NCT07218718 · City of Hope Medical Center
Oral Cryotherapy to Decrease Taste Changes in Prostate Cancer Patients Receiving Taxane Chemotherapy
What this study is about
This clinical trial studies whether cooling the mouth with popsicles (taken by mouth cryotherapy) decreases taste changes in prostate cancer patients receiving taxane chemotherapy. Patients receiving chemotherapy can experience a variety of side effects.
View original scientific description
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.
Interventions
OTHER
Best Practice
Receive usual care
PROCEDURE
Oral Cryotherapy
Undergo oral cryotherapy
OTHER
Survey Administration
Ancillary studies
Primary outcome measures
Change in Chemotherapy-induced Taste Alteration Scale (CiTAS) score
Time frame: Baseline (T1) to prior to cycle 2 (T2) (Cycle length = 21 days)
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).
Change in taste strip perception
Time frame: Baseline to prior to cycle 2 (Cycle length = 21 days)
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.
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
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
Where
- Duarte, California
Collaborators
National Cancer Institute (NCI)
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Jul 15, 2026 · Source of record for eligibility and locations