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Ice Compress: Randomized Trial of Limb Cryocompression Versus Continuous Compression Versus Low Cyclic Compression for the Prevention of Taxane-Induced Peripheral Neuropathy
This phase III trial compares the effect of 3 study approaches in preventing chemotherapy-induced peripheral neuropathy: 1) cryocompression, 2) continuous compression, and 3) low cyclic compression. Taxane chemotherapy drugs, such as paclitaxel or docetaxel, can cause a nerve disorder called peripheral neuropathy, which can cause numbness, tingling, or pain in the arms and legs. The 3 study approaches will use a device, called the Paxman Limb Cryocompression System, made of wraps that cool and/or compress the arms and legs. This study may help researchers determine if any of the study approaches are able to prevent taxane chemotherapy from causing peripheral neuropathy.
Eligibility Criteria
Inclusion Criteria
- 1Participants must have a diagnosis of a solid tumor malignancy.
- 2Participants must be planning to begin neoadjuvant or adjuvant therapy with one of the protocol-specified chemotherapy regimens below for a solid tumor malignancy within 3 calendar days after randomization.
- 3Weekly paclitaxel x 12 consecutive weeks
- 4Weekly paclitaxel x 12 consecutive weeks + carboplatin (weekly x 12 consecutive weeks or every 3 weeks x 4 consecutive cycles)
- 5Paclitaxel + carboplatin every 3 weeks x 6 consecutive cycles without chemotherapy pause for surgery
- 6Docetaxel + carboplatin every 3 weeks x 6 consecutive cycles without chemotherapy pause for surgery NOTE: For any of the protocol-specified chemotherapy regimens, concurrent targeted therapy with biologic therapy is allowed. Pembrolizumab (or other immune checkpoint inhibitors), trastuzumab and/or pertuzumab, or bevacizumab are allowed.
- 7Participant must be \>= 18 years old.
- 8Participants must be offered the opportunity to participate in specimen banking. With participant consent, specimens must be collected and submitted via the Southwest Oncology Group (SWOG) Specimen Tracking System.
- 9Participants must be able to complete Patient-Reported Outcome (PRO) questionnaires in English or Spanish.
- 10Participants must 1) agree to complete PROs at all scheduled assessments, and 2) complete the baseline PRO questionnaires within 14 days prior to randomization
- 11Participants must be informed of the investigational nature of this study and must sign and give informed consent in accordance with institutional and federal guidelines.
- 12For participants with impaired decision-making capabilities, legally authorized representatives may sign and give informed consent on behalf of study participants in accordance with applicable federal, local, and Central Institutional Review Board (CIRB) regulations.
Exclusion Criteria
- 1Participants must not have a history of skin or limb metastases.
- 2Participants must not have previously received neurotoxic chemotherapy for any reason (e.g., taxanes, platinum agents, vinca alkaloids, or bortezomib).
- 3Participants must not have pre-existing clinical peripheral neuropathy from any cause.
- 4Participants must not have a history of Raynaud's phenomenon, cold agglutinin disease, cryoglobulinemia, cryofibrinogenemia, post-traumatic cold dystrophy, or peripheral arterial ischemia.
- 5Participants must not have any open skin wounds or ulcers of the limbs at the time of randomization.
Locations
29 sites participating in this study
Emory University Hospital/Winship Cancer Institute
Atlanta, Georgia 30322
Demetria Smith-Graziani
University of Alabama at Birmingham Cancer Center
Birmingham, Alabama 35233
Ellen M. Smith
Contra Costa Regional Medical Center
Martinez, California 94553-3156
Nicholas DiBella