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.
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)
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.
Parallel
Biospecimen Collection
Procedure/SurgeryUndergo collection of blood, plasma, and serum
Cryocompression Therapy
Procedure/SurgeryUndergo cryocompression
Pneumatic Compression Therapy
Procedure/SurgeryUndergo continuous compression
Pneumatic Compression Therapy
Procedure/SurgeryUndergo low cyclic compression
Quality-of-Life Assessment
Other interventionAncillary studies
Questionnaire Administration
Other interventionAncillary studies
Occurrence of clinically meaningful chemotherapy induced peripheral neuropathy (CIPN) (binary outcome: yes vs. no)
Defined as an absolute increase of 8 or more points over baseline in the CIPN-20 sensory neuropathy subscale score. Analysis will be conducted multivariable logistic regression, adjusting for the baseline score and the stratification factor as covariates.
Mean sensory neuropathy scores
Will assess by study arm. Will examine the CIPN-20 sensory neuropathy subscale score as a continuous variable on the 0-100 scale. The differences by intervention study arm at 12 weeks in changes from baseline in objective sensory and motor function tests (Neuorpen, tuning fork, Get Up and Go test) will also be compared. Multiple linear regression analysis will be conducted, adjusting for the baseline score and the stratification factor as covariates.
Dropouts
Any dropouts prior to the week 12 assessment as failures. Since death is anticipated to be unrelated to the intervention assignment, deaths will be censored. Failures will be analyzed with an aggregate failure variable defined as: experience of neuropathy according to the CIPN-20 sensory neuropathy subscale score or dropout prior to week 12 (yes vs. no). Logistic regression will be used, adjusted for the stratification factor as a covariate.
Trajectories over time
Trajectories over time by intervention study arm in clinically meaningful CIPN will be compared. Generalized estimating equations with a logit link and robust standard errors will be used, adjusting for the baseline score and the stratification factor as covariates.
Rates of adverse events
Rates of adverse events related to study device (including cold intolerance, skin changes, other AEs as assessed by (National Cancer Institute Common Terminology Criteria for Adverse Events \[NCI-CTCAE\]) between the three interventions will be compared.
Click on the lead sponsor to view all of their trials.
SWOG Cancer Research Network
Lead sponsor
National Cancer Institute (NCI)
Collaborator
