Cryocompression With or Without Cilostazol for the Prevention of Paclitaxel-induced Neuropathy in Patients With Gynecological Cancers

Part of paid clinical trials in Atlanta, Georgia.

Sponsor
Emory University
Study ID
NCT06492070
Phase
PHASE2
Status
Recruiting
Apply to this trial

Conditions

Eligibility Criteria

Sex
FEMALE
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Best Practice — OTHER
    Undergo standard of care
  • Cilostazol — DRUG
    Given PO
  • Cryocompression Therapy — DEVICE
    Undergo cryocompression therapy
  • Paclitaxel — DRUG
    Given by infusion
  • Quality-of-Life Assessment — OTHER
    Ancillary studies

Study Details

The phase II trial evaluates the effectiveness of cryocompression therapy alone or in combination with cilostazol in preventing paclitaxel-induced peripheral neuropathy (numbness, pain or tingling in the feet and hands) for patients with gynecologic cancers. Peripheral neuropathy is a common side effect of many chemotherapeutic agents, including paclitaxel. Paclitaxel is in a class of medications called antimicrotubule agents. It stops cancer cells from growing and dividing and may kill them. Cryocompression is a therapy that combines compression garments or dressings with cooling of the treated area. Cilostazol is in a class of medications called platelet-aggregation inhibitors (antiplatelet medications). It works by improving blood flow to the legs. Giving cilostazol together with cryocompression may be safe and tolerable in treating patients with gynecological cancers.

Key Dates

Start date
Aug 1, 2024
Status verified
Aug 2025
Primary completion
Dec 31, 2026
Completion
Dec 31, 2027

Study Design

Enrollment
70 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE

Arms

  • Experimental: Arm 2 (cryocompression)
    Patients receive paclitaxel infusions QD and receive cryocompression therapy with cooling compression wraps TID for 15 minutes before, during, and after receiving paclitaxel infusions on day 1 of each cycle. Treatment with paclitaxel continues up to 6-9 cycles in the absence of disease progression or unacceptable toxicity.
  • Experimental: Arm A (cryocompression and cilostazol)
    Patients receive paclitaxel infusion QD and receive cryocompression therapy with cooling compression wraps TID over 15 minutes before, during, and after receiving paclitaxel infusion on day 1 of each cycle. Patients also receive cilostazol PO BID beginning with their first paclitaxel infusion continuing until 2 weeks after the final paclitaxel infusion. Treatment with paclitaxel continues for up to 6-9 cycles in the absence of disease progression or unacceptable toxicity.
  • Active Comparator: Arm C (standard of care)
    Patients undergo standard of care throughout the study.

Primary Outcome Measure

Difference in sensation and vibration objective neuropathy scores (Arms A and B) [ Time Frame: At 1 month post chemotherapy completion and at 6 months and 12 months ]

Central Contacts

Locations (3)

FacilityCityStateZIPSite coordinators
Emory Saint Joseph's HospitalAtlantaGeorgia30342
Susan Modesitt, MD
[email protected]
404-727-9578
Emory University Hospital MidtownAtlantaGeorgia30308
Susan Modesitt, MD
[email protected]
404-727-9578
Emory University Hospital/Winship Cancer InstituteAtlantaGeorgia30322
Susan C. Modesitt
[email protected]
404-727-9578
Susan C. Modesitt (PRINCIPAL_INVESTIGATOR)

Find similar trials in Atlanta, GA

By condition
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By specialty
OncologyGynecologic oncologyWomen's health
By research site
Emory Saint Joseph's Hospital· Atlanta, GAEmory University Hospital Midtown· Atlanta, GAEmory University Hospital/Winship Cancer Institute· Atlanta, GA

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