Oral Cryotherapy to Decrease Taste Changes in Prostate Cancer Patients Receiving Taxane Chemotherapy

Purpose

This clinical trial studies whether cooling the mouth with popsicles (oral cryotherapy) decreases taste changes in prostate cancer patients receiving taxane chemotherapy. Patients receiving chemotherapy can experience a variety of side effects. Changes in the taste of food is a frequent complaint of patients receiving chemotherapy and is underreported as patients may think that it is unavoidable and not manageable. Taxane-based chemotherapy is thought to be associated with the most taste changes of any chemotherapy. Taste buds contain a specific type of cell, called gustatory cells, that are located on the surface of the tongue, the soft palate (back, muscular part of the roof of the mouth), and the upper part of the esophagus. These cells consist of five basic tastes: salty, sweet, sour, bitter, and umami (or savory). Oral cryotherapy involves cooling the mouth with ice chips, popsicles, or other cold drinks for several minutes before, during, and after chemotherapy causing the tiny blood vessels in the protective linings inside the mouth to narrow. It is thought that this narrowing will reduce blood flow to the cooled areas, thereby decreasing the amount of chemotherapy that is delivered to the fragile protective linings inside the mouth that causes the taste changes. This may be an effective way to decrease taste changes in prostate cancer patients receiving taxane chemotherapy.

Condition

  • Prostate Carcinoma

Eligibility

Eligible Ages
Over 18 Years
Eligible Sex
Male
Accepts Healthy Volunteers
No

Inclusion Criteria

  • Patients undergoing taxane chemotherapy must be English speaking and have an Eastern Cooperative Oncology Group (ECOG) performance score < 2 - Documented written informed consent of the participant - ONE of the following diagnoses: - Prostate cancer - Age: At least 18 years of age or older - Undergoing initial single agent taxane chemotherapy - Chemotherapy naïve - Willingness to: - Suck on popsicles during chemotherapy infusion - Complete baseline and follow-up surveys

Exclusion Criteria

  • Patients with pre-existing taste alterations, oral surgery, or malformation that may interfere with the study procedure will be excluded. Patients receiving oxaliplatin will be excluded due to oral sensitivity of cold fluids during oxaliplatin administration - Receiving oxaliplatin chemotherapy - Pre-existing taste alterations - Previous oral surgery - Oral malformation

Study Design

Phase
N/A
Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel Assignment
Primary Purpose
Supportive Care
Masking
Double (Investigator, Outcomes Assessor)
Masking Description
The study statistician will generate a password-protected randomization list to ensure blinding. Following completion of baseline questionnaires, the clinical research associate (CRA) will be informed of the group assignment and notify the participant. The study team is blinded to assignment until this point. The CRA will assist with data collection and will not be blinded to group assignment.

Arm Groups

ArmDescriptionAssigned Intervention
Experimental
Arm I (oral cryotherapy) 		Patients undergo oral cryotherapy over 75 minutes and suck on a popsicle for 5 minutes before, during, and for 10 minutes post-infusion throughout first taxane chemotherapy cycle, up to 21 days, in the absence of unacceptable toxicity.
  • Procedure: Oral Cryotherapy
    Undergo oral cryotherapy
  • Other: Survey Administration
    Ancillary studies
Active Comparator
Arm II (best practice) 		Patients receive usual care and are encouraged not to consume ice or popsicles throughout their first taxane chemotherapy cycle, up to 21 days, in the absence of unacceptable toxicity.
  • Other: Best Practice
    Receive usual care
    Other names:
    • standard of care
    • standard therapy
  • Other: Survey Administration
    Ancillary studies

Recruiting Locations

City of Hope Medical Center
Duarte, California 91010
Contact:
Jeannine M. Brant
406-591-3978
jbrant@coh.org

More Details

Status
Recruiting
Sponsor
City of Hope Medical Center

Study Contact

Detailed Description

PRIMARY OBJECTIVE: I. To assess whether use of oral cryotherapy (popsicles) can decrease taste alterations (TAs) during receiving taxane chemotherapy. OUTLINE: Patients are randomized to 1 of 2 arms. ARM I: Patients undergo oral cryotherapy over 75 minutes and suck on a popsicle for 5 minutes before, during, and for 10 minutes post-infusion throughout first taxane chemotherapy cycle, up to 21 days, in the absence of unacceptable toxicity. ARM II: Patients receive usual care and are encouraged not to consume ice or popsicles throughout their first taxane chemotherapy cycle, up to 21 days, in the absence of unacceptable toxicity. After completion of study intervention, patients are followed up prior to cycle 2.