Recruiting
Phase 2

Cryocompression with Cilostazol

Sponsor:

Emory University

Code:

NCT06492070

Conditions

Cervical Carcinoma

Fallopian Tube Carcinoma

Malignant Solid Neoplasm

Malignant Uterine Neoplasm

Ovarian Carcinoma

Eligibility Criteria

Sex: Female

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Best Practice

Cilostazol

Cryocompression Therapy

Paclitaxel

Quality-of-Life Assessment

Study Details

Brief summary:

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.

Conditions

Cervical Carcinoma

Fallopian Tube Carcinoma

Malignant Solid Neoplasm

Malignant Uterine Neoplasm

Ovarian Carcinoma

Study ID

NCT06492070

Start date

Aug 1, 2024

Status verified date

Aug, 2026

Completion date

Dec 31, 2027

Anticipated

Primary completion date

Dec 31, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: Female

Age: 18+

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • INCLUSION CRITERIA FOR ARMS A and B:
  • 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 Criteria:

  • EXCLUSION CRITERIA FOR ARMS A and B:
  • 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

Study Design

Enrollment

70 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Supportive Care

Interventions and Outcome Measures

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.

Interventions

Best Practice

Undergo standard of care

Cilostazol

Given PO

Cryocompression Therapy

Undergo cryocompression therapy

Paclitaxel

Given by infusion

Quality-of-Life Assessment

Ancillary studies

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 ]
  • 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) [ Time Frame: At 1 month post chemotherapy completion and at 6 months and 12 months ]

Central Contacts and Locations

Central contacts

Susan Modesitt, MD

404-727-9578smodesi@emory.edu

Sharese Windley

404-778-8778sharese.windley@emory.edu

Locations

Emory University Hospital Midtown

Recruiting

Atlanta, Georgia, United States, 30308

Contacts

Susan Modesitt, MD

404-727-9578smodesi@emory.edu

More Information

Sponsor

Emory University

Last update posted

Aug 27, 2026

Last verified

Aug, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Emory University on 2026-08-27.