A Phase 2 interventional study of Best Practice and Cilostazol in Cervical Carcinoma, Fallopian Tube Carcinoma and Malignant Solid Neoplasm, sponsored by Emory University. Recruiting at 3 sites in United States. Open to female participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-08-27.
Sponsored by Emory University · Phase 2, Interventional, and Supportive care
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.
PRIMARY OBJECTIVES:
I. To quantify the incidence and severity of peripheral neuropathy in women treated with paclitaxel for gynecologic malignancies in conjunction with cryocompression and to assess the impact of cilostazol on the development of peripheral neuropathy. (ARM A and ARM B) II. To quantify the baseline post-chemotherapy neuropathy rates among patients with gynecologic malignancies following standard clinical care practices according to their treating physician. (ARM C)
SECONDARY OBJECTIVES:
I. To estimate the potential impact of cilostazol on quality of life related to chemotherapy-induced peripheral neuropathy.
II. To estimate the potential impact of cilostazol on the need for pharmacologic symptom management for peripheral neuropathy.
III. To estimate the potential impact of cilostazol on chemotherapy dose reductions and delays due to peripheral neuropathy.
IV. To assess the safety of using cilostazol in conjunction with chemotherapy regimens with platinum/paclitaxel with or without VEGF inhibition, with or without immunotherapy, and with or without HER2-directed therapy.
OUTLINE: Participants are assigned to 1 of 3 arms.
ARM A: Patients receive paclitaxel infusion once daily (QD) and receive cryocompression therapy with cooling compression wraps three times daily (TID) over 15 minutes before, during, and after receiving paclitaxel infusion on day 1 of each cycle. Patients also receive cilostazol orally (PO) twice daily (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.
ARM B: 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 for up to 6-9 cycles in the absence of disease progression or unacceptable toxicity.
ARM C: Patients undergo standard of care throughout the study.
After completion of study treatment, patients are followed up at 30 days and then up to 1 year.
Inclusion Criteria:
Exclusion Criteria:
Hepatic impairment, moderate to severe (Class B \& C by Child-Pugh score)
Pregnant and nursing patients
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.
Device: Cryocompression Therapy · Drug: Paclitaxel · Other: Quality-of-Life Assessment
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.
Drug: Cilostazol · Device: Cryocompression Therapy · Drug: Paclitaxel · Other: Quality-of-Life Assessment
Patients undergo standard of care throughout the study.
Other: Best Practice · Other: Quality-of-Life Assessment
Undergo standard of care
Also known as: standard of care, standard therapy
Given PO
Also known as: Pletal
Undergo cryocompression therapy
Given by infusion
Also known as: Anzatax, Asotax, Bristaxol, Praxel, Taxol, Taxol Konzentrat
Ancillary studies
Also known as: Quality of Life Assessment
Difference in sensation and vibration objective neuropathy scores (Arms A and B)
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.
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)
The proportion of patients in Arm C will be tabulated with associated Clopper-Pearson 95% confidence intervals.
Time frame: At 1 month post chemotherapy completion and at 6 months and 12 months
Difference in sensation and vibration objective neuropathy scores
Specifically, the outcome of interest 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 using a chi-square test of independence.
Time frame: At 1 month post chemotherapy completion and at 6 months and 12 months
Difference in >= grade 2 neuropathy between the two study arms
Will be compared between treatment groups using a chi-square test of independence.
Time frame: At 1 month post chemotherapy completion and at 6 months and 12 months
Changes in Functional Assessment of Cancer Therapy/Gynecologic Oncology Group- Neurotoxicity (FACT/GOG-NTX) scores
Will be compared between treatment groups using a chi-square test of independence, as will the proportion of patients experiencing a clinically significant change in FACT/GOG-O-NTX neuropathy scores. Proportion of patients with a clinically significant change in scores (change of 10% or more from baseline) will also be determined.
Time frame: At 1 month post chemotherapy completion and at 6 months and 12 months
Differences in the rate of patients starting new pharmacologic therapy for peripheral neuropathy while receiving paclitaxel chemotherapy
Time frame: At 1 month post chemotherapy completion and at 6 months and 12 months
Differences in the rate of patients requiring paclitaxel dose reductions or chemotherapy delays due to peripheral neuropathy
Time frame: At 1 month post chemotherapy completion and at 6 months and 12 months
Rate of grade 3 adverse events
Will be tabulated by group according to Common Terminology Criteria for Adverse Events Grade, System Organ Class and relation to study treatment.
Time frame: At 1 month post chemotherapy completion and at 6 months and 12 months
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Emory University