Cryotherapy Gloves for Colon Cancer

Recruiting at 1 trial location

Overseen By Sarah Mendez

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: NYU Langone Health

Must be taking: Capecitabine, Oxaliplatin

Disqualifiers: Peripheral neuropathy, Diabetes, Raynaud's, others

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

Approved in 6 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 5

Duration: 9 weeks

40 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial examines whether special ice pack gloves can help individuals with stage III colon cancer receiving the chemotherapy drug oxaliplatin. The goal is to determine if these gloves can prevent numbness or tingling in the hands and feet, common side effects of the treatment. Participants will be divided into two groups: one will wear the gloves during chemotherapy sessions, and the other will not. Suitable candidates for this trial are those with stage III colon cancer who plan to start a specific chemotherapy regimen and do not have conditions like diabetes or Raynaud's disease.

As an unphased trial, this study provides a unique opportunity to explore innovative ways to enhance comfort during chemotherapy.

Do I need to stop my current medications for the trial?

The trial information does not specify if you need to stop taking your current medications. However, since the trial involves starting a new chemotherapy regimen, it's best to discuss your current medications with the trial team.

What prior data suggests that cryotherapy gloves are safe for colon cancer patients?

Research shows that cryotherapy gloves are generally safe during oxaliplatin chemotherapy. Past studies found these cold therapy gloves to be safe. Most side effects are manageable, with some people experiencing mild and temporary cold sensations.

In more than half of the studies, cryotherapy effectively prevented nerve damage caused by chemotherapy. This indicates that the treatment is not only safe but may also reduce chemotherapy side effects. It is always important to discuss any concerns with a healthcare provider before joining a trial. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about using cryotherapy gloves during oxaliplatin treatment for colon cancer because this approach aims to reduce nerve damage, a common side effect of chemotherapy. Unlike traditional methods that don't address this specific issue, the gloves use ice packs to cool the hands, potentially protecting nerves from the harmful effects of the drug. This non-invasive technique offers a novel way to enhance patient comfort and improve quality of life during treatment.

What evidence suggests that cryotherapy gloves are effective for preventing chemotherapy-induced peripheral neuropathy in colon cancer patients?

This trial will compare cryotherapy gloves with a control group for patients receiving oxaliplatin, a chemotherapy drug. Studies have shown that cryotherapy, which uses cold temperatures, can help manage side effects during cancer treatment. When used with oxaliplatin, cryotherapy gloves have proven safe. Patients report side effects like feeling cold, which are usually easy to handle. While more research is needed, early findings suggest that cryotherapy might help prevent nerve damage caused by chemotherapy. This makes it a promising option for reducing side effects from cancer treatment. ^{1 6 7 8 9}

Who Is on the Research Team?

Sarah Mendez

Principal Investigator

NYU Langone Health

Are You a Good Fit for This Trial?

This trial is for adults over 18 with stage III colon cancer who haven't started chemotherapy yet. They'll be starting a standard chemo treatment called CAPOX. People can't join if they already have nerve damage, diabetes, Raynaud's disease, metabolic syndrome (including high blood pressure and cholesterol), missing upper limbs, or certain autoimmune diseases.

Inclusion Criteria

Willingness to participate in research

I have not received chemotherapy before.

I am starting CAPOX chemotherapy soon.

Exclusion Criteria

I have diabetes.

I have nerve damage in my hands or feet.

I have Raynaud's disease.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive oxaliplatin with or without cryotherapy to prevent peripheral neuropathy

9 weeks

5 visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Cryotherapy
• Oxaliplatin

Trial Overview

The study is testing if wearing cryotherapy gloves helps prevent nerve damage in the hands caused by oxaliplatin, a drug used in chemotherapy for colon cancer patients.

How Is the Trial Designed?

Group I: Cryotherapy Experimental Treatment 1 Intervention

Patients receiving oxaliplatin who are randomized to the Interventional (Cryotherapy) Arm will wear a pair of gloves that has removable ice packs throughout their treatment, starting 15 minutes before and ending 15 minutes after completion of oxaliplatin. These ice packs will be replaced every 30 minutes. The total wearing time of the cryotherapy will be approximately 2 hours.

Group II: Control Active Control 1 Intervention

Patients receiving oxaliplatin who are randomized to the Control Arm will not receive the gloves with removable ice packs throughout their treatment.

Oxaliplatin is already approved in European Union, United States, Canada, Japan, Switzerland, China for the following indications:

Approved in European Union as Eloxatin for:

• Colorectal cancer

Approved in United States as Eloxatin for:

• Colorectal cancer

Approved in Canada as Eloxatin for:

• Colorectal cancer

Approved in Japan as Eloxatin for:

• Colorectal cancer

Approved in Switzerland as Eloxatin for:

• Colorectal cancer

Approved in China as Ai Heng for:

• Colorectal cancer

Who Is Running the Clinical Trial?

NYU Langone Health

Lead Sponsor

Trials

1,431

Recruited

838,000+

Published Research Related to This Trial

Oxaliplatin is an effective treatment for colorectal and advanced ovarian cancers, showing a very good safety profile with low hematotoxicity and manageable gastrointestinal side effects, making it suitable for combination therapy.

While oxaliplatin can cause peripheral sensory neuropathy, this side effect is generally reversible and less severe compared to cisplatin, indicating better overall tolerability in patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Oxaliplatin in practice. Misset, JL.[2022]

Oxaliplatin, when combined with fluorouracil (5-FU), has shown significantly higher response rates (60% or more) in patients with untreated advanced colorectal cancer compared to lower rates when used alone (12% to 24%).

While adding oxaliplatin to 5-FU and leucovorin improves response rates and delays tumor progression, it does not appear to extend overall survival, indicating a need for further research to understand this outcome.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Efficacy of oxaliplatin in the treatment of colorectal cancer. Rothenberg, ML.[2022]

In a study of 80 patients undergoing hyperthermic intraperitoneal chemotherapy (HIPC), those treated with oxaliplatin (OX) experienced significant electrolyte disturbances, including lower sodium levels and higher rates of hyponatremia compared to those treated with mitomycin C (MMC).

Despite these electrolyte issues, the overall complication rates and 30-day mortality were similar between the OX and MMC groups, indicating that while OX may cause predictable disturbances, it does not lead to worse outcomes if monitored and managed properly.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Severe electrolyte disturbances after hyperthermic intraperitoneal chemotherapy: oxaliplatin versus mitomycin C. Rueth, NM., Murray, SE., Huddleston, SJ., et al.[2018]

Citations

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The most common techniques for ablation of liver metastases are surgical resection, cryotherapy, and increasingly in recent years, radiofrequency ablation.

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While clinical trials using cold therapy for cancer treatment are still limited, recent research shows promising results in experimental animal cancer models.

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Cryotherapy Gloves for Colon Cancer

Cryotherapy, when used during oxaliplatin chemotherapy, has shown a good safety profile with manageable side effects like cold-triggered sensations and ...

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While data on cold plunges specifically is limited, recent research suggests that other forms of cold therapy may have a beneficial effect on shrinking tumors.

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Overall, cold therapy was effective in preventing CIPN in more than half of the studies. Cold therapy methods such as cold hilotherapy, frozen gloves and socks, ...

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In this first study on hand/foot-cooling in oxaliplatin alone, hilotherapy significantly reduced the incidence of grade ≥2 OIPN at 12 and 24 weeks.

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trialfinder.panfoundation.org

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Cryotherapy & Oxaliplatin

The primary objective of this study is to determine if cryotherapy is beneficial to patients with colon cancer who are receiving oxaliplatin ...

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annalsofoncology.org

annalsofoncology.org/article/S0923-7534%2819%2935408-0/fulltext

Multicenter randomized controlled trial to evaluate the ...

This study investigated the efficacy and tolerability of wearing frozen gloves (FGs) during chemotherapy to prevent chemotherapy-induced peripheral neuropathy ...