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| ID | Type | Description | Link |
|---|---|---|---|
| NCI-2025-07271 | Registry Identifier | CTRP (Clinical Trial Reporting Program) | |
| 24904 | Other Identifier | City of Hope Medical Center | |
| P30CA033572 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Cancer Institute (NCI) | NIH |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Arm I (oral cryotherapy) | Experimental | 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 (best practice) | Active Comparator | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Best Practice | Other | Receive usual care |
|
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| Measure | Description | Time Frame |
|---|---|---|
| Change in Chemotherapy-induced Taste Alteration Scale (CiTAS) score | 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). | Baseline (T1) to prior to cycle 2 (T2) (Cycle length = 21 days) |
| Change in taste strip perception | 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. | Baseline to prior to cycle 2 (Cycle length = 21 days) |
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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:
Age: At least 18 years of age or older
Undergoing initial single agent taxane chemotherapy
Chemotherapy naïve
Willingness to:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Jeannine M Brant | City of Hope Medical Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| City of Hope Medical Center | Recruiting | Duarte | California | 91010 | United States |
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| ID | Term |
|---|---|
| D011471 | Prostatic Neoplasms |
| ID | Term |
|---|---|
| D005834 | Genital Neoplasms, Male |
| D014565 | Urogenital Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
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| ID | Term |
|---|---|
| D017410 | Practice Guidelines as Topic |
| D059039 | Standard of Care |
| D017679 | Cryotherapy |
| ID | Term |
|---|---|
| D017408 | Guidelines as Topic |
| D011785 | Quality Assurance, Health Care |
| D011787 | Quality of Health Care |
| D006298 | Health Services Administration |
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The study statistician will generate a password-protected randomization list to ensure blinding. Following completion of baseline questionnaires, the clinical research associate (CRA) will be informed of the group assignment and notify the participant. The study team is blinded to assignment until this point. The CRA will assist with data collection and will not be blinded to group assignment.
| Oral Cryotherapy | Procedure | Undergo oral cryotherapy |
|
| Survey Administration | Other | Ancillary studies |
|
| D005832 |
| Genital Diseases, Male |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D011469 | Prostatic Diseases |
| D052801 | Male Urogenital Diseases |
| D017530 | Health Care Quality, Access, and Evaluation |
| D019984 | Quality Indicators, Health Care |
| D013812 | Therapeutics |