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Official Title

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

Phase
Phase 2
Sponsor
Emory University
Enrollment
70
Timeline
Aug 2024 → Dec 2027
About This Study

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 Criteria

Inclusion Criteria

  • 1Age 18 years or older
  • 2Diagnosis 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
  • 3Eastern Cooperative Oncology Group performance status from 0 to 2
  • 4ARM C: Age 18 years or older
  • 5ARM 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
  • 6ARM C: Eastern Cooperative Oncology Group performance status from 0 to 2

Exclusion Criteria

  • 1Any patient unable and/or unwilling to cooperate with all study protocols
  • 2Previous treatment with paclitaxel
  • 3Patients with baseline pre-chemotherapy neuropathy requiring pharmacologic treatment
  • 4Diabetes mellitus with hemoglobin A1c \>7.0
  • 5Hepatic impairment, moderate to severe (Class B \& C by Child-Pugh score)
  • 6Slight or moderate malignant ascites alone will not be considered indicative of hepatic impairment in the absence of other evidence of hepatic disease
  • 7Raynaud's phenomenon
  • 8Active wounds on the hands or feet
  • 9High risk uncontrolled arrhythmias
  • 10Ischemic heart disease
  • 11Inadequate bone marrow function with white blood count \< 4,000/mm\^3 and platelet count \< 100,000/mm\^3
  • 12Inadequate liver function with serum total bilirubin \>= 1.5mg/dL
  • 13Inadequate renal function with serum creatinine \>= 1.5mg/dL
  • 14On one or more antiplatelet therapies excluding acetylsalicylic acid
  • 15Hypersensitivity (e.g. anaphylaxis, angioedema) to cilostazol or any components of cilostazol
  • 16Pregnant and nursing patients
  • 17Patients 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
  • 18Incarcerated patients
  • 19Patients unable to consent for themselves, due to cognitive impairment or other reason
  • 20Patients with contraindications to cilostazol
  • 21Any patient who does not meet criteria to receive chemotherapy
  • 22ARM C: Any patient unable and/or unwilling to cooperate with all study protocols
  • 23ARM C: Previous treatment with paclitaxel
  • 24ARM C: Patients with baseline pre-chemotherapy neuropathy requiring pharmacologic treatment
  • 25ARM C: Diabetes mellitus with hemoglobin A1c \>7.0
  • 26ARM C: Pregnant patients
  • 27ARM C: Incarcerated patients
  • 28ARM C: Patients unable to consent for themselves, due to cognitive impairment or other reason

Locations

3 sites participating in this study

Emory University Hospital Midtown

Atlanta, Georgia 30308

Recruiting

Emory University Hospital/Winship Cancer Institute

Atlanta, Georgia 30322

Recruiting

Susan C. Modesitt

Emory Saint Joseph's Hospital

Atlanta, Georgia 30342

Recruiting
Data sourced from ClinicalTrials.govView on ClinicalTrials.gov →