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

Peripheral Neuropathy Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT04558034
• Other study ID #: NUR20-0124CRYO
• Status: Terminated
• Phase: N/A
• Start date: August 4, 2020
• Est. completion date: February 3, 2021

Study information

• Verified date: March 2021
• Source: Parkview Health
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 14
• Est. completion date: February 3, 2021
• Est. primary completion date: February 3, 2021
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Cryotherapy Effect
• Nail Toxicity
• Peripheral Nervous System Diseases
• Peripheral Neuropathy

Intervention

Other:
• cryotherapy
cryotherapy will be delivered

Locations

Country	Name	City	State
United States	Parkview Cancer Institute	Fort Wayne	Indiana

Sponsors (1)

Lead Sponsor	Collaborator
Parkview Health

Country where clinical trial is conducted

United States, 

References & Publications (69)

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Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Numbness,tingling,pain ,nail toxicities	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	13 weeks