NCT07218718 Oral Cryotherapy to Decrease Taste Changes in Prostate Cancer Patients Receiving Taxane Chemotherapy
| NCT ID | NCT07218718 |
| Status | Recruiting |
| Phase | — |
| Sponsor | City of Hope Medical Center |
| Condition | Prostate Carcinoma |
| Study Type | INTERVENTIONAL |
| Enrollment | 60 participants |
| Start Date | 2025-12-11 |
| Primary Completion | 2027-09-17 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 60 participants in total. It began in 2025-12-11 with a primary completion date of 2027-09-17.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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.
Eligibility 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
Contact & Investigator
Jeannine M Brant
PRINCIPAL INVESTIGATOR
City of Hope Medical Center
Frequently Asked Questions
Who can join the NCT07218718 clinical trial?
This trial is open to male participants only, aged 18 Years or older, studying Prostate Carcinoma. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07218718 currently recruiting?
Yes, NCT07218718 is actively recruiting participants. Visit ClinicalTrials.gov or contact City of Hope Medical Center to inquire about joining.
Where is the NCT07218718 trial being conducted?
This trial is being conducted at Duarte, United States.
Who is sponsoring the NCT07218718 clinical trial?
NCT07218718 is sponsored by City of Hope Medical Center. The principal investigator is Jeannine M Brant at City of Hope Medical Center. The trial plans to enroll 60 participants.