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

NCT ID: NCT06492070

Last Updated: 2025-08-27

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: PHASE2
• Total Enrollment: 70 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-08-01
• Study Completion Date: 2027-12-31

Brief 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

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: NONE

Study Groups

Arm 2 (cryocompression)

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 up to 6-9 cycles in the absence of disease progression or unacceptable toxicity.

Group Type: EXPERIMENTAL

Cryocompression Therapy

Intervention Type: DEVICE

Undergo cryocompression therapy

Paclitaxel

Intervention Type: DRUG

Given by infusion

Quality-of-Life Assessment

Intervention Type: OTHER

Ancillary studies

Arm A (cryocompression and cilostazol)

Patients receive paclitaxel infusion QD and receive cryocompression therapy with cooling compression wraps TID over 15 minutes before, during, and after receiving paclitaxel infusion on day 1 of each cycle. Patients also receive cilostazol PO 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.

Group Type: EXPERIMENTAL

Cilostazol

Intervention Type: DRUG

Given PO

Cryocompression Therapy

Intervention Type: DEVICE

Undergo cryocompression therapy

Paclitaxel

Intervention Type: DRUG

Given by infusion

Quality-of-Life Assessment

Intervention Type: OTHER

Ancillary studies

Arm C (standard of care)

Patients undergo standard of care throughout the study.

Group Type: ACTIVE_COMPARATOR

Best Practice

Intervention Type: OTHER

Undergo standard of care

Quality-of-Life Assessment

Intervention Type: OTHER

Ancillary studies

Interventions

Best Practice

Undergo standard of care

Intervention Type: OTHER

Cilostazol

Given PO

Intervention Type: DRUG

Cryocompression Therapy

Undergo cryocompression therapy

Intervention Type: DEVICE

Paclitaxel

Given by infusion

Intervention Type: DRUG

Quality-of-Life Assessment

Ancillary studies

Intervention Type: OTHER

Other Intervention Names

standard of care; standard therapy; Pletal; Anzatax; Asotax; Bristaxol; Praxel; Taxol; Taxol Konzentrat; Quality of Life Assessment

Eligibility Criteria

Inclusion Criteria

• Age 18 years or older
• Diagnosis of uterine, ovarian/fallopian tube/primary peritoneal, cervical, or vulvar cancer and planned chemotherapy regimen of 6-9 cycles of paclitaxel and carboplatin or cisplatin with or without VEGF inhibition, with or without immunotherapy, and with or without HER2-directed therapy
• Eastern Cooperative Oncology Group performance status from 0 to 2
• ARM C: Age 18 years or older
• ARM C: Diagnosis of uterine, ovarian/fallopian tube/primary peritoneal, cervical, or vulvar cancer and completion of 6-9 cycles of a chemotherapy regimen consisting of paclitaxel and carboplatin or cisplatin with or without VEGF inhibition, with or without immunotherapy, and with or without HER2-directed therapy within the last 3 months
• ARM C: Eastern Cooperative Oncology Group performance status from 0 to 2

Exclusion Criteria

• 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)

• Slight or moderate malignant ascites alone will not be considered indicative of hepatic impairment in the absence of other evidence of hepatic disease
• 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

• Patients enrolled in this study who have the potential to become pregnant (have an intact uterus, ovary(ies), and fallopian tube(s), have not entered menopause, and have regular menses) are required to utilize reliable contraception such as celibacy, hormonal contraception (oral pills, implant, injection, ring or patch), intrauterine device (IUD), condom and/or diaphragm with spermicide
• 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

National Cancer Institute (NCI)

NIH

Sponsor Role: collaborator

Emory University

OTHER

Sponsor Role: lead

Responsible Party

Susan Modesitt

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Susan C Modesitt

Role: PRINCIPAL_INVESTIGATOR

Emory University Hospital/Winship Cancer Institute

Locations

Emory University Hospital Midtown

Atlanta, Georgia, United States

Site Status: RECRUITING

Emory University Hospital/Winship Cancer Institute

Atlanta, Georgia, United States

Site Status: NOT_YET_RECRUITING

Emory Saint Joseph's Hospital

Atlanta, Georgia, United States

Site Status: NOT_YET_RECRUITING

Countries

United States

Central Contacts

Susan Modesitt, MD

Role: CONTACT

smodesi@emory.edu

404-727-9578

Sharese Windley

Role: CONTACT

sharese.windley@emory.edu

404-778-8778

Facility Contacts

Susan Modesitt, MD

Role: primary

smodesi@emory.edu

404-727-9578

Susan C. Modesitt

Role: primary

smodesi@emory.edu

404-727-9578

Susan Modesitt, MD

Role: primary

smodesi@emory.edu

404-727-9578

Other Identifiers

NCI-2024-03905

Identifier Type: REGISTRY

Identifier Source: secondary_id

STUDY00007242

Identifier Type: OTHER

Identifier Source: secondary_id

Winship6141-24

Identifier Type: OTHER

Identifier Source: secondary_id

P30CA138292

Identifier Type: NIH

Identifier Source: secondary_id

View Link

STUDY00007242

Identifier Type: -

Identifier Source: org_study_id