NCT06139458 Cryocompression to Reduce Chemotherapy-induced Peripheral Neuropathy in Gynecologic Cancer - COHORT 2
| NCT ID | NCT06139458 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Duke University |
| Condition | Gynecologic Cancer |
| Study Type | INTERVENTIONAL |
| Enrollment | 190 participants |
| Start Date | 2024-01-18 |
| Primary Completion | 2027-01-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 190 participants in total. It began in 2024-01-18 with a primary completion date of 2027-01-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
The investigators aim to determine the effect of cryotherapy wraps plus compression therapy (henceforth referred to as cryocompression) versus cryotherapy wraps alone on the incidence and degree of chemotherapy-induced peripheral neuropathy in patients with gynecologic cancer using a noninferiority design. The investigators also aim to determine the effect of cryocompression versus cryotherapy on patient tolerability and patient and staff satisfaction.
Eligibility Criteria
Inclusion Criteria: * Gynecologic cancer diagnosis (ovarian, cervical, endometrial cancer; adenocarcinomas of likely primary gynecologic origin based on cytology or FNA in conjunction with radiologic impression will be eligible) * Plan to receive at least 6 cycles of paclitaxel administered every 3 weeks at the Duke Cancer Center or Macon Pond or at the Carilion Clinic in Roanoke, VA. Patients receiving neoadjuvant chemotherapy with a plan for interval debulking will be eligible. * ECOG (Eastern Cooperative Oncology Group) performance status of 0-1 Exclusion Criteria: * Treated with prior neurotoxic chemotherapeutic agents * Baseline diagnosis of peripheral neuropathy such as diabetic neuropathy, or conditions including but not limited to fibromyalgia, cryoglobulinemia and Raynaud's disease.
Contact & Investigator
Laura Havrilesky
PRINCIPAL INVESTIGATOR
DUHS
Frequently Asked Questions
Who can join the NCT06139458 clinical trial?
This trial is open to female participants only, aged 18 Years or older, studying Gynecologic Cancer. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06139458 currently recruiting?
Yes, NCT06139458 is actively recruiting participants. Contact the research team at amelia.lorenzo@duke.edu for enrollment information.
Where is the NCT06139458 trial being conducted?
This trial is being conducted at Hartford, United States, Middletown, United States, Durham, United States, Roanoke, United States.
Who is sponsoring the NCT06139458 clinical trial?
NCT06139458 is sponsored by Duke University. The principal investigator is Laura Havrilesky at DUHS. The trial plans to enroll 190 participants.
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