Preventing Nerve Damage Caused by Paclitaxel in Women With Gynecologic Cancers Using Cryocompression and Cilostazol A Phase 2 Randomized Study Evaluating Cryocompression Therapy With or Without Cilostazol

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.

Cryocompression With or Without Cilostazol for the Prevention of Paclitaxel-induced Neuropathy in Patients With Gynecological Cancers