RECRUITING

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

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

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

Quick Facts

Study Start:2024-08-01
Study Completion:2027-12-31
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT06492070

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:FEMALE
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * INCLUSION CRITERIA FOR ARMS A and B:
  2. * Age 18 years or older
  3. * 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
  4. * Eastern Cooperative Oncology Group performance status from 0 to 2
  5. * ARM C: Age 18 years or older
  6. * 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
  7. * ARM C: Eastern Cooperative Oncology Group performance status from 0 to 2
  1. * EXCLUSION CRITERIA FOR ARMS A and B:
  2. * Any patient unable and/or unwilling to cooperate with all study protocols
  3. * Previous treatment with paclitaxel
  4. * Patients with baseline pre-chemotherapy neuropathy requiring pharmacologic treatment
  5. * Diabetes mellitus with hemoglobin A1c \>7.0
  6. * Hepatic impairment, moderate to severe (Class B \& C by Child-Pugh score)
  7. * Slight or moderate malignant ascites alone will not be considered indicative of hepatic impairment in the absence of other evidence of hepatic disease
  8. * Raynaud's phenomenon
  9. * Active wounds on the hands or feet
  10. * High risk uncontrolled arrhythmias
  11. * Ischemic heart disease
  12. * Inadequate bone marrow function with white blood count \< 4,000/mm\^3 and platelet count \< 100,000/mm\^3
  13. * Inadequate liver function with serum total bilirubin \>= 1.5mg/dL
  14. * Inadequate renal function with serum creatinine \>= 1.5mg/dL
  15. * On one or more antiplatelet therapies excluding acetylsalicylic acid
  16. * Hypersensitivity (e.g. anaphylaxis, angioedema) to cilostazol or any components of cilostazol
  17. * Pregnant and nursing patients
  18. * 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
  19. * Incarcerated patients
  20. * Patients unable to consent for themselves, due to cognitive impairment or other reason
  21. * Patients with contraindications to cilostazol
  22. * Any patient who does not meet criteria to receive chemotherapy
  23. * ARM C: Any patient unable and/or unwilling to cooperate with all study protocols
  24. * ARM C: Previous treatment with paclitaxel
  25. * ARM C: Patients with baseline pre-chemotherapy neuropathy requiring pharmacologic treatment
  26. * ARM C: Diabetes mellitus with hemoglobin A1c \>7.0
  27. * ARM C: Pregnant patients
  28. * ARM C: Incarcerated patients
  29. * ARM C: Patients unable to consent for themselves, due to cognitive impairment or other reason

Contacts and Locations

Study Contact

Susan Modesitt, MD
CONTACT
404-727-9578
smodesi@emory.edu
Sharese Windley
CONTACT
404-778-8778
sharese.windley@emory.edu

Principal Investigator

Susan C Modesitt
PRINCIPAL_INVESTIGATOR
Emory University Hospital/Winship Cancer Institute

Study Locations (Sites)

Emory University Hospital Midtown
Atlanta, Georgia, 30308
United States
Emory University Hospital/Winship Cancer Institute
Atlanta, Georgia, 30322
United States
Emory Saint Joseph's Hospital
Atlanta, Georgia, 30342
United States

Collaborators and Investigators

Sponsor: Emory University

  • Susan C Modesitt, PRINCIPAL_INVESTIGATOR, Emory University Hospital/Winship Cancer Institute

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2024-08-01
Study Completion Date2027-12-31

Study Record Updates

Study Start Date2024-08-01
Study Completion Date2027-12-31

Terms related to this study

Additional Relevant MeSH Terms

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