NCT07064798 · Dana-Farber Cancer Institute
Cryocompression for CIPN
What this study is about
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 treatment group$1 and legs (limbs) resulting in possible numbness, pain, and/or loss of motor function, that may occur as a result of taxane-based chemotherapy.
View original scientific description
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.
Interventions
DEVICE
Paxman Limb Cryocompression System
An investigational device designed to provide controlled cooling and compression to participant limbs during chemotherapy administration. The device is comprised of a control unit, connecting hose, and two limb wraps. The customizable limb wraps delivers continuous-flow cooling-and-compression to participant extremities
Primary outcome measures
Change in Patient-Reported CIPN Symptoms Assessed by the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire-Chemotherapy-Induced Peripheral Neuropathy module at End of Treatment
Time frame: Assessed 1-4 weeks after the final taxane infusion (end of treatment).
Chemotherapy-induced peripheral neuropathy (CIPN) will be assessed using the validated European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire-Chemotherapy-Induced Peripheral Neuropathy module (EORTC QLQ-CIPN20). This aim is defined as evaluating the incidence and severity of subjectively reported CIPN symptoms, including numbness, tingling, and pain in hands and feet. Clinically significant CIPN is expected to emerge during taxane-based treatment and will be captured at the follow-up visit post-treatment.
Duration of Cryocompression Tolerated During Neurotoxic Chemotherapy
Time frame: Up to 12 weeks
Tolerance of cryocompression will be defined by the total amount of time (in minutes) the participant is able to wear cryocompression devices during chemotherapy infusions. This aim evaluates feasibility and tolerability from the patient perspective, based on self-reported ability to continue cryocompression throughout the infusion. Early removal or shortened wear time due to discomfort will be recorded.
Incidence of Core Temperature Decrease >1°F and Skin Intolerance Symptoms Associated with Cryocompression
Time frame: Throughout each chemotherapy infusion visit when cryocompression is applied. Up to 12 weeks
This aim assesses the physiological safety of cryocompression. Core body temperature will be monitored orally before, during, and after cryocompression application, with any decreases greater than 1°F considered significant. Skin will be evaluated for intolerance signs (e.g., white or greyish-yellow discoloration, pain, tingling, numbness, or pressure) on cryocompressed limbs. The aim is defined as the absence of these adverse effects during cryocompression use.
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
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
Where
- Boston, Massachusetts
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Apr 15, 2026 · Source of record for eligibility and locations