Clinical trial NCT06139458: Cryocompression to Reduce Chemotherapy-induced Peripheral Neuropathy in Gynecologic Cancer - COHORT 2
Official title: Use of Cryocompression to Reduce Chemotherapy-induced Peripheral Neuropathy in Gynecologic Cancer: a Randomized Controlled Trial - COHORT 2
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Gynecologic Cancer
Chemotherapy-induced Peripheral Neuropathy
Lead sponsor: Duke University
Sponsor class: OTHER
First posted: 2023-11-18
Enrollment: 190
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief 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.

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 or at the Carilion Clinic in Roanoke, VA. 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.

Primary outcomes:
measure: Change in Functional Assessment of Cancer Therapy (FACT) -Taxane [FACT-NTX] (patient reported assessment) over time
timeFrame: Up to two months after completion of chemotherapy, an average of 6 months
Secondary outcomes:
measure: Tolerability of cryocompression: scale
timeFrame: Up to two months after completion of chemotherapy, an average of 6 months
measure: Acceptability: scale
timeFrame: Up to two months after completion of chemotherapy, an average of 6 months
measure: Measure of manageability and acceptability for staff involved in the participants' care
timeFrame: Up to two months after completion of chemotherapy, an average of 6 months
measure: Change in Patient Neurotoxicity Questionnaire [PNQ] (patient reported assessment) over time
timeFrame: Up to two months after completion of chemotherapy, an average of 6 months
measure: Chemotherapy Dose
timeFrame: Up to two months after completion of chemotherapy, an average of 6 months
Other outcomes:
Locations:
city: Durham
country: United States
facility: Duke University Medical Center
state: North Carolina
city: Roanoke
country: United States
facility: Carilion Clinic
state: Virginia
Study officials:
affiliation: DUHS
name: Laura Havrilesky
role: PRINCIPAL_INVESTIGATOR
References: