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

Not Applicable

Terminated

• Conditions: Peripheral Neuropathy; Cryotherapy Effect; Nail Toxicity
• Interventions: Other: cryotherapy

• Registration Number: NCT04558034
• Lead Sponsor: Parkview Health

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.

Study Timeline

• Study Start: 2020-08-04
• Study First Submitted: 2020-09-03
• Study First Submitted QC: 2020-09-15
• Study First Posted: 2020-09-22
• Primary Completion: 2021-02-03
• Study Completion: 2021-02-03
• Status Verified: 2021-03
• Last Update Submitted: 2021-03-04
• Last Update Posted: 2021-03-08

Recruitment & Eligibility

• Status: TERMINATED
• Sex: Female
• Target Recruitment: 14

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Interventioncryotherapy/control	cryotherapy	Subjects will have one mitt/one slipper and serve as their own control

Primary Outcome Measures

Name	Time	Method
Numbness,tingling,pain ,nail toxicities	13 weeks	absence of numbness and tingling in the treated hands/feet; * If there is an absence of pain in the treated hands/feet; * If there is an absence of nail changes in the treated hands/feet

Trial Locations

Locations (1)

Parkview Cancer Institute; 🇺🇸 Fort Wayne, Indiana, United States