Actively Recruiting
Cryocompression With or Without Cilostazol for the Prevention of Paclitaxel-induced Neuropathy in Patients With Gynecological Cancers
Led by Emory University · Updated on 2025-08-27
70
Participants Needed
3
Research Sites
178 weeks
Total Duration
On this page
Sponsors
E
Emory University
Lead Sponsor
N
National Cancer Institute (NCI)
Collaborating Sponsor
AI-Summary
What this Trial Is About
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
Official Title
Cryocompression With or Without Cilostazol for the Prevention of Paclitaxel-induced Neuropathy in Patients With Gynecological Cancers
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 18 years or older
- Diagnosis of uterine, ovarian/fallopian tube/primary peritoneal, cervical, or vulvar cancer
- 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 (for Arms A and B)
- Eastern Cooperative Oncology Group performance status of 0 to 2
- Completion of 6-9 cycles of paclitaxel and carboplatin or cisplatin chemotherapy with or without VEGF inhibition, immunotherapy, or HER2-directed therapy within the last 3 months (for Arm C)
You will not qualify if you...
- Unable or unwilling to follow all study protocols
- Previous treatment with paclitaxel
- Baseline neuropathy requiring medication
- Diabetes mellitus with hemoglobin A1c over 7.0
- Moderate to severe liver impairment (Child-Pugh Class B or C), excluding slight or moderate malignant ascites alone
- Raynaud's phenomenon
- Active wounds on hands or feet
- High risk uncontrolled arrhythmias
- Ischemic heart disease
- Low white blood count (<4,000/mm3) or low platelet count (<100,000/mm3)
- Elevated bilirubin (>=1.5 mg/dL)
- Elevated creatinine (>=1.5 mg/dL)
- Use of antiplatelet therapies other than acetylsalicylic acid
- Hypersensitivity to cilostazol
- Pregnant or nursing patients
- Incarcerated patients
- Unable to consent due to cognitive impairment or other reasons
- Contraindications to cilostazol
- Not eligible for chemotherapy
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 3 locations
1
Emory University Hospital Midtown
Atlanta, Georgia, United States, 30308
Actively Recruiting
2
Emory University Hospital/Winship Cancer Institute
Atlanta, Georgia, United States, 30322
Not Yet Recruiting
3
Emory Saint Joseph's Hospital
Atlanta, Georgia, United States, 30342
Not Yet Recruiting
Research Team
S
Susan Modesitt, MD
CONTACT
S
Sharese Windley
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
SUPPORTIVE_CARE
Number of Arms
3
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