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Email CoordinatorOverview:
S2205: ice compress: randomized trial of limb cryocompression versus continuous compression versus low cyclic compression for the prevention of taxane-induced peripheral neuropathy.
The purpose of this study is to learn which of the 3 study approaches is the most helpful to prevent peripheral neuropathy caused by taxane chemotherapy. These approaches will use a study device, called the Paxman Limb Cryocompression System, made of wraps that cool and/or compress your arms and legs. The study will test which of the following combinations of cooling and/or compression to your arms and legs is better at preventing peripheral neuropathy:
- Cryocompression (cooling plus moderate and low pressure to your arms and legs)
- Continuous compression (moderate, steady pressure to your arms and legs)
- Low cyclic compression (low pressure that comes and goes to your arms and legs)
There will be about 777 people taking part in this study.
Participants must have a diagnosis of a solid tumor malignancy.
Participants 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.
Weekly paclitaxel x 12 consecutive weeks
Weekly paclitaxel x 12 consecutive weeks + carboplatin (weekly x 12 consecutive weeks or every 3 weeks x 4 consecutive cycles)
Paclitaxel + carboplatin every 3 weeks x 6 consecutive cycles without chemotherapy pause for surgery
Docetaxel + 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.
Participant must be >= 18 years old.
Participants 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.
Participants must be able to complete Patient-Reported Outcome (PRO) questionnaires in English or Spanish.
Participants must 1) agree to complete PROs at all scheduled assessments, and 2) complete the baseline PRO questionnaires within 14 days prior to randomization
Participants must be informed of the investigational nature of this study and must sign and give informed consent in accordance with institutional and federal guidelines.
For 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:
Participants must not have a history of skin or limb metastases.
Participants must not have previously received neurotoxic chemotherapy for any reason (e.g., taxanes, platinum agents, vinca alkaloids, or bortezomib).
Participants must not have pre-existing clinical peripheral neuropathy from any cause.
Participants must not have a history of Raynaud's phenomenon, cold agglutinin disease, cryoglobulinemia, cryofibrinogenemia, post-traumatic cold dystrophy, or peripheral arterial ischemia.
Participants must not have any open skin wounds or ulcers of the limbs at the time of randomization.