Clinical trial NCT04558034: The Use of Cryotherapy to Prevent Paclitaxel-induced Peripheral Neuropathy and Nail Changes in Women With Breast Cancer
Official title: The Use of Cryotherapy to Prevent Paclitaxel-induced Peripheral Neuropathy and Nail Changes in Women With Breast Cancer
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Cryotherapy Effect
Peripheral Neuropathy
Nail Toxicity
Lead sponsor: Parkview Health
Sponsor class: OTHER
First posted: 2020-09-22
Enrollment: 14
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Intervention model description: There are 2 arms to the study.The Elasto-gel mitt and Rapid Relief slipper will be placed either on one hand/foot or both based on the patient's medical oncologist. All subjects will have a standardized onset/duration of therapy which includes the following :

* 15 minutes prior to the paclitaxel infusion,
* Continuously during the paclitaxel infusion,
* 15 minutes after completion of paclitaxel for a total of 90 minutes.
Primary purpose: PREVENTION

Brief summary: This study will determine the efficacy of cryotherapy to prevent paclitaxel-induced peripheral neuropathy and nail changes in women with breast cancer.

Detailed description: Women with breast cancer receiving paclitaxel will complete the Brief Pain Inventory(BPI), Neuropathic Pain Syndrome Inventory (NPSI)while a member of the research team will conduct an assessment of their nails. Once complete, cryotherapy will be administered 15 minutes prior to the paclitaxel infusion, continuously during and then 15 minutes after completion of the paclitaxel for a total of 90 minutes. Cyrotherapy will be delivered using Elasto-gel mitts and Rapid relief slippers. These items will be changed 45min after initiation to ensure coldness.

There will be two arms of the study. One arm will include subjects who will wear one slipper/one mitt on their foot/hand while the other foot/hand will serve as a control. The other arm will include subjects who will have cryotherapy to both hands and feet. . This process will be repeated for a total of 12 times in conjunction with 12 doses of paclitaxel. At time point 13, during a routine visit to their oncologist, the subjects nails will be reassessed along with completion of the BPI and NPSIA total of 25 subjects will be enrolled in each arm.

Eligibility criteria: Inclusion Criteria:

* Females 18 or older
* Histologically confirmed diagnosis of breast cancer
* Receiving neo-adjuvant or adjuvant dose-dense anthracycline (AC) plus taxane-based chemotherapy or paclitaxel in combination with trastuzumab and pertuzumab

Exclusion Criteria:

* Prior taxane therapy
* Prior oxaliplatin therapy
* Non-English speaking
* History of peripheral neuropathy, i.e., Buerger's disease
* History of diabetes mellitus
* Pre-existing peripheral neuropathy from other conditions, e.g., Raynaud's disease, Guillain-Barre, Miller Fisher Syndrome
* Hand, nail or foot conditions, e.g., hand/foot syndrome, arthritis, hammer toe, carpal tunnel, bunions, deformities
* Alcohol abuse (history/current)
* Current medication usage of opioids, anti-depressants, anti-convulsants, glutamines, vitamin B12

Primary outcomes:
measure: Numbness,tingling,pain ,nail toxicities
timeFrame: 13 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Fort Wayne
country: United States
facility: Parkview Cancer Institute
state: Indiana
Study officials:
affiliation: Parkview Health
name: Danielle R Payne, MSN
role: PRINCIPAL_INVESTIGATOR
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