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

A Pilot Study Examining the Feasibility of Oral Cryotherapy (Popsicles) in Decreasing Dysgeusia in Patients With Prostate Cancer Receiving Single Agent Taxane Therapy

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.

Study Overview

• Status: Completed
• Conditions: Prostate Carcinoma
• Intervention / Treatment: Other: Best Practice; Other: Survey Administration; Procedure: Oral Cryotherapy

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.

• Study Type: Interventional
• Enrollment (Actual): 2
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • California
    • Duarte, California, United States, 91010
      • City of Hope Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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.	Other: Survey Administration; Ancillary studies; Procedure: Oral Cryotherapy; Undergo oral cryotherapy
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Chemotherapy-induced Taste Alteration Scale (CiTAS) score	The change score of the CiTAS (total score) from T1 to T2 will be compared between two arms using two sample t test or Kruskal-Wallis test whichever is appropriate. The statistical comparison will be conducted using intent-to-treat. Will use linear mixed model for repeated-measures design to evaluate the group-difference in the changes of CiTAS total score. Model will include time (T1, T2), group (the experimental, control group), group × time interaction, and covariates if necessary. Will evaluate the success of the randomization by examining between arm differences in demographic and clinical characteristics. Variables on which there are significant group differences will be further tested to determine if they meet the assumptions of covariates (chi square or t-test).	Baseline (T1) to prior to cycle 2 (T2) (Cycle length = 21 days)
Change in taste strip perception	Taste strips will be analyzed with descriptive statistics. For the 5 basic tastes, will note the percentage of patients who could taste salty, sour, bitter, sweet, and umami at baseline and prior to cycle 2 and compare results between the two arms.	Baseline to prior to cycle 2 (Cycle length = 21 days)

Collaborators and Investigators

• Sponsor: City of Hope Medical Center
• Collaborators: National Cancer Institute (NCI)
• Investigators: Principal Investigator: Jeannine M Brant, City of Hope Medical Center

Study record dates

Study Major Dates

• Study Start (Actual): December 11, 2025
• Primary Completion (Actual): January 28, 2026
• Study Completion (Actual): June 11, 2026

Study Registration Dates

• First Submitted: October 16, 2025
• First Submitted That Met QC Criteria: October 16, 2025
• First Posted (Actual): October 20, 2025

Study Record Updates

• Last Update Posted (Actual): August 14, 2026
• Last Update Submitted That Met QC Criteria: August 12, 2026
• Last Verified: August 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Urogenital Diseases; Genital Diseases; Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Prostatic Diseases; Male Urogenital Diseases; Prostatic Neoplasms; Health Services Administration; Health Care Quality, Access, and Evaluation; Therapeutics; Quality of Health Care; Quality Indicators, Health Care; Guidelines as Topic; Quality Assurance, Health Care; Standard of Care; Cryotherapy; Practice Guidelines as Topic
• Other Study ID Numbers: 24904 (Other Identifier: City of Hope Medical Center); P30CA033572 (U.S. NIH Grant/Contract); NCI-2025-07271 (Registry Identifier: CTRP (Clinical Trial Reporting Program))

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No