Ice Compress: Randomized Trial of Limb Cryocompression Versus Continuous Compression Versus Low Cyclic Compression for the Prevention of Taxane-Induced Peripheral Neuropathy
SWOG Cancer Research Network
Summary
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.
Description
PRIMARY OBJECTIVE: I. To compare the proportion of participants who develop clinically meaningful chemotherapy induced peripheral neuropathy (CIPN) at 12 weeks, in participants treated with taxane-based chemotherapy randomized to cryocompression therapy versus continuous compression therapy versus low cyclic compression therapy. SECONDARY OBJECTIVES: I. To compare trajectories over time (6, 12, 24, and 52 weeks) by intervention study arm in clinically meaningful CIPN. II. To compare mean European Organization for Research and Treatment of Cancer Chemotherapy-Induced Peripheral Neuropathy 2…
Eligibility
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- No
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 + carbop…
Interventions
- ProcedureBiospecimen Collection
Undergo collection of blood, plasma, and serum
- ProcedureCryocompression Therapy
Undergo cryocompression
- ProcedurePneumatic Compression Therapy
Undergo continuous compression
- ProcedurePneumatic Compression Therapy
Undergo low cyclic compression
- OtherQuality-of-Life Assessment
Ancillary studies
- OtherQuestionnaire Administration
Ancillary studies
Locations (36)
- University of Alabama at Birmingham Cancer CenterBirmingham, Alabama
- Contra Costa Regional Medical CenterMartinez, California
- Smilow Cancer Hospital Care Center-FairfieldFairfield, Connecticut
- Yale UniversityNew Haven, Connecticut
- Smilow Cancer Hospital Care Center-TrumbullTrumbull, Connecticut
- Emory University Hospital/Winship Cancer InstituteAtlanta, Georgia