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.
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
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
Parallel
Best Practice
Other interventionUndergo standard of care
Cilostazol
DrugGiven PO
Cryocompression Therapy
DeviceUndergo cryocompression therapy
Paclitaxel
DrugGiven by infusion
Quality-of-Life Assessment
Other interventionAncillary studies
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.
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.
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.
Difference in >= grade 2 neuropathy between the two study arms
Will be compared between treatment groups using a chi-square test of independence.
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.
Differences in the rate of patients starting new pharmacologic therapy for peripheral neuropathy while receiving paclitaxel chemotherapy
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Emory University
Lead sponsor
National Cancer Institute (NCI)
Collaborator
