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

City of Hope

Status: Enrolling

Conditions: Prostate Carcinoma

Treatments: Other: Best Practice; Other: Survey Administration; Procedure: Oral Cryotherapy

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT07218718

24904 (Other Identifier)

P30CA033572 (U.S. NIH Grant/Contract)

NCI-2025-07271 (Registry Identifier)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 60 estimated patients

Sex: Male

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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60 participants in 2 patient groups

Arm I (oral cryotherapy)

Experimental group

Description:

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.

Treatment:

Procedure: Oral Cryotherapy

Other: Survey Administration

Arm II (best practice)

Active Comparator group

Description:

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.

Treatment:

Other: Survey Administration

Other: Best Practice