GI Patients on Oxaliplatin Containing Regimen
Conditions
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.
Interventions
DRUGOxaliplatin
Infusion
Sponsors
Abramson Cancer Center at Penn Medicine
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| overall intraoral cold sensitivity score | a minimum of four cycles (2 months) and a maximum of 12 cycles (6 months) | graded 0 to 4 |
Countries
United States
Outcome results
None listed