Using cryocompression to reduce nerve pain from chemotherapy in gynecologic cancer patients
Use of Cryocompression to Reduce Chemotherapy-induced Peripheral Neuropathy in Gynecologic Cancer: a Randomized Controlled Trial - COHORT 2
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
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 190 (estimated) |
| Ages | 18 Years and up |
| Sex | Female |
| Sponsor | Duke University Academic / other |
| Drugs / interventions | chemotherapy |
| Locations | 2 sites (Durham, North Carolina and 1 other locations) |
| Trial ID | NCT06139458 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates include patients diagnosed with gynecologic cancers who are scheduled to receive at least six cycles of paclitaxel chemotherapy.
Not a fit: Patients with a history of neurotoxic chemotherapy or pre-existing peripheral neuropathy conditions may not benefit from this study.
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 performed: While similar approaches have been explored, this specific combination of cryotherapy and compression therapy in this patient population is novel.
Eligibility criteria
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 this trial is running
Durham, North Carolina and 1 other locations
- Duke University Medical Center — Durham, North Carolina, United States (Recruiting)
- Carilion Clinic — Roanoke, Virginia, United States (Not_yet_recruiting)
Study contacts
- Principal investigator: Laura Havrilesky — Duhs
- Study coordinator: Amelia Scott
- Email: amelia.lorenzo@duke.edu
- Phone: 919-613-4584
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.