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

NCT ID: NCT07218718

Last Updated: 2025-11-18

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-12-10
• Study Completion Date: 2026-09-17

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.

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.

Conditions

Prostate Carcinoma

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: DOUBLE

Study Groups

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.

Group Type: EXPERIMENTAL

Oral Cryotherapy

Intervention Type: PROCEDURE

Undergo oral cryotherapy

Survey Administration

Intervention Type: OTHER

Ancillary studies

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.

Group Type: ACTIVE_COMPARATOR

Best Practice

Intervention Type: OTHER

Receive usual care

Survey Administration

Intervention Type: OTHER

Ancillary studies

Interventions

Best Practice

Receive usual care

Intervention Type: OTHER

Oral Cryotherapy

Undergo oral cryotherapy

Intervention Type: PROCEDURE

Survey Administration

Ancillary studies

Intervention Type: OTHER

Other Intervention Names

standard of care; standard therapy

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: No

Sponsors

National Cancer Institute (NCI)

NIH

Sponsor Role: collaborator

City of Hope Medical Center

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Jeannine M Brant

Role: PRINCIPAL_INVESTIGATOR

City of Hope Medical Center

Locations

City of Hope Medical Center

Duarte, California, United States

Site Status: RECRUITING

Countries

United States

Facility Contacts

Jeannine M. Brant

Role: primary

jbrant@coh.org

406-591-3978

Other Identifiers

NCI-2025-07271

Identifier Type: REGISTRY

Identifier Source: secondary_id

24904

Identifier Type: OTHER

Identifier Source: secondary_id

P30CA033572

Identifier Type: NIH

Identifier Source: secondary_id

View Link

24904

Identifier Type: -

Identifier Source: org_study_id