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

NCT03427021 | Terminated Early Phase 1 DMC FDA Drug

• 1 other identifier: UPCC 28216
• Study Type: interventional
• Target: 65
• Locations: 1 country
• Sites: 1

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.

Conditions

GI Patients on Oxaliplatin Containing Regimen

Outcome Measures

Primary Outcomes (1)

• overall intraoral cold sensitivity score

  graded 0 to 4

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

Study Arms (2)

Arm A

EXPERIMENTAL

will be treated with consistent exposure to oral ice

Drug: Oxaliplatin

Arm B

ACTIVE COMPARATOR

Will not be treated with consistent exposure to oral ice.

Drug: Oxaliplatin

Interventions

Oxaliplatin DRUG

Infusion

Arm A; Arm B

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Abramson Cancer Center at Penn Medicine: lead

Study Sites (1)

Abramson Cancer Center of the University of Pennsylvania

Philadelphia, Pennsylvania, 19104, United States

Location

MeSH Terms

Interventions

Oxaliplatin

Intervention Hierarchy (Ancestors)

Coordination Complexes; Organic Chemicals

Study Officials

• Kim Reiss Binder, MD

  Abramson Cancer Center at Penn Medicine

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 30, 2018
• First Posted: February 9, 2018
• Study Start: February 1, 2017
• Primary Completion: October 23, 2018
• Study Completion: October 23, 2018
• Last Updated: April 8, 2020

Record last verified: 2020-04

Locations

US (1)