The Use of Cryotherapy to Prevent Paclitaxel-induced Peripheral Neuropathy and Nail Changes in Women With Breast Cancer

Parkview Health

Status

Terminated

Conditions

Peripheral Neuropathy

Nail Toxicity

Cryotherapy Effect

Treatments

Other: cryotherapy

Study type

Interventional

Funder types

Other

Identifiers

NCT04558034

NUR20-0124CRYO

Details and patient eligibility

About

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

Full 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.

Enrollment

14 patients

Sex

Female

Ages

18+ years old

Volunteers

No Healthy Volunteers

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