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Cryocompression for Gynecologic Cancer

N/A

Recruiting

Led By Laura Havrilesky

Research Sponsored by Duke University

Eligibility Criteria Checklist

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

Must have

Gynecologic cancer diagnosis (ovarian, cervical, endometrial cancer; adenocarcinomas of likely primary gynecologic origin based on cytology or FNA in conjunction with radiologic impression will be eligible)

ECOG (Eastern Cooperative Oncology Group) performance status of 0-1

Must not have

Treated with prior neurotoxic chemotherapeutic agents

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to two months after completion of chemotherapy, an average of 6 months

Awards & highlights

No Placebo-Only Group

Summary

This trial will test if cryotherapy wraps plus compression therapy can help prevent chemo-caused nerve pain in women with gynecologic cancer. It'll also measure patient and staff satisfaction.

Who is the study for?

This trial is for patients with gynecologic cancers (like ovarian, cervical, endometrial) who are set to receive at least 6 cycles of paclitaxel chemotherapy every 3 weeks. They should be in good physical condition as indicated by an ECOG score of 0-1. Those with previous treatments that can affect nerves or existing conditions like diabetic neuropathy aren't eligible.

What is being tested?

The study is testing if using cryotherapy wraps with compression therapy (cryocompression) is as effective as cryotherapy alone in reducing nerve pain and damage caused by chemotherapy in gynecologic cancer patients. It also evaluates patient comfort and satisfaction with the treatment.

What are the potential side effects?

Potential side effects may include discomfort from the cold temperature of cryotherapy, possible skin irritation from compression wraps, and any unforeseen reactions related to combining these therapies during chemotherapy.

Eligibility Criteria

Inclusion Criteria

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

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I have been diagnosed with a type of gynecologic cancer.

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I am fully active or can carry out light work.

Exclusion Criteria

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

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I have been treated with chemotherapy that can affect the nerves.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to two months after completion of chemotherapy, an average of 6 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to two months after completion of chemotherapy, an average of 6 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to two months after completion of chemotherapy, an average of 6 months for reporting.