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

Abramson Cancer Center at Penn Medicine logo

Abramson Cancer Center at Penn Medicine

Status and phase

Terminated
Early Phase 1

Conditions

GI Patients on Oxaliplatin Containing Regimen

Treatments

Drug: Oxaliplatin

Study type

Interventional

Funder types

Other

Identifiers

NCT03427021
UPCC 28216

Details and patient eligibility

About

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.

Enrollment

65 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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.

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

65 participants in 2 patient groups

Arm A
Experimental group
Description:
will be treated with consistent exposure to oral ice
Treatment:
Drug: Oxaliplatin
Arm B
Active Comparator group
Description:
Will not be treated with consistent exposure to oral ice.
Treatment:
Drug: Oxaliplatin

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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