Popsicles to reduce taste changes during taxane chemotherapy for prostate cancer
A Pilot Study Examining the Feasibility of Oral Cryotherapy (Popsicles) in Decreasing Dysgeusia in Patients With Prostate Cancer Receiving Single Agent Taxane Therapy
This trial sees if sucking popsicles during taxane chemotherapy helps reduce taste changes in men with prostate cancer.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 60 (estimated) |
| Ages | 18 Years and up |
| Sex | Male |
| Sponsor | City of Hope Medical Center Academic / other |
| Drugs / interventions | chemotherapy |
| Locations | 1 site (Duarte, California) |
| Trial ID | NCT07218718 on ClinicalTrials.gov |
What this trial studies
This randomized trial assigns chemotherapy-naïve prostate cancer patients starting a single-agent taxane to either oral cryotherapy with popsicles during infusion or to usual care without ice. The intervention arm involves sucking a popsicle for 5 minutes before and during infusion and for 10 minutes after, applied during the first taxane cycle (up to 21 days). Taste alterations are measured with patient-reported surveys at baseline and before the second cycle to compare changes between groups. Participants must be English-speaking adults with ECOG performance status <2 and are followed up prior to cycle 2.
Who should consider this trial
Good fit: Ideal candidates are adults with prostate cancer who are chemotherapy-naïve, starting a single-agent taxane, English-speaking, have ECOG <2, and are willing to suck popsicles and complete baseline and follow-up surveys.
Not a fit: Patients with pre-existing taste alterations, prior oral surgery or malformations, those receiving oxaliplatin, or those unable to tolerate cold mouth stimuli are unlikely to benefit or be eligible.
Why it matters
Potential benefit: If successful, this low-cost, simple intervention could make food taste better and improve eating and quality of life during taxane chemotherapy.
How similar studies have performed: Oral cryotherapy has shown benefit for some chemotherapy-related oral toxicities and there is preliminary evidence it can reduce taste changes with certain agents, but it remains undertested specifically for taxane-related taste alterations.
Eligibility criteria
Show full inclusion / exclusion criteria
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 this trial is running
Duarte, California
- City of Hope Medical Center — Duarte, California, United States (Recruiting)
Study contacts
- Principal investigator: Jeannine M Brant — City of Hope Medical Center
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.