Purpose of this Study
We are doing this study to find out if using ice with or without compression during chemotherapy can prevent neuropathy for patients being treated for gynecologic cancer.
Who Can Participate?
Eligibility
Adults ages 18+ who:<ul>
<li>Are diagnosed with a gynecological cancer</li>
<li>Are receiving a taxane chemotherapy for the first time</li>
<li>Are scheduled to have at least 6 cycles of a taxane chemotherapy</li>
<li>Do not have pre-existing neuropathy</li></ul>
For more information about this study, please contact the study team at <a href= "mailto: amelia.lorenzo@duke.edu">amelia.lorenzo@duke.edu.</a>
<li>Are diagnosed with a gynecological cancer</li>
<li>Are receiving a taxane chemotherapy for the first time</li>
<li>Are scheduled to have at least 6 cycles of a taxane chemotherapy</li>
<li>Do not have pre-existing neuropathy</li></ul>
For more information about this study, please contact the study team at <a href= "mailto: amelia.lorenzo@duke.edu">amelia.lorenzo@duke.edu.</a>
Age Range
19-110
Sex/Genders
Female (cisgender)
Transgender male
Looking for Healthy Participants
No
What is Involved?
If you choose to join this study, you will get a random assignment (like a coin flip) to either:<ul>
<li>Get treatment with cryotherapy (ice packs) alone; OR</li>
<li>Get treatment with cryotherapy and compression</li></ul>
All participants will wear their ice packs on their hands and feet (with or without compression) for the duration of each of their chemotherapy infusions. Study team members will assist with setting up and taking off the wraps. We will ask a few questions at the start of the infusion about your neuropathy symptoms, and we will ask a few questions about your experience after the infusion is done.
<li>Get treatment with cryotherapy (ice packs) alone; OR</li>
<li>Get treatment with cryotherapy and compression</li></ul>
All participants will wear their ice packs on their hands and feet (with or without compression) for the duration of each of their chemotherapy infusions. Study team members will assist with setting up and taking off the wraps. We will ask a few questions at the start of the infusion about your neuropathy symptoms, and we will ask a few questions about your experience after the infusion is done.
Locations
Duke University Hospital
Duke Raleigh Hospital
Visit Timing
Weekdays
Compensation
No
Spanish Materials Available
Yes
Study Details
Full Title
Use of cryocompression to reduce chemotherapy-induced peripheral neuropathy in gynecologic cancer: a randomized controlled trial
Principal Investigator
Laura
Havrilesky
Protocol Number
PRO00106236
NCT ID
NCT04563130
Phase
N/A
Enrollment Status
Open to Enrollment