NCT06139458

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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
190

participants targeted

Target at P75+ for not_applicable

Timeline
13mo left

Started Jan 2024

Longer than P75 for not_applicable

Geographic Reach
1 country

2 active sites

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress68%
Jan 2024May 2027

First Submitted

Initial submission to the registry

November 15, 2023

Completed
3 days until next milestone

First Posted

Study publicly available on registry

November 18, 2023

Completed
2 months until next milestone

Study Start

First participant enrolled

January 18, 2024

Completed
3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 31, 2027

Expected
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 31, 2027

Last Updated

February 4, 2026

Status Verified

February 1, 2026

Enrollment Period

3 years

First QC Date

November 15, 2023

Last Update Submit

February 2, 2026

Conditions

Gynecologic CancerChemotherapy-induced Peripheral Neuropathy

Outcome Measures

Primary Outcomes (1)

  • Change in Functional Assessment of Cancer Therapy (FACT) -Taxane [FACT-NTX] (patient reported assessment) over time

    The FACT-NTX is a patient self-reported 11-item questionnaire used for evaluating symptoms and concerns specifically associated with chemotherapy induced neuropathy. The total score ranges from 0-44, and a lower FACT-NTX score corresponds to worsening neuropathy. For both the FACT-NTX and the sensory subscale of the FACT-NTX, a significant decrease in the score is defined as a decrease exceeding 10% from baseline.

    Up to two months after completion of chemotherapy, an average of 6 months

Secondary Outcomes (5)

  • Tolerability of cryocompression: scale

    Up to two months after completion of chemotherapy, an average of 6 months

  • Acceptability: scale

    Up to two months after completion of chemotherapy, an average of 6 months

  • Measure of manageability and acceptability for staff involved in the participants' care

    Up to two months after completion of chemotherapy, an average of 6 months

  • Change in Patient Neurotoxicity Questionnaire [PNQ] (patient reported assessment) over time

    Up to two months after completion of chemotherapy, an average of 6 months

  • Chemotherapy Dose

    Up to two months after completion of chemotherapy, an average of 6 months

Study Arms (2)

Cryotherapy

EXPERIMENTAL
Behavioral: Cryotherapy

Compression with Cryotherapy

EXPERIMENTAL
Behavioral: CryotherapyBehavioral: Compression

Interventions

CryotherapyBEHAVIORAL

Participants will receive cryotherapy on both hands and feet

Compression with CryotherapyCryotherapy
CompressionBEHAVIORAL

Participants will receive compression on both hands and feet

Compression with Cryotherapy

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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 the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Duke University Medical Center

Durham, North Carolina, 27710, United States

RECRUITING

Carilion Clinic

Roanoke, Virginia, 24016, United States

NOT YET RECRUITING

MeSH Terms

Interventions

Cryotherapy

Intervention Hierarchy (Ancestors)

Therapeutics

Study Officials

  • Laura Havrilesky

    DUHS

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Amelia Scott

CONTACT

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

Mary K Anastasio

CONTACT

225-603-7972mm765@duke.edu

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 15, 2023

First Posted

November 18, 2023

Study Start

January 18, 2024

Primary Completion (Estimated)

January 31, 2027

Study Completion (Estimated)

May 31, 2027

Last Updated

February 4, 2026

Record last verified: 2026-02

Data Sharing

IPD Sharing
Will not share

Locations

US(2)