Cryocompression to Reduce Chemotherapy-induced Peripheral Neuropathy in Gynecologic Cancer - COHORT 2

Use of Cryocompression to Reduce Chemotherapy-induced Peripheral Neuropathy in Gynecologic Cancer: a Randomized Controlled Trial - COHORT 2

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.

Study Overview

• Status: Recruiting
• Conditions: Gynecologic Cancer; Chemotherapy-induced Peripheral Neuropathy
• Intervention / Treatment: Behavioral: Cryotherapy; Behavioral: Compression

Detailed Description

Participants will be randomized by patient to receive cryotherapy wraps plus compression therapy (cryocompression) versus cryotherapy wraps alone applied to the bilateral hands and feet. Participants will receive cryotherapy (+/- compression) for the duration of their taxane infusions. Participants will be asked to complete the FACT-NTX survey and a PNQ neuropathy surveys at each infusion visit to evaluate symptoms related to neuropathy. Participants will also complete a brief acceptability and tolerability survey at each visit. Lastly, a staff satisfaction survey will be administered at each visit as well. The investigators will test the hypothesis that the average final visit FACT-NTX11 scores in the cryotherapy group are noninferior to the cryocompression group with a noninferiority margin of 2.5 points. The investigators will routinely monitor for the following adverse events: frost bite, (unexpected) hospitalizations, and death.

• Study Type: Interventional
• Enrollment (Estimated): 190
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Amelia Scott; Phone Number: 919-613-4584; Email: amelia.lorenzo@duke.edu
• Study Contact Backup: Name: Mary K Anastasio; Phone Number: 225-603-7972; Email: mm765@duke.edu

Study Locations

• United States
  • Connecticut
    • Hartford, Connecticut, United States, 06106
      • Not yet recruiting
      • Hartford HealthCare Cancer Institute
      • Principal Investigator: Amy Brown, MD
      • Contact: Corey Glider; Phone Number: 860-972-5019; Email: Corey.Glider@hhchealth.org
    • Middletown, Connecticut, United States, 06457
      • Recruiting
      • Middlesex Health Cancer Center - Middletown
      • Contact: Loriann MacLean, MSN; Phone Number: 860-358-2015; Email: loriann.maclean@midhosp.org
      • Principal Investigator: Karthikeyan Kandevelou, MD
  • North Carolina
    • Durham, North Carolina, United States, 27710
      • Recruiting
      • Duke University Medical Center
      • Contact: Laura Havrilesky, MD; Phone Number: 919-684-0126; Email: laura.havrilesky@duke.edu
      • Principal Investigator: Laura Havrilesky, MD
  • Virginia
    • Roanoke, Virginia, United States, 24016
      • Recruiting
      • Carilion Clinic
      • Contact: Danielle Mitchell; Phone Number: 540-521-1355; Email: dmmitchell@carilionclinic.org
      • Contact: Erin Saks, MD; Phone Number: (540) 581-0160; Email: ejsaks@carilionclinic.org
      • Principal Investigator: Erin Saks, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Cryotherapy	Behavioral: Cryotherapy; Participants will receive cryotherapy on both hands and feet
Experimental: Compression with Cryotherapy	Behavioral: Cryotherapy; Participants will receive cryotherapy on both hands and feet; Behavioral: Compression; Participants will receive compression on both hands and feet

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Tolerability of cryocompression: scale	Subjects will be asked to complete a cryocompression tolerability assessment after each chemotherapy session in which they will answer the question, "How tolerable was the cryocompression procedure for you?" on a scale from 0 to 100. A score of 0 means "not tolerable at all" and a score of 100 is "very tolerable". Pain, abnormal sensation, and adherence to cryocompression will also be evaluated as patient-reported measures of tolerability.	Up to two months after completion of chemotherapy, an average of 6 months
Acceptability: scale	Subjects will be asked to complete a cryocompression acceptability assessment after each chemotherapy session in which they answer the questions, "How acceptable was the cryocompression procedure to you?" and "How likely are you to continue with cryocompression at your next chemotherapy treatment?" on a scale from 0 to 100, with 0 being "not acceptable, not likely to continue" and 100 being "very acceptable, very likely to continue".	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	Staff will be asked to complete an acceptability assessment after each chemotherapy session in which they will answer the question, "How manageable or acceptable was this patient's cryotherapy/cryocompression therapy to you in working with a patient receiving chemotherapy?" on a scale from 0 to 100. A score of 0 means "not at all acceptable" and a score of 100 is "complete acceptable". They will also be asked "In your experience, compare the ease of use of the cryotherapy wrap versus plastic ice bags" on a scale from 0 to 100. A score of 0 means "cryotherapy wraps are much harder," and a score of 100 means "cryotherapy wraps are much easier."	Up to two months after completion of chemotherapy, an average of 6 months
Change in Patient Neurotoxicity Questionnaire [PNQ] (patient reported assessment) over time	PNQ is a patient-reported questionnaire that consists of 2 items, representing motor and sensory components, with increasing grades for worsening symptoms. Patients will respond to each question for each of their 4 extremities by grading sensory and motor symptoms as A (no neuropathy), B (mild neuropathy), C (moderate neuropathy that does not interfere with activities of daily living [ADL]), D (moderate neuropathy that does interfere with ADL), or E (severe neuropathy that interferes with ADL).	Up to two months after completion of chemotherapy, an average of 6 months
Chemotherapy Dose	Study staff will record the taxol dose at each cycle	Up to two months after completion of chemotherapy, an average of 6 months

Collaborators and Investigators

• Sponsor: Duke University
• Investigators: Principal Investigator: Laura Havrilesky, DUHS

Study record dates

Study Major Dates

• Study Start (Actual): January 18, 2024
• Primary Completion (Estimated): January 31, 2027
• Study Completion (Estimated): May 31, 2027

Study Registration Dates

• First Submitted: November 15, 2023
• First Submitted That Met QC Criteria: November 15, 2023
• First Posted (Actual): November 18, 2023

Study Record Updates

• Last Update Posted (Actual): June 2, 2026
• Last Update Submitted That Met QC Criteria: June 1, 2026
• Last Verified: June 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Nervous System Diseases; Neuromuscular Diseases; Peripheral Nervous System Diseases; Therapeutics; Cryotherapy
• Other Study ID Numbers: Pro00106236_1

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No