Clinical trial NCT04563130: Cryocompression to Reduce Chemotherapy-induced Peripheral Neuropathy in Gynecologic Cancer
Official title: Use of Cryocompression to Reduce Chemotherapy-induced Peripheral Neuropathy in Gynecologic Cancer: a Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Gynecologic Cancer
Chemotherapy-induced Peripheral Neuropathy
Lead sponsor: Duke University
Sponsor class: OTHER
First posted: 2020-09-24
Enrollment: 91
Sex: FEMALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The aim of this study is to evaluate the effect of cryocompression therapy on the incidence and degree of taxane-induced peripheral neuropathy in gynecologic cancer patients receiving chemotherapy. Subjects will serve as their own controls, and will be randomized to cryocompression therapy on their dominant versus non-dominant hand and foot, with standard of care treatment (no intervention) on the opposite hand and foot. Compression therapy will be performed using commercially available compression socks and disposable surgical gloves, and cryotherapy will be achieved by applying bags of ice to the compression devices. Subjects will complete baseline neuropathy surveys including the Patient Neurotoxicity Questionnaire (PNQ) and the Functional Assessment of Cancer Therapy (FACT) -Taxane (FACT-NTX), which includes the sensory subscale of the FACT-NTX. Subjective symptoms will be assessed at baseline, before each cycle of chemotherapy and cryocompression, and one month after completion of 6 cycles. In addition, tactile sensation will be assessed with the monofilament test at baseline and one month after completion of 6 cycles of chemotherapy and cryocompression. The primary outcomes are the proportion of patients with PNQ grade C or higher and decline in tactile sensitivity from baseline based on the monofilament test. The investigators hypothesize that cryocompression will reduce chemotherapy-induced peripheral neuropathy in patients with gynecologic cancer.


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 Duke Cancer Institute. Patients receiving neoadjuvant chemotherapy with a plan for interval debulking will be eligible.
* ECOG performance status of 0-1
* Latex allergy does not exclude a subject from the study. Non-latex gloves will be provided.

Exclusion Criteria:

* Treated with prior neurotoxic chemotherapeutic agents
* Baseline diagnosis of peripheral neuropathy such as diabetic neuropathy, or associated with conditions including but not limited to fibromyalgia, cryoglobulinemia and Raynaud's disease.

Primary outcomes:
measure: Change in Patient Neurotoxicity Questionnaire [PNQ] (patient reported assessment) over time
timeFrame: baseline, after each dose of paclitaxel and cryocompression, and one month after completion of chemotherapy.
measure: Change in Semmes-Weinstein monofilament test (tactile disturbance) over time
timeFrame: baseline, one month after completion of chemotherapy.
Secondary outcomes:
measure: Change in Functional Assessment of Cancer Therapy (FACT) -Taxane [FACT-NTX] (patient reported assessment) over time
timeFrame: baseline, after each dose of paclitaxel and cryocompression, and one month after completion of chemotherapy.
measure: Tolerability of cryocompression: scale
timeFrame: after each dose of paclitaxel and cryocompression
measure: Acceptability: scale
timeFrame: immediately after the intervention
Other outcomes:
Locations:
city: Durham
country: United States
facility: Duke University Medical Center
state: North Carolina
Study officials:
affiliation: Duke University Hospital
name: Laura Havrilesky, MD, MHSc
role: PRINCIPAL_INVESTIGATOR
References: