SWOG clinical trial number
              S2205
          ICE COMPRESS: Randomized Trial of Limb Cryocompression versus Continuous Compression Versus Low Cyclic Compression for the Prevention of Taxane-Induced Peripheral Neuroropathy
Open
      
  Phase
              Accrual
  
                          
      52%
      
  
    Abbreviated Title
              ICE COMPRESS
          Status Notes
              This study is open to patient accrual effective 3/16/23 at 12 p.m. Pacific Time.
          Activated
              03/16/2023
          Research committees
Symptom Control and Quality of Life
Patient Study Materials
Patient Clinical Trial Summary
            Download PDF of Patient Clinical Trial Summary
Eligibility Criteria Expand/Collapse
      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 for 12 consecutive weeks
•Weekly paclitaxel for 12 consecutive weeks plus carboplatin (weekly for 12 consecutive weeks or every 3 weeks for 4 consecutive cycles)
•Paclitaxel plus carboplatin every 3 weeks for 6 consecutive cycles without chemotherapy pause for surgery
•Docetaxel plus carboplatin every 3 weeks for 6 consecutive cycles without chemotherapy pause for surgery.
Participants must not have previously received neurotoxic chemotherapy for any reason (e.g., taxanes, platinum agents, vinca alkaloids, or bortezomib); Participants must be >/+= 18 years old; must not have pre-existing clinical peripheral neuropathy from any cause; must not have a history of Raynaud’s phenomenon, cold agglutinin disease, cryoglobulinemia, cryofibrinogenemia, post-traumatic cold dystrophy, or peripheral arterial ischemia; and must not have any open skin wounds or ulcers of the limbs at the time of randomization. Participants must be offered the opportunity to participate in specimen banking, must be able to complete PRO questionnaires in English or Spanish and must agree to complete the PRO questionnaires at all scheduled assessments.
      
  
    •Weekly paclitaxel for 12 consecutive weeks
•Weekly paclitaxel for 12 consecutive weeks plus carboplatin (weekly for 12 consecutive weeks or every 3 weeks for 4 consecutive cycles)
•Paclitaxel plus carboplatin every 3 weeks for 6 consecutive cycles without chemotherapy pause for surgery
•Docetaxel plus carboplatin every 3 weeks for 6 consecutive cycles without chemotherapy pause for surgery.
Participants must not have previously received neurotoxic chemotherapy for any reason (e.g., taxanes, platinum agents, vinca alkaloids, or bortezomib); Participants must be >/+= 18 years old; must not have pre-existing clinical peripheral neuropathy from any cause; must not have a history of Raynaud’s phenomenon, cold agglutinin disease, cryoglobulinemia, cryofibrinogenemia, post-traumatic cold dystrophy, or peripheral arterial ischemia; and must not have any open skin wounds or ulcers of the limbs at the time of randomization. Participants must be offered the opportunity to participate in specimen banking, must be able to complete PRO questionnaires in English or Spanish and must agree to complete the PRO questionnaires at all scheduled assessments.
Other Clinical Trials
SWOG Clinical Trial Number
              S2205
          ICE COMPRESS: Randomized Trial of Limb Cryocompression versus Continuous Compression Versus Low Cyclic Compression for the Prevention of Taxane-Induced Peripheral Neuroropathy
Research Committee(s)
      
            Symptom Control and Quality of Life
Activated
              03/16/2023
          Accrual
  
                          
      52%
      
  
    Open
      
  Phase
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Research Committee(s)
      
            Symptom Control and Quality of Life
Activated
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          Open
      
  Phase
              SWOG Clinical Trial Number
              S2013
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Research Committee(s)
      
            Symptom Control and Quality of Life
Activated
              08/16/2021
          Accrual
  
                          
      62%
      
  
    Open
      
  Phase
              