Cryocompression With or Without Cilostazol for the Prevention of Paclitaxel-induced Neuropathy in Patients With Gynecological Cancers
NCT Number: NCT06492070
Status: RECRUITING
Study Type: INTERVENTIONAL
Phases: PHASE2
Conditions: Cervical Carcinoma|Fallopian Tube Carcinoma|Malignant Solid Neoplasm|Malignant Uterine Neoplasm|Ovarian Carcinoma|Primary Peritoneal Carcinoma|Vulvar Carcinoma
Interventions: OTHER: Best Practice|DRUG: Cilostazol|DEVICE: Cryocompression Therapy|DRUG: Paclitaxel|OTHER: Quality-of-Life Assessment
Sponsor: Emory University
Collaborators: National Cancer Institute (NCI)
Sex: FEMALE
Age: ADULT, OLDER_ADULT
Enrollment: 70
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: SUPPORTIVE_CARE
Start Date: 2024-08-01
Completion Date: 2027-12-31
Locations: Emory University Hospital Midtown, Atlanta, Georgia, 30308, United States|Emory University Hospital/Winship Cancer Institute, Atlanta, Georgia, 30322, United States|Emory Saint Joseph's Hospital, Atlanta, Georgia, 30342, United States

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.

Primary Outcome Measures: 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., 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., At 1 month post chemotherapy completion and at 6 months and 12 months
Secondary Outcome Measures: 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., 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., 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., 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, 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, 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., At 1 month post chemotherapy completion and at 6 months and 12 months