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Comparing Cooling and/or Compression Approaches of Limbs for Prevention of Chemotherapy-Induced Peripheral Neuropathy

RecruitingPhase 3Ages 18 Years - anyAllSWOG Cancer Research Network
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In plain words

What the trial is, and whether it could suit you

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.

Sign in to get the eligibility rules as simple questions to take to your doctor.

๐Ÿ“‹ Eligibility rules (as published)
Inclusion Criteria: * 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.
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What it tests

  • Biospecimen Collection
  • Cryocompression Therapy
  • Pneumatic Compression Therapy
  • Pneumatic Compression Therapy
  • Quality-of-Life Assessment
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Where

36 sites
University of Alabama at Birmingham Cancer Center
Birmingham, United States
Contra Costa Regional Medical Center
Martinez, United States
Smilow Cancer Hospital Care Center-Fairfield
Fairfield, United States
Yale University
New Haven, United States
Smilow Cancer Hospital Care Center-Trumbull
Trumbull, United States
Emory University Hospital/Winship Cancer Institute
Atlanta, United States
Kapiolani Medical Center for Women and Children
Honolulu, United States
University of Kansas Cancer Center
Kansas City, United States

โ€ฆand 28 more on ClinicalTrials.gov.

๐Ÿค Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible โ€” always decide together with your own doctor.
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