information:
Title
overall intraoral cold sensitivity score
Description
graded 0 to 4
Time Frame
a minimum of four cycles (2 months) and a maximum of 12 cycles (6 months)
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Kim Reiss Binder, MD
Organizational Affiliation
Abramson Cancer Center at Penn Medicine
Official's Role
Principal Investigator
Facility Information:
Facility Name
Abramson Cancer Center of the University of Pennsylvania
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19104
Country
United States
12. IPD Sharing Statement
Learn more about this trial
A Randomized Study to Establish the Efficacy of Oral Ice Exposure During Oxaliplatin Infusion in Preventing Oral Cold Sensitivity
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