ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT03427021
Recruitment Status : Recruiting
First Posted : February 9, 2018
Last Update Posted : February 9, 2018
Sponsor:
Information provided by (Responsible Party):
Abramson Cancer Center of the University of Pennsylvania

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
GI Patients on Oxaliplatin Containing Regimen Drug: Oxaliplatin Early Phase 1

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 50 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 : February 1, 2017
Estimated Primary Completion Date : February 1, 2020
Estimated Study Completion Date : February 1, 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Allergy
Drug Information available for: Oxaliplatin
U.S. FDA Resources

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



Primary Outcome Measures :
  1. overall intraoral cold sensitivity score [ Time Frame: a minimum of four cycles (2 months) and a maximum of 12 cycles (6 months) ]
    graded 0 to 4



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03427021


Contacts
Contact: Kim Reiss Binder, MD 855-216-0098 PennCancerTrials@emergingmed.com

Locations
United States, Pennsylvania
Abramson Cancer Center of the University of Pennsylvania Recruiting
Philadelphia, Pennsylvania, United States, 19104
Contact: Kim Reiss Binder, MD    855-216-0098    PennCancerTrials@emergingmed.com   
Principal Investigator: Kim Reiss Binder, MD         
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

Responsible Party: Abramson Cancer Center of the University of Pennsylvania
ClinicalTrials.gov Identifier: NCT03427021     History of Changes
Other Study ID Numbers: UPCC 28216
First Posted: February 9, 2018    Key Record Dates
Last Update Posted: February 9, 2018
Last Verified: February 2018

Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
Oxaliplatin
Antineoplastic Agents