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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

Timeline

Screening 3 weeks

Treatment Varies

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

Awards & highlights

Study 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.Check my eligibility

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.See study design

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.

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.

Treatment Details

Study Objectives

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

Primary outcome measures

Change in Functional Assessment of Cancer Therapy (FACT) -Taxane [FACT-NTX] (patient reported assessment) over time

Secondary outcome measures

Acceptability: scale

Change in Patient Neurotoxicity Questionnaire [PNQ] (patient reported assessment) over time

Chemotherapy Dose

+2 more

Trial Design

2Treatment groups

Experimental Treatment

Group I: CryotherapyExperimental Treatment1 Intervention

Group II: Compression with CryotherapyExperimental Treatment2 Interventions

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Cryotherapy

2011

Completed Phase 4

~2280

Compression

2020

Completed Phase 4

~80

0 / 2Eligibility criteria met

Find a Location

Who is running the clinical trial?

Duke UniversityLead Sponsor

2,364 Previous Clinical Trials

3,420,452 Total Patients Enrolled

Laura HavrileskyPrincipal InvestigatorDUHS

1 Previous Clinical Trials

2,605 Total Patients Enrolled

Frequently Asked Questions

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

Are there current openings for this research project?

"Clinicaltrials.gov confirms that this clinical trial, posted on January 2nd 2024 and last updated November 15th 2023, is inactive in its recruitment of candidates. However, there are 249 other trials actively looking for participants at present."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Cryocompression to Reduce Chemotherapy-induced Peripheral Neuropathy in Gynecologic Cancer - COHORT 2

2024. "Cryocompression to Reduce Chemotherapy-induced Peripheral Neuropathy in Gynecologic Cancer - COHORT 2". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06139458.

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