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TerminatedNCT03427021Updated Apr 8, 2020

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

An Early Phase 1 interventional study of Oxaliplatin in GI Patients on Oxaliplatin Containing Regimen, sponsored by Abramson Cancer Center at Penn Medicine. Terminated at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2020-04-08.

Sponsored by Abramson Cancer Center at Penn Medicine · Early Phase 1, Interventional, and Treatment

Why this study was terminated
final study report has been completed and submitted

From the registry’s dates

  • Primary completion was Oct 2018, 8 years ago, and no results have been posted to the registry.
  • Registered 11 months after the study started (first participant enrolled Feb 2017, registered Jan 2018).
Phase
Early Phase 1
Study type
Interventional
Enrollment
65
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study 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.

02

Conditions studied

  • GI Patients on Oxaliplatin Containing Regimen
03

In context

Lead sponsor

Abramson Cancer Center at Penn Medicine is the lead sponsor of 457 studies on the registry; 84 are open to participants now.

Of its 33 completed or terminated interventional studies of FDA-regulated products, 14 (42%) have results posted.

Browse Abramson Cancer Center at Penn Medicine studies →

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

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.
05

Study design

Phase
Early Phase 1
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
65 participants (actual)

Study arms

  • Experimental
    Arm A

    will be treated with consistent exposure to oral ice

    Drug: Oxaliplatin

  • Active comparator
    Arm B

    Will not be treated with consistent exposure to oral ice.

    Drug: Oxaliplatin

Interventions

06

What researchers measure

Primary outcomes

  1. overall intraoral cold sensitivity score

    graded 0 to 4

    Time frame: a minimum of four cycles (2 months) and a maximum of 12 cycles (6 months)

07

Study locations

1 site
  • Abramson Cancer Center of the University of Pennsylvania
    Philadelphia, Pennsylvania 19104, United States
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Apr 8, 2020, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT03427021
Lead sponsor
Abramson Cancer Center at Penn Medicine
Responsible party
Sponsor
First posted
Feb 9, 2018
Start date
Feb 1, 2017
Primary completion
Oct 23, 2018
Completion
Oct 23, 2018
Last update
Apr 8, 2020

Study contacts

Kim Reiss Binder, MD
principal investigator · Abramson Cancer Center at Penn Medicine

Oversight

Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is terminated, as verified in Apr 2020. You cannot join it, but the record below documents what was studied.

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