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New treatment option for Chemotherapy-induced Peripheral Neuropathy
Official title Cryocompression for CIPN
ClinicalTrials.gov ID: NCT07064798
What this study is testing
- What it's testing
- 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)
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- 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)
You likely can't join if
- Previous exposure to neurotoxic chemotherapy
- Pre-existing neuropathy
- History of Raynaud's phenomenon, cold agglutinin disease, cryoglobulinemia, cryofibrinogenemia, post-traumatic cold dystrophy, peripheral arterial...
- 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
See the full eligibility 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
- 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
The study team makes the final eligibility decision.
Where it's taking place
- Boston, Massachusetts, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Boston, Massachusetts, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.