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

GI Patients on Oxaliplatin Containing Regimen Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT03427021
• Other study ID #: UPCC 28216
• Status: Terminated
• Phase: Early Phase 1
• Start date: February 1, 2017
• Est. completion date: October 23, 2018

Study information

• Verified date: April 2020
• Source: Abramson Cancer Center of the University of Pennsylvania
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 65
• Est. completion date: October 23, 2018
• Est. primary completion date: October 23, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• GI Patients on Oxaliplatin Containing Regimen
• Hypersensitivity

Intervention

Drug:
• Oxaliplatin
Infusion

Locations

Country	Name	City	State
United States	Abramson Cancer Center of the University of Pennsylvania	Philadelphia	Pennsylvania

Sponsors (1)

Lead Sponsor	Collaborator
Abramson Cancer Center of the University of Pennsylvania

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	overall intraoral cold sensitivity score	graded 0 to 4	a minimum of four cycles (2 months) and a maximum of 12 cycles (6 months)