Study on Cryocompression With or Without Cilostazol to Prevent Nerve Damage from Paclitaxel in Patients with Gynecological Cancers

Sponsor: Emory University

Sponsor score: 40
Inactive

ClinicalTrials ID:NCT06492070

Provider View

This clinical trial is testing whether using cryocompression therapy, with or without the drug cilostazol, can help prevent nerve damage caused by the chemotherapy drug paclitaxel in patients with gynecological cancers.

Patient Parameters

Program Overview

The study aims to find out if cryocompression therapy, alone or combined with cilostazol, can prevent nerve damage (numbness, pain, or tingling in hands and feet) caused by the chemotherapy drug paclitaxel in patients with gynecological cancers. Cryocompression involves using cooling wraps on the body, while cilostazol is a medication that improves blood flow. The study will assess if this combination is safe and effective in reducing nerve damage.

Description

The study is divided into three groups:

  • Group A: Patients receive paclitaxel chemotherapy and use cryocompression therapy with cooling wraps three times a day during their treatment. They also take cilostazol pills twice a day, starting with their first chemotherapy session and continuing for two weeks after their last session. Treatment lasts for 6-9 cycles unless the cancer progresses or side effects become too severe.

  • Group B: Patients receive paclitaxel chemotherapy and use cryocompression therapy with cooling wraps three times a day during their treatment. Treatment lasts for 6-9 cycles unless the cancer progresses or side effects become too severe.

  • Group C: Patients receive standard care as determined by their doctor.

After completing the study treatment, patients will have follow-up visits 30 days later and then up to one year to monitor their health and any side effects.

Eligibility Criteria

Inclusion Criteria

  • For Groups A and B:

    • Age 18 years or older
    • Diagnosed with uterine, ovarian, fallopian tube, primary peritoneal, cervical, or vulvar cancer
    • Planned to receive 6-9 cycles of chemotherapy with paclitaxel and carboplatin or cisplatin, possibly with additional treatments
    • Good overall health with a performance status score of 0 to 2

  • For Group C:

    • Age 18 years or older
    • Diagnosed with the same types of cancer and completed 6-9 cycles of chemotherapy within the last 3 months
    • Good overall health with a performance status score of 0 to 2

Exclusion Criteria

  • For Groups A and B:

    • Unable or unwilling to follow study protocols
    • Previous treatment with paclitaxel
    • Existing nerve damage requiring medication
    • Diabetes with high blood sugar levels
    • Moderate to severe liver problems
    • Raynaud's phenomenon or active wounds on hands or feet
    • Heart rhythm problems or heart disease
    • Low blood cell counts or poor liver or kidney function
    • Taking certain blood-thinning medications
    • Allergic to cilostazol
    • Pregnant or nursing
    • Incarcerated or unable to consent
    • Not eligible for chemotherapy

  • For Group C:

    • Same criteria as above, including previous treatment with paclitaxel and existing nerve damage requiring medication
    • Pregnant or incarcerated
    • Unable to consent

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