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Alkylating agents

Cryotherapy Gloves for Colon Cancer

N/A

Waitlist Available

Led By Sarah Mendez

Research Sponsored by NYU Langone Health

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Chemotherapy naïve

Planning to initiate Capecitabine + Oxaliplatin (CAPOX) chemotherapy regimen as part of standard of care.

Must not have

Pre-existing diabetes

Pre-existing peripheral neuropathy

Timeline

Screening 3 weeks

Treatment Varies

Follow Up visit 5 (day 63)

Awards & highlights

No Placebo-Only Group

Summary

This trial aims to find out if using cryotherapy is helpful for colon cancer patients receiving oxaliplatin in preventing nerve damage caused by chemotherapy.

Who is the study for?

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.

What is being tested?

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.

What are the potential side effects?

While not directly related to the cryotherapy gloves, oxaliplatin can cause side effects like numbness and tingling in hands and feet (neuropathy), fatigue, diarrhea, nausea and increased risk of infections.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I have not received chemotherapy before.

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I am starting CAPOX chemotherapy soon.

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I have been diagnosed with stage III colon cancer.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have diabetes.

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I have nerve damage in my hands or feet.

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I have Raynaud's disease.

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I have lost an arm or part of my arm.

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I have Guillain-Barre, Lupus, Rheumatoid arthritis, or Sjogren's syndrome.

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I have metabolic syndrome with high blood pressure, high cholesterol, and obesity.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ visit 5 (day 63)

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~visit 5 (day 63)

This trial's timeline: 3 weeks for screening, Varies for treatment, and visit 5 (day 63) for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Proportion of Participants with Peripheral Neuropathy at Visit 2

Proportion of Participants with Peripheral Neuropathy at Visit 3

Proportion of Participants with Peripheral Neuropathy at Visit 4

+1 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: CryotherapyExperimental Treatment1 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: ControlActive Control1 Intervention

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

0 / 9Eligibility criteria met