Recruiting

Cryocompression

Sponsor:

Duke University

Code:

NCT06139458

Conditions

Gynecologic Cancer

Chemotherapy-induced Peripheral Neuropathy

Eligibility Criteria

Sex: Female

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Cryotherapy

Compression

Study Details

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.

Conditions

Gynecologic Cancer

Chemotherapy-induced Peripheral Neuropathy

Study ID

NCT06139458

Start date

Jan 18, 2024

Status verified date

Jun, 2026

Completion date

May 31, 2027

Anticipated

Primary completion date

Jan 31, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: Female

Age: 18+

Healthy Volunteers: Not accepted

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.

Study Design

Enrollment

190 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Prevention

Interventions and Outcome Measures

Arms

experimental: Cryotherapy

experimental: Compression with Cryotherapy

Interventions

Cryotherapy

Participants will receive cryotherapy on both hands and feet

Compression

Participants will receive compression on both hands and feet

Primary outcome measure

  • Change in Functional Assessment of Cancer Therapy (FACT) -Taxane [FACT-NTX] (patient reported assessment) over time [ Time Frame: Up to two months after completion of chemotherapy, an average of 6 months ]

Central Contacts and Locations

Central contacts

Amelia Scott

919-613-4584amelia.lorenzo@duke.edu

Mary K Anastasio

225-603-7972mm765@duke.edu

Locations

Middlesex Health Cancer Center - Middletown

Recruiting

Middletown, Connecticut, United States, 06457

Contacts

Loriann MacLean, MSN

860-358-2015loriann.maclean@midhosp.org

Principal Investigator:

Karthikeyan Kandevelou, MD

Duke University Medical Center

Recruiting

Durham, North Carolina, United States, 27710

Contacts

Laura Havrilesky, MD

919-684-0126laura.havrilesky@duke.edu

Principal Investigator:

Laura Havrilesky, MD

Carilion Clinic

Recruiting

Roanoke, Virginia, United States, 24016

Contacts

Danielle Mitchell

540-521-1355dmmitchell@carilionclinic.org

Erin Saks, MD

(540) 581-0160ejsaks@carilionclinic.org

Principal Investigator:

Erin Saks, MD

More Information

Sponsor

Duke University

Last update posted

Jun 2, 2026

Last verified

Jun, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Duke University on 2026-06-02.