RecruitingPhase 2NCT06492070

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

Prevention of Paclitaxel-Induced Peripheral Neuropathy: Randomized Trial of Cryocompression With or Without Cilostazol

Sponsor

Emory University

Enrollment

70 participants

Start Date

Aug 1, 2024

Study Type

INTERVENTIONAL

Conditions

Ovarian Carcinoma Cervical Carcinoma Malignant Solid Neoplasm Malignant Uterine Neoplasm Primary Peritoneal Carcinoma Fallopian Tube Carcinoma Vulvar Carcinoma

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.

Eligibility

Sex: FEMALEMin Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is testing whether cold compression gloves and socks (cryocompression) — with or without a drug called cilostazol — can prevent nerve damage (peripheral neuropathy) caused by paclitaxel chemotherapy in women with gynecological cancers. Nerve damage is a common and sometimes permanent side effect of paclitaxel. **You may be eligible if...** - You are 18 or older with uterine, ovarian, cervical, or vulvar cancer - You are scheduled for 6–9 cycles of paclitaxel-based chemotherapy - OR you have already completed paclitaxel treatment and are experiencing neuropathy symptoms - Your general health is adequate for chemotherapy (ECOG 0–2) **You may NOT be eligible if...** - You already have significant peripheral neuropathy before starting chemotherapy - You have poor circulation in your hands or feet (like Raynaud's disease) - You have conditions that would make wearing compression devices unsafe - You are pregnant Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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