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Preventing Neuropathy in Gynecological Cancers with Cryocompression and Cilostazol

This study is looking at ways to prevent a common side effect of paclitaxel chemotherapy called peripheral neuropathy. Peripheral neuropathy causes numbness, pain, or tingling in your hands and feet. The study is testing if cryocompression therapy (cooling and compression of the treated area) alone, or in combination with a medication called cilostazol (which improves blood flow), can reduce this side effect. You may be eligible if you are an adult woman with cervical, fallopian tube, uterine, or ovarian cancer and are scheduled to receive paclitaxel chemotherapy. The study will measure changes in sensation and vibration, and how many people develop significant neuropathy. This study is currently unclear on its recruitment status and plans to enroll 70 participants.

Study design
This is an interventional study with 70 planned participants, comparing cryocompression therapy alone, cryocompression with cilostazol, and standard care.
What's involved
Not specified in the trial record.
Compensation
Not stated in the trial record.
Follow-up
Your sensation and vibration will be measured at 1 month, 6 months, and 12 months after completing chemotherapy.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT06492070

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

Recruiting
PHASE2Ages 18+InterventionalSupportive care
Emory University
~70 participants
Updated 2026-08-27 on ClinicalTrials.gov
What's tested:Best PracticeCilostazolCryocompression TherapyPaclitaxelQuality-of-Life Assessment

At a glance

Recruiting sites
1 of 3 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Difference in sensation and vibration objective neuropathy scores (Arms A and B)
Measured over At 1 month post chemotherapy completion and at 6 months and 12 months
+1 more outcome measured

Conditions

Cervical Carcinoma
Fallopian Tube Carcinoma
Malignant Solid Neoplasm
Malignant Uterine Neoplasm
Ovarian Carcinoma
Primary Peritoneal Carcinoma
Vulvar Carcinoma

Explore related trials

Cervical CarcinomaFallopian Tube CarcinomaMalignant Uterine NeoplasmOvarian CarcinomaPrimary Peritoneal CarcinomaSolid NeoplasmVulvar Carcinoma

Where it's being run

3 sites across 1 states
Georgia3

Study leadership

  • Susan C Modesitt · PRINCIPAL_INVESTIGATOR · Emory University Hospital/Winship Cancer Institute

Who to contact

Susan Modesitt, MD
[email protected]
404-727-9578
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

Age 18 years or older
Diagnosis of uterine, ovarian/fallopian tube/primary peritoneal, cervical, or vulvar cancer and planned chemotherapy regimen of 6-9 cycles of paclitaxel and carboplatin or cisplatin with or without VEGF inhibition, with or without immunotherapy, and with or without HER2-directed therapy
Eastern Cooperative Oncology Group performance status from 0 to 2
ARM C: Age 18 years or older
ARM C: Diagnosis of uterine, ovarian/fallopian tube/primary peritoneal, cervical, or vulvar cancer and completion of 6-9 cycles of a chemotherapy regimen consisting of paclitaxel and carboplatin or cisplatin with or without VEGF inhibition, with or without immunotherapy, and with or without HER2-directed therapy within the last 3 months
ARM C: Eastern Cooperative Oncology Group performance status from 0 to 2

Exclusion

Any patient unable and/or unwilling to cooperate with all study protocols
Previous treatment with paclitaxel
Patients with baseline pre-chemotherapy neuropathy requiring pharmacologic treatment
Diabetes mellitus with hemoglobin A1c \>7.0
Hepatic impairment, moderate to severe (Class B \& C by Child-Pugh score)
Slight or moderate malignant ascites alone will not be considered indicative of hepatic impairment in the absence of other evidence of hepatic disease
Raynaud's phenomenon
Active wounds on the hands or feet
High risk uncontrolled arrhythmias
Ischemic heart disease
Inadequate bone marrow function with white blood count \< 4,000/mm\^3 and platelet count \< 100,000/mm\^3
Inadequate liver function with serum total bilirubin \>= 1.5mg/dL
Inadequate renal function with serum creatinine \>= 1.5mg/dL
On one or more antiplatelet therapies excluding acetylsalicylic acid
Hypersensitivity (e.g. anaphylaxis, angioedema) to cilostazol or any components of cilostazol
Pregnant and nursing patients
Patients enrolled in this study who have the potential to become pregnant (have an intact uterus, ovary(ies), and fallopian tube(s), have not entered menopause, and have regular menses) are required to utilize reliable contraception such as celibacy, hormonal contraception (oral pills, implant, injection, ring or patch), intrauterine device (IUD), condom and/or diaphragm with spermicide
Incarcerated patients
Patients unable to consent for themselves, due to cognitive impairment or other reason
Patients with contraindications to cilostazol
Any patient who does not meet criteria to receive chemotherapy
ARM C: Any patient unable and/or unwilling to cooperate with all study protocols
ARM C: Previous treatment with paclitaxel
ARM C: Patients with baseline pre-chemotherapy neuropathy requiring pharmacologic treatment
ARM C: Diabetes mellitus with hemoglobin A1c \>7.0
ARM C: Pregnant patients
ARM C: Incarcerated patients
ARM C: Patients unable to consent for themselves, due to cognitive impairment or other reason

What this trial measures

  • Difference in sensation and vibration objective neuropathy scores (Arms A and B)At 1 month post chemotherapy completion and at 6 months and 12 months

    Specifically, the primary outcome will be the proportion of patients with abnormal vibration sensation times on at least one great toe or index finger assessed by a validated Neuropathy Assessment instrument. Will be compared between treatment groups (Arms A and B) using a chi-square test of independence.

  • Rates of impaired sensation and vibration on objective neuropathy testing and ≥ Grade 2 neuropathy among patients who recently completed paclitaxel treatment with standard of care treatment protocols (Arm C)At 1 month post chemotherapy completion and at 6 months and 12 months

    The proportion of patients in Arm C will be tabulated with associated Clopper-Pearson 95% confidence intervals.