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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.
Full description
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.
Enrollment
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Exclusion criteria
EXCLUSION CRITERIA FOR ARMS A and B:
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
Hepatic impairment, moderate to severe (Class B & C by Child-Pugh score)
Raynaud's phenomenon
Active wounds on the hands or feet
High risk uncontrolled arrhythmias
Ischemic heart disease
Inadequate bone marrow function with white blood count < 4,000/mm^3 and platelet count < 100,000/mm^3
Inadequate liver function with serum total bilirubin >= 1.5mg/dL
Inadequate renal function with serum creatinine >= 1.5mg/dL
On one or more antiplatelet therapies excluding acetylsalicylic acid
Hypersensitivity (e.g. anaphylaxis, angioedema) to cilostazol or any components of cilostazol
Pregnant and nursing patients
Incarcerated patients
Patients unable to consent for themselves, due to cognitive impairment or other reason
Patients with contraindications to cilostazol
Any patient who does not meet criteria to receive chemotherapy
ARM C: Any patient unable and/or unwilling to cooperate with all study protocols
ARM C: Previous treatment with paclitaxel
ARM C: Patients with baseline pre-chemotherapy neuropathy requiring pharmacologic treatment
ARM C: Diabetes mellitus with hemoglobin A1c >7.0
ARM C: Pregnant patients
ARM C: Incarcerated patients
ARM C: Patients unable to consent for themselves, due to cognitive impairment or other reason
Primary purpose
Allocation
Interventional model
Masking
70 participants in 3 patient groups
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Central trial contact
Sharese Windley; Susan Modesitt, MD
Data sourced from clinicaltrials.gov
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