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Cryocompression for Gynecologic Cancer

N/A
Waitlist Available
Led By Laura Havrilesky, MD, MHSc
Research Sponsored by Duke University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline, after each dose of paclitaxel and cryocompression, and one month after completion of chemotherapy.
Awards & highlights

Study Summary

This trial is testing whether cryocompression therapy can reduce chemotherapy-induced peripheral neuropathy in gynecologic cancer patients.

Eligible Conditions
  • Peripheral Neuropathy
  • Gynecologic Cancers

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline, one month after completion of chemotherapy.
This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline, one month after completion of chemotherapy. 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 Patient Neurotoxicity Questionnaire [PNQ] (patient reported assessment) over time
Change in Semmes-Weinstein monofilament test (tactile disturbance) over time
Secondary outcome measures
Acceptability: scale
Change in Functional Assessment of Cancer Therapy (FACT) -Taxane [FACT-NTX] (patient reported assessment) over time
Tolerability of cryocompression: scale

Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: CryocompressionExperimental Treatment1 Intervention
Patients will be randomized to receive cryocompression on one hand and foot using ice bags and compression socks.
Group II: ControlActive Control1 Intervention
Patients will be randomized to receive no intervention on the opposite hand and foot.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Cryocompression
2021
N/A
~220

Find a Location

Who is running the clinical trial?

Duke UniversityLead Sponsor
2,365 Previous Clinical Trials
3,420,549 Total Patients Enrolled
Laura Havrilesky, MD, MHScPrincipal InvestigatorDuke University Hospital

Media Library

Cryocompression Clinical Trial Eligibility Overview. Trial Name: NCT04563130 — N/A
Peripheral Neuropathy Research Study Groups: Cryocompression, Control
Peripheral Neuropathy Clinical Trial 2023: Cryocompression Highlights & Side Effects. Trial Name: NCT04563130 — N/A
Cryocompression 2023 Treatment Timeline for Medical Study. Trial Name: NCT04563130 — N/A

Frequently Asked Questions

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

Does this test have any open spots for new participants?

"The clinicaltrial.gov portal states that this trial is not currently accepting new participants, but it was initially posted on November 1st 2021 and updated most recently on May 20th 2022. Fortunately, there are 232 other trials actively seeking patients at the moment."

Answered by AI

Who else is applying?

What state do they live in?
California
How old are they?
18 - 65
What portion of applicants met pre-screening criteria?
Did not meet criteria
Recent research and studies
clinicaltrials.govStudy
Cryocompression to Reduce Chemotherapy-induced Peripheral Neuropathy in Gynecologic Cancer
2021. "Cryocompression to Reduce Chemotherapy-induced Peripheral Neuropathy in Gynecologic Cancer". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04563130.
~21 spots leftby May 2025
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