Actively Recruiting
Prevention of Paclitaxel-Induced Peripheral Neuropathy: Randomized Trial of Cryocompression With or Without Cilostazol
Led by Emory University · Updated on 2025-08-27
70
Participants Needed
3
Research Sites
52 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
Researchers are evaluating cryocompression therapy alone or combined with the drug cilostazol to prevent peripheral neuropathy caused by paclitaxel chemotherapy in women with gynecologic cancers. Peripheral neuropathy is a common side effect that causes numbness, pain, or tingling in the hands and feet. This phase II trial aims to measure how well these treatments reduce neuropathy severity and affect quality of life, symptom management, and chemotherapy dosing. It also assesses the safety of cilostazol with various chemotherapy regimens. Participants are assigned to one of three groups: one receives paclitaxel plus cryocompression and cilostazol; another receives paclitaxel plus cryocompression only; and the third group receives standard care without these therapies. Cryocompression involves cooling compression wraps applied three times daily around the chemotherapy infusion. Cilostazol is taken orally twice daily starting with the first paclitaxel dose until two weeks after the last infusion. Paclitaxel treatment continues for 6 to 9 cycles unless the disease progresses or side effects are unacceptable. During the study, participants undergo neuropathy evaluations using sensation and vibration tests at one, six, and twelve months after chemotherapy ends. Quality of life questionnaires and assessments of symptom treatment and chemotherapy dose changes are also performed. Safety is closely monitored throughout. Follow-up visits occur 30 days post-treatment and continue for up to one year. This allows researchers to track long-term effects and the impact of the therapies on neuropathy and patient well-being.
CONDITIONS
Brief 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 with 6-9 cycles of paclitaxel and carboplatin or cisplatin, with or without VEGF inhibition, immunotherapy, or HER2-directed therapy (Arms A and B)
- Eastern Cooperative Oncology Group performance status of 0 to 2
- For Arm C: completion of 6-9 cycles of the above chemotherapy within the last 3 months
- Eastern Cooperative Oncology Group performance status of 0 to 2 (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 greater than 7.0
- Moderate to severe hepatic impairment (Child-Pugh Class B & C)
- Raynaud's phenomenon
- Active wounds on hands or feet
- High risk uncontrolled arrhythmias
- Ischemic heart disease
- Inadequate bone marrow function (low white blood cells and platelets)
- Elevated liver bilirubin (>= 1.5 mg/dL)
- Elevated serum creatinine (>= 1.5 mg/dL)
- Use of antiplatelet therapies other than acetylsalicylic acid
- Allergy or hypersensitivity to cilostazol
- Pregnant or nursing; must use reliable contraception if able to become pregnant
- Incarcerated individuals
- Unable to provide informed consent due to cognitive impairment or other reasons
- Contraindications to cilostazol
- Not eligible to receive chemotherapy
- Additional exclusions for Arm C: same as above excluding some cilostazol-specific criteria
AI-Screening
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Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Duration of 6-9 paclitaxel cycles (calendar time depending on cycles schedule)
Participants receive up to 6-9 cycles of paclitaxel chemotherapy. Depending on their assigned arm, they may receive cryocompression therapy three times daily around each paclitaxel infusion, and some participants also take cilostazol orally twice daily starting with the first paclitaxel infusion continuing until 2 weeks after the final infusion. Participants in the standard care arm undergo usual treatment without additional interventions.
Paclitaxel infusions on day 1 of each cycle with cryocompression therapy TID around infusions for applicable arms
Duration - Up to 1 year after treatment completion
After treatment completion, participants are followed up to monitor neuropathy symptoms, quality of life, and safety outcomes.
Visits at 30 days, 6 months, and 12 months post chemotherapy completion
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
S
Sharese Windley
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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