Trials / Recruiting

RecruitingNCT06492070

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

Status: Recruiting
Phase: Phase 2
Study type: Interventional
Enrollment: 70 (estimated)

Sponsor: Emory University · Academic / Other
Sex: Female
Age: 18 Years
Healthy volunteers: Not accepted

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.

Detailed 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.

Conditions

Interventions

Type	Name	Description
OTHER	Best Practice	Undergo standard of care
DRUG	Cilostazol	Given PO
DEVICE	Cryocompression Therapy	Undergo cryocompression therapy
DRUG	Paclitaxel	Given by infusion
OTHER	Quality-of-Life Assessment	Ancillary studies

Timeline

Start date: 2024-08-01
Primary completion: 2026-12-31
Completion: 2027-12-31
First posted: 2024-07-09
Last updated: 2025-08-27

Locations

3 sites across 1 country: United States

Regulatory

FDA-regulated drug study

Source: ClinicalTrials.gov record NCT06492070. Inclusion in this directory is not an endorsement.