Oral Cryotherapy for Prostate Cancer

Age: 18+

Sex: Male

Trial Phase: Academic

Sponsor: City of Hope Medical Center

Must be taking: Taxane chemotherapy

Must not be taking: Oxaliplatin

Disqualifiers: Pre-existing taste alterations, oral surgery, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 1

Duration: 3 weeks

60 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores whether sucking on popsicles during chemotherapy can reduce taste changes in prostate cancer patients. Chemotherapy, especially with taxane drugs, often alters taste, frustrating patients. Cooling the mouth with popsicles (oral cryotherapy) might reduce blood flow to the taste buds, potentially limiting these changes. Prostate cancer patients starting taxane chemotherapy for the first time might be suitable candidates if they are willing to use popsicles during treatment. As an unphased trial, this study offers a unique opportunity to explore a simple, non-invasive method to improve quality of life during treatment.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It focuses on using popsicles to reduce taste changes during chemotherapy.

What prior data suggests that oral cryotherapy is safe for prostate cancer patients?

Research has shown that cooling the mouth with popsicles or ice chips, known as oral cryotherapy, is generally safe for patients. This method helps reduce side effects like changes in taste for those receiving chemotherapy. One study found that cryotherapy lessened severe mouth sores, but the results were not strong enough to prove its full effectiveness. However, the treatment did not cause any major safety issues. This suggests that oral cryotherapy is well-tolerated by patients, making it a potentially safe option to try. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Oral cryotherapy is unique because it offers a non-invasive approach to managing side effects during prostate cancer treatment, specifically taxane chemotherapy. Unlike standard treatments that focus on medication and surgery, this method involves patients sucking on a popsicle for a short period, which is believed to reduce the chances of chemotherapy-induced mouth sores. Researchers are excited about this because it could enhance patient comfort and improve the overall chemotherapy experience without adding new drugs or complex interventions. If effective, it represents a simple, accessible strategy to mitigate a common and debilitating side effect of prostate cancer treatment.

What evidence suggests that oral cryotherapy is effective for reducing taste changes in prostate cancer patients receiving taxane chemotherapy?

Research has shown that oral cryotherapy, which involves cooling the mouth with popsicles or ice chips, can reduce taste changes in patients receiving chemotherapy. This method narrows small blood vessels in the mouth, decreasing the amount of chemotherapy that reaches taste-sensitive areas. Early findings suggest it can lessen taste disturbances, a common side effect for patients undergoing taxane-based chemotherapy. In this trial, participants in one arm will undergo oral cryotherapy, while those in another arm will receive usual care without ice or popsicles. Although limited data exists specifically for prostate cancer patients, similar techniques have effectively reduced mouth-related side effects in other types of chemotherapy. This approach aims to provide a simple, non-invasive way to improve patients' quality of life during treatment. ^{1 2 6 7 8}

Who Is on the Research Team?

Jeannine M Brant

Principal Investigator

City of Hope Medical Center

Are You a Good Fit for This Trial?

This trial is for prostate cancer patients undergoing taxane chemotherapy who are experiencing taste changes. The study aims to determine if oral cryotherapy, like sucking on popsicles, can help reduce these taste alterations.

Inclusion Criteria

I have been diagnosed with prostate cancer.

I am 18 years old or older.

I am starting treatment with taxane chemotherapy alone.

Exclusion Criteria

I do not have taste issues, oral surgery, or malformations that could affect the study. I am not receiving oxaliplatin.

I am currently receiving oxaliplatin chemotherapy.

I have changes in my sense of taste.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants undergo oral cryotherapy with popsicles during the first taxane chemotherapy cycle

3 weeks

Visits aligned with chemotherapy sessions

Follow-up

Participants are monitored for changes in taste perception and CiTAS score after the first chemotherapy cycle

1 week

1 visit (in-person)

What Are the Treatments Tested in This Trial?

Interventions

• Oral Cryotherapy

Trial Overview The intervention being tested is oral cryotherapy—cooling the mouth with cold items such as ice chips or popsicles during chemotherapy—to see if it lessens the impact of chemo on patients' sense of taste.

How Is the Trial Designed?

Group I: Arm I (oral cryotherapy) Experimental Treatment 2 Interventions

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 II: Arm II (best practice) Active Control 2 Interventions

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.

Who Is Running the Clinical Trial?

City of Hope Medical Center

Lead Sponsor

Trials

614

Recruited

1,924,000+

National Cancer Institute (NCI)

Collaborator

Trials

14,080

Recruited

41,180,000+

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12227874/

Current Status of Cryoablation in Prostate Cancer ... The data from a systematic review included 24 papers that examined oncological outcomes of the focal cryotherapy.

2. clinicaltrials.gov clinicaltrials.gov/study/NCT07218718

Oral Cryotherapy to Decrease Taste Changes in Prostate ... This clinical trial studies whether cooling the mouth with popsicles (oral cryotherapy) decreases taste changes in prostate cancer patients ...

3. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC3945790/

Cryotherapy for Primary Treatment of Prostate Cancer Erectile disfunction was found in 98.1%. Conclusions. Cryotherapy is an effective and minimally invasive treatment for primary PC in well-selected cases, with ...

4. tandfonline.com tandfonline.com/doi/full/10.1080/13685538.2020.1796960

Primary cryotherapy for localized prostate cancer treatment The available data indicate that focal cryotherapy seems to result in acceptable medium-term oncological outcomes with favorable morbidity profiles. The largest ...

5. healthline.com healthline.com/health/prostate-cancer/cryotherapy-for-prostate-cancer

Cryotherapy for Prostate Cancer: Efficacy, Side Effects, More A 2020 studyTrusted Source found that cryotherapy achieved similar results to radical prostatectomy, which is surgery to remove your prostate.

6. atm.amegroups.org atm.amegroups.org/article/view/87482/html

Focal cryotherapy for prostate cancer: a contemporary ... Another study of 82 patients undergoing RP after FT failure demonstrated only a 36% progression-free survival at 3 years but did describe a 12-month continence ...

7. mdpi.com mdpi.com/2072-6694/15/15/3873

Primary Total Prostate Cryoablation for Localized High- ... The metastasis-free, cancer-specific, and overall survival rates were 89.5%, 97.4%, and 90.5% at 10 years, respectively. The variables in the pre-operative ...

8. ascopubs.org ascopubs.org/doi/10.1200/JCO.2024.42.17_suppl.LBA12134

A randomized trial to assess the effect of oral cryotherapy ... Conclusions: Although cryotherapy reduced the incidence of grade 3-5 mucositis, it was not significant and its efficacy was not established.