Using cryocompression to reduce nerve pain from chemotherapy in gynecologic cancer patients
Official title: Use of Cryocompression to Reduce Chemotherapy-induced Peripheral Neuropathy in Gynecologic Cancer: a Randomized Controlled Trial - COHORT 2
Run by Duke University · NCT06139458 · Data updated 2026-11-12
This study is testing if using cold therapy with compression can help reduce nerve pain from chemotherapy in women with gynecologic cancer better than just cold therapy alone.
Quick facts
| Study type | Interventional |
|---|---|
| Ages | 18 Years and up |
| Sex | Women only |
| Enrollment | 190 (estimated) |
| Sponsor | Duke University Academic / other |
| Drugs / interventions | chemotherapy |
| Locations | 4 sites (Hartford, Connecticut and 3 other locations) |
| Status | Recruiting |
| Started | January 18, 2024 |
| Main results expected | January 31, 2027 |
| Study ends | May 31, 2027 |
| Registry record updated | October 5, 2026 |
| Trial ID | NCT06139458 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates include patients diagnosed with gynecologic cancers who are scheduled to receive at least six cycles of paclitaxel chemotherapy.
✕Probably not a fit
Patients with a history of neurotoxic chemotherapy or pre-existing peripheral neuropathy conditions may not benefit from this study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This study investigates the effectiveness of combining cryotherapy wraps with compression therapy, known as cryocompression, compared to cryotherapy wraps alone in reducing chemotherapy-induced peripheral neuropathy in patients with gynecologic cancer. Participants will be randomly assigned to receive either treatment during their taxane infusions and will complete various surveys to assess neuropathy symptoms, tolerability, and staff satisfaction. The study aims to determine if cryocompression is at least as effective as cryotherapy alone in managing neuropathy symptoms. Adverse events will be monitored throughout the trial.
Why it matters
Potential benefit: If successful, this approach could significantly alleviate nerve pain for patients undergoing chemotherapy for gynecologic cancers.
How similar studies have gone: While similar approaches have been explored, this specific combination of cryotherapy and compression therapy in this patient population is novel.
Who can join: the full rules
Show full inclusion / exclusion 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.
Where it's running
-
Hartford Healthcare Cancer Institute
Hartford, Connecticut, United States Recruiting -
Middlesex Health Cancer Center - Middletown
Middletown, Connecticut, United States Recruiting -
Duke University Medical Center
Durham, North Carolina, United States Recruiting -
Carilion Clinic
Roanoke, Virginia, United States Recruiting
Study contacts
- Principal investigator: Laura Havrilesky — Duhs
- Study coordinator: Amelia Scott
- Email: amelia.lorenzo@duke.edu
- Phone: 919-613-4584
Similar studies
Other studies for the same condition or treatment. Recruiting studies are listed first.
-
NMTCuff vs standard TOF monitoring during gynecologic oncology surgery
This study tests whether NMTCuff monitoring can better detect neuromuscular recovery than standard TOF monitoring in women undergoing laparoscopic gynecologic cancer surgery.
-
Radiotherapy for gynecologic cancer with up to 10 metastatic sites
This registry follows adults with gynecologic cancer who have 1 to 10 active metastatic lesions and are treated with radiotherapy as part of routine care to see how such treatments work in real-world settings.
-
Cryotherapy during weekly paclitaxel to reduce chemotherapy-induced numbness and tingling
This study tests whether applying cryotherapy to hands and feet during weekly paclitaxel helps prevent CIPN in women with breast cancer.
-
Personalized supervised exercise program for adults with breast or gynecologic cancer
A small pilot study will test a supervised, personalized exercise program to see if it is safe, feasible, and acceptable for adults with a history of breast or gynecologic cancer.
-
SIR2501 plus Paclitaxel for solid tumors
This Phase 2 study tests SIR2501 in adults with solid tumors who are starting paclitaxel chemotherapy to see if it is safe and tolerable and to explore its effect on chemotherapy-induced neuropathy.
-
Non-invasive brain stimulation to help chemotherapy-induced nerve problems in cancer survivors
This trial tests whether a gentle brain stimulation method (tDCS) can help reduce numbness, tingling, and pain from CIPN in cancer survivors who are not currently in treatment.
How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.