Evaluating the Use of Limb Cryocompression to Reduce Taxane-induced Peripheral Neuropathy

Status: Recruiting
Location: See location...
Intervention Type: Device
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY

This study aims to evaluate the effectiveness, tolerability, and safety of using cooling therapy and pressure (cryocompression) to reduce peripheral neuropathy, a condition affecting the nerves supplying the arms and legs (limbs) resulting in possible numbness, pain, and/or loss of motor function, that may occur as a result of taxane-based chemotherapy. The name of the device used in this research study is: -Paxman Limb Cryocompression System (PLCS)

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• Adults \> 18 years of age

• Gynecologic or breast malignancy

• Starting 1st cycle of treatment with chemotherapy regimens:

‣ Weekly paclitaxel x 12 or weekly paclitaxel/carboplatin x 12 (Breast Oncology)

⁃ Q3 weeks paclitaxel/carboplatin X 6-8 (GYN)

• Receiving treatment on the main campus of DFCI (these patients are currently seen on Yawkey 9 and 10 and at Chestnut Hill)

• Able to complete questionnaires in English or Spanish

Locations
United States
Massachusetts
Dana-Farber Cancer Institute
RECRUITING
Boston
Contact Information
Primary
Theresa Jabaley Leonarczyk, PhD, RN
theresa_jabaley@dfci.harvard.edu
617-582-8037
Backup
Jabaley Leonarczyk, PhD, RN
theresa_jabaley@dfci.harvard.edu
617-582-8037
Time Frame
Start Date: 2025-10-22
Estimated Completion Date: 2027-08
Participants
Target number of participants: 50
Treatments
Experimental: Arm A: Cryocompression + Standard of Care Taxane-Based Chemotherapy
Participants will be randomized and stratified by chemotherapy regimen and will complete:~* Baseline visit with questionnaires~* Standard of care chemotherapy visits with cryocompression~* End of treatment visit
No_intervention: Arm B: Standard of Care Taxane-based Chemotherapy
Participants will be randomized and stratified by chemotherapy regimen and will complete:~* Baseline visit with questionnaires~* Standard of care chemotherapy visits~* End of treatment visit
Related Therapeutic Areas
Sponsors
Leads: Dana-Farber Cancer Institute

This content was sourced from clinicaltrials.gov