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

NCT06492070 | Recruiting Phase 2 DMC FDA Drug

• 4 other identifiers: STUDY00007242NCI-2024-03905Winship6141-24P30CA138292
• Study Type: interventional
• Target: 70
• Locations: 1 country
• Sites: 3

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.

Conditions

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

Outcome Measures

Primary Outcomes (2)

• Difference in sensation and vibration objective neuropathy scores (Arms A and B)

  Specifically, the primary outcome will be the proportion of patients with abnormal vibration sensation times on at least one great toe or index finger assessed by a validated Neuropathy Assessment instrument. Will be compared between treatment groups (Arms A and B) using a chi-square test of independence.

  At 1 month post chemotherapy completion and at 6 months and 12 months

• Rates of impaired sensation and vibration on objective neuropathy testing and ≥ Grade 2 neuropathy among patients who recently completed paclitaxel treatment with standard of care treatment protocols (Arm C)

  The proportion of patients in Arm C will be tabulated with associated Clopper-Pearson 95% confidence intervals.

  At 1 month post chemotherapy completion and at 6 months and 12 months

Secondary Outcomes (6)

• Difference in sensation and vibration objective neuropathy scores

  At 1 month post chemotherapy completion and at 6 months and 12 months

• Difference in >= grade 2 neuropathy between the two study arms

  At 1 month post chemotherapy completion and at 6 months and 12 months

• Changes in Functional Assessment of Cancer Therapy/Gynecologic Oncology Group- Neurotoxicity (FACT/GOG-NTX) scores

  At 1 month post chemotherapy completion and at 6 months and 12 months

• Differences in the rate of patients starting new pharmacologic therapy for peripheral neuropathy while receiving paclitaxel chemotherapy

  At 1 month post chemotherapy completion and at 6 months and 12 months

• Differences in the rate of patients requiring paclitaxel dose reductions or chemotherapy delays due to peripheral neuropathy

  At 1 month post chemotherapy completion and at 6 months and 12 months

Study Arms (3)

Arm 2 (cryocompression)

EXPERIMENTAL

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.

Device: Cryocompression Therapy; Drug: Paclitaxel; Other: Quality-of-Life Assessment

Arm A (cryocompression and cilostazol)

EXPERIMENTAL

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.

Drug: Cilostazol; Device: Cryocompression Therapy; Drug: Paclitaxel; Other: Quality-of-Life Assessment

Arm C (standard of care)

ACTIVE COMPARATOR

Patients undergo standard of care throughout the study.

Other: Best Practice; Other: Quality-of-Life Assessment

Interventions

Best Practice OTHER

Undergo standard of care

Also known as: standard of care, standard therapy

Arm C (standard of care)

Cilostazol DRUG

Given PO

Also known as: Pletal

Arm A (cryocompression and cilostazol)

Cryocompression Therapy DEVICE

Undergo cryocompression therapy

Arm 2 (cryocompression); Arm A (cryocompression and cilostazol)

Paclitaxel DRUG

Given by infusion

Also known as: Anzatax, Asotax, Bristaxol, Praxel, Taxol, Taxol Konzentrat

Arm 2 (cryocompression); Arm A (cryocompression and cilostazol)

Quality-of-Life Assessment OTHER

Ancillary studies

Also known as: Quality of Life Assessment

Arm 2 (cryocompression); Arm A (cryocompression and cilostazol); Arm C (standard of care)

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Emory University: lead
• National Cancer Institute (NCI): collaborator

Study Sites (3)

Emory University Hospital Midtown

Atlanta, Georgia, 30308, United States

RECRUITING

Emory University Hospital/Winship Cancer Institute

Atlanta, Georgia, 30322, United States

NOT YET RECRUITING

Emory Saint Joseph's Hospital

Atlanta, Georgia, 30342, United States

NOT YET RECRUITING

MeSH Terms

Conditions

Uterine Cervical Neoplasms; Fallopian Tube Neoplasms; Uterine Neoplasms; Ovarian Neoplasms; Vulvar Neoplasms

Interventions

Practice Guidelines as Topic; Standard of Care; Cilostazol; Paclitaxel; Taxes

Condition Hierarchy (Ancestors)

Genital Neoplasms, Female; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Uterine Cervical Diseases; Uterine Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases; Fallopian Tube Diseases; Adnexal Diseases; Endocrine Gland Neoplasms; Ovarian Diseases; Endocrine System Diseases; Gonadal Disorders; Vulvar Diseases

Intervention Hierarchy (Ancestors)

Guidelines as Topic; Quality Assurance, Health Care; Quality of Health Care; Health Services Administration; Health Care Quality, Access, and Evaluation; Quality Indicators, Health Care; Tetrazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Quinolines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Taxoids; Cyclodecanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Diterpenes; Terpenes; Economics; Health Care Economics and Organizations

Study Officials

• Susan C Modesitt

  Emory University Hospital/Winship Cancer Institute

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Susan Modesitt, MD

CONTACT

404-727-9578; smodesi@emory.edu

Sharese Windley

CONTACT

404-778-8778; sharese.windley@emory.edu

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: June 21, 2024
• First Posted: July 9, 2024
• Study Start: August 1, 2024
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): December 31, 2027
• Last Updated: August 27, 2025

Record last verified: 2025-08

Locations

US (3)