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Alkylating agents

Cryotherapy for Peripheral Neuropathy

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.

Timeline

Screening 3 weeks

Treatment Varies

Follow Up visit 5 (day 63)

Awards & highlights

Study 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.Check my eligibility

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.See study design

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.

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

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

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 / 3Eligibility criteria met

Find a Location

Who is running the clinical trial?

NYU Langone HealthLead Sponsor

1,369 Previous Clinical Trials

840,469 Total Patients Enrolled

2 Trials studying Peripheral Neuropathy

64 Patients Enrolled for Peripheral Neuropathy

Sarah MendezPrincipal InvestigatorNYU Langone Health

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are there ongoing efforts to actively enroll participants in this trial?

"As per clinicaltrials.gov, recruitment for this investigation is presently closed. Initially listed on April 1st, 2024, the trial's most recent update was on February 21st, 2024. While participation in this specific study is no longer available, there are currently 426 alternative studies welcoming new applicants at present."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Cryotherapy & Oxaliplatin

2024. "Cryotherapy & Oxaliplatin". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06281925.

All > Peripheral Neuropathy