Using cryocompression and cilostazol to prevent nerve damage from chemotherapy in women with gynecological cancers

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This phase II trial evaluates the effectiveness of cryocompression therapy, both alone and in combination with cilostazol, to prevent peripheral neuropathy caused by paclitaxel in women with gynecological cancers. The study involves three arms: one receiving paclitaxel with cryocompression and cilostazol, another receiving paclitaxel with cryocompression alone, and a third group receiving standard care to assess baseline neuropathy rates. The trial aims to quantify the incidence and severity of neuropathy and evaluate the impact of cilostazol on quality of life and the need for symptom management. Safety assessments will also be conducted regarding the use of cilostazol alongside various chemotherapy regimens.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* INCLUSION CRITERIA FOR ARMS A and B:
* 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:

* EXCLUSION CRITERIA FOR ARMS A and B:
* 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

Where it's running

• Emory University Hospital Midtown
  Atlanta, Georgia, United States Recruiting
• Emory University Hospital/Winship Cancer Institute
  Atlanta, Georgia, United States Not yet recruiting
• Emory Saint Joseph's Hospital
  Atlanta, Georgia, United States Not yet recruiting

Study contacts

• Principal investigator: Susan C Modesitt — Emory University Hospital/Winship Cancer Institute
• Study coordinator: Susan Modesitt, MD
• Email: smodesi@emory.edu
• Phone: 404-727-9578

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.