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

Sponsor
Abramson Cancer Center of the University of Pennsylvania (Other)
Overall Status
Terminated
CT.gov ID
NCT03427021
Collaborator
(none)
65
1
2
20.7
3.1

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

Study Type:
Interventional
Actual Enrollment :
65 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
A Randomized Study to Establish the Efficacy of Oral Ice Exposure During Oxaliplatin Infusion in Preventing Oral Cold Sensitivity
Actual Study Start Date :
Feb 1, 2017
Actual Primary Completion Date :
Oct 23, 2018
Actual Study Completion Date :
Oct 23, 2018

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

  1. 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

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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.
Responsible Party:
Abramson Cancer Center of the University of Pennsylvania
ClinicalTrials.gov Identifier:
NCT03427021
Other Study ID Numbers:
  • UPCC 28216
First Posted:
Feb 9, 2018
Last Update Posted:
Apr 8, 2020
Last Verified:
Apr 1, 2020
Studies a U.S. FDA-regulated Drug Product:
Yes
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Apr 8, 2020