Dana-Farber Cancer Institute
Boston, Massachusetts, 02215, United States
Location status: Recruiting
Location contact
Theresa Jabaley Leonarczyk, PhD, RN
PRINCIPAL_INVESTIGATOR
Theresa Leonarczyk, PhD
CONTACT
Theresa Leonarczyk, PhD, RN
CONTACT
Recruiting
NCT Number: NCT07064798
Cryocompression for CIPN
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)
Recruiting
Interested in participating?
Request InfoKey information
Conditions
Age range
18 year and older
Sex eligibility
All sexes
Study type
Interventional
Phase
Not applicable
Primary location
About this study
This randomized controlled trial 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. There is evidence that cooling therapy may be effective for preventing peripheral neuropathy caused by taxane-based chemotherapy.
The U.S. Food and Drug Administration (FDA) has not approved the PAXMAN Limb Cryocompression System as a treatment to reduce peripheral neuropathy.
Participants will be randomized into 1 of 2 groups: Arm A: Cryocompression + Standard of Care Taxane-Based Chemotherapy versus Arm B: Standard of Care Taxane-Based Chemotherapy. Participants will be randomized in a 2:1 manner, meaning a participant is 2 times the chance (approximately 67%) of being in Arm A than in Arm B (approximately 33%). Randomization means a participant is placed into a study group by chance.
The research study procedures include screening for eligibility, in-clinic visits, and questionnaires.
It is expected that about 50 people will take part in this research study.
Paxman Coolers, Inc. is providing the Paxman Limb Cryocompression Systems for this study.
Who can participate
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
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
Treatment and study plan
Paxman Limb Cryocompression System
DeviceAn 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
Other names: PLCS
Primary outcomes
-
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.
Study contacts
Contact information is provided by the study sponsor or research team.
Jabaley Leonarczyk, PhD, RN
CONTACT
Theresa Jabaley Leonarczyk, PhD, RN
CONTACT
Sponsors and collaborators
Lead sponsor
Dana-Farber Cancer Institute
Other
Registry information
Official study title
Evaluating the Use of Limb Cryocompression to Reduce Taxane-induced Peripheral Neuropathy
Important dates
- Study start
- 2025
- Primary completion
- 2027
- Study completion
- 2027
- First posted
- Jul 15, 2025
- Registry last updated
- Apr 15, 2026
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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