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Trial Title:
Cryocompression to Reduce Chemotherapy-induced Peripheral Neuropathy in Gynecologic Cancer - COHORT 2
NCT ID:
NCT06139458
Condition:
Gynecologic Cancer
Chemotherapy-induced Peripheral Neuropathy
Conditions: Official terms:
Peripheral Nervous System Diseases
Study type:
Interventional
Study phase:
N/A
Overall status:
Recruiting
Study design:
Allocation:
Randomized
Intervention model:
Parallel Assignment
Primary purpose:
Prevention
Masking:
None (Open Label)
Intervention:
Intervention type:
Behavioral
Intervention name:
Cryotherapy
Description:
Participants will receive cryotherapy on both hands and feet
Arm group label:
Compression with Cryotherapy
Arm group label:
Cryotherapy
Intervention type:
Behavioral
Intervention name:
Compression
Description:
Participants will receive compression on both hands and feet
Arm group label:
Compression with Cryotherapy
Summary:
The investigators aim to determine the effect of cryotherapy wraps plus compression
therapy (henceforth referred to as cryocompression) versus cryotherapy wraps alone on the
incidence and degree of chemotherapy-induced peripheral neuropathy in patients with
gynecologic cancer using a noninferiority design. The investigators also aim to determine
the effect of cryocompression versus cryotherapy on patient tolerability and patient and
staff satisfaction.
Detailed description:
Participants will be randomized by patient to receive cryotherapy wraps plus compression
therapy (cryocompression) versus cryotherapy wraps alone applied to the bilateral hands
and feet. Participants will receive cryotherapy (+/- compression) for the duration of
their taxane infusions. Participants will be asked to complete the FACT-NTX survey and a
PNQ neuropathy surveys at each infusion visit to evaluate symptoms related to neuropathy.
Participants will also complete a brief acceptability and tolerability survey at each
visit. Lastly, a staff satisfaction survey will be administered at each visit as well.
The investigators will test the hypothesis that the average final visit FACT-NTX11 scores
in the cryotherapy group are noninferior to the cryocompression group with a
noninferiority margin of 2.5 points. The investigators will routinely monitor for the
following adverse events: frost bite, (unexpected) hospitalizations, and death.
Criteria for eligibility:
Criteria:
Inclusion Criteria:
- Gynecologic cancer diagnosis (ovarian, cervical, endometrial cancer; adenocarcinomas
of likely primary gynecologic origin based on cytology or FNA in conjunction with
radiologic impression will be eligible)
- Plan to receive at least 6 cycles of paclitaxel administered every 3 weeks at the
Duke Cancer Center or Macon Pond. Patients receiving neoadjuvant chemotherapy with a
plan for interval debulking will be eligible.
- ECOG (Eastern Cooperative Oncology Group) performance status of 0-1
Exclusion Criteria:
- Treated with prior neurotoxic chemotherapeutic agents
- Baseline diagnosis of peripheral neuropathy such as diabetic neuropathy, or
conditions including but not limited to fibromyalgia, cryoglobulinemia and Raynaud's
disease.
Gender:
Female
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
Duke University Medical Center
Address:
City:
Durham
Zip:
27710
Country:
United States
Status:
Recruiting
Contact:
Last name:
Laura Havrilesky, MD
Phone:
919-684-0126
Email:
laura.havrilesky@duke.edu
Investigator:
Last name:
Laura Havrilesky, MD
Email:
Principal Investigator
Start date:
January 18, 2024
Completion date:
May 31, 2027
Lead sponsor:
Agency:
Duke University
Agency class:
Other
Source:
Duke University
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06139458
