| NCT ID | NCT07064798 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Dana-Farber Cancer Institute |
| Condition | Chemotherapy-induced Peripheral Neuropathy |
| Study Type | INTERVENTIONAL |
| Enrollment | 50 participants |
| Start Date | 2025-10-22 |
| Primary Completion | 2027-08 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 50 participants in total. It began in 2025-10-22 with a primary completion date of 2027-08.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
This study aims to evaluate the effectiveness, tolerability, and safety of using cooling therapy and pressure (cryocompression) to reduce peripheral neuropathy, a condition affecting the nerves supplying the arms and legs (limbs) resulting in possible numbness, pain, and/or loss of motor function, that may occur as a result of taxane-based chemotherapy. The name of the device used in this research study is: -Paxman Limb Cryocompression System (PLCS)
Eligibility Criteria
Inclusion Criteria: * Adults \> 18 years of age * Gynecologic or breast malignancy * Starting 1st cycle of treatment with chemotherapy regimens: * Weekly paclitaxel x 12 or weekly paclitaxel/carboplatin x 12, Q2 weeks paclitaxel X4 (preceded by doxorubicin/cyclophosphamide). (Breast Oncology) * Q3 weeks paclitaxel/carboplatin X 6-8 (GYN) * Receiving treatment on the main campus of DFCI (these patients are currently seen on Yawkey 9 and 10 and at Chestnut Hill) * Able to complete questionnaires in English or Spanish Exclusion Criteria: * Previous exposure to neurotoxic chemotherapy * Pre-existing neuropathy * History of Raynaud's phenomenon, cold agglutinin disease, cryoglobulinemia, cryofibrinogenemia, post-traumatic cold dystrophy, peripheral arterial ischemia, or sickle cell disease * Undergoing desensitization * Lymphedema in the limb where the device would be applied * Open skin wounds or ulcers of the limbs where the device would be applied
Contact & Investigator
Theresa Jabaley Leonarczyk, PhD, RN
PRINCIPAL INVESTIGATOR
Dana-Farber Cancer Institute
Frequently Asked Questions
Who can join the NCT07064798 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Chemotherapy-induced Peripheral Neuropathy. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07064798 currently recruiting?
Yes, NCT07064798 is actively recruiting participants. Contact the research team at theresa_jabaley@dfci.harvard.edu for enrollment information.
Where is the NCT07064798 trial being conducted?
This trial is being conducted at Boston, United States.
Who is sponsoring the NCT07064798 clinical trial?
NCT07064798 is sponsored by Dana-Farber Cancer Institute. The principal investigator is Theresa Jabaley Leonarczyk, PhD, RN at Dana-Farber Cancer Institute. The trial plans to enroll 50 participants.