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

NCT04558034 | Terminated

• 1 other identifier: NUR20-0124CRYO
• Study Type: interventional
• Target: 14
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Cryotherapy Effect; Peripheral Neuropathy; Nail Toxicity

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (2)

Interventioncryotherapy/control

ACTIVE COMPARATOR

Subjects will have one mitt/one slipper and serve as their own control

Other: cryotherapy

standard of care

NO INTERVENTION

Subjects will have two mitts/slippers

Interventions

cryotherapy OTHER

cryotherapy will be delivered

Interventioncryotherapy/control

Eligibility Criteria

• Age: 18 Years+
• Gender Eligibility Details: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Parkview Health: lead

Study Sites (1)

Parkview Cancer Institute

Fort Wayne, Indiana, 46845, United States

Location

Related Publications (69)

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MeSH Terms

Conditions

Peripheral Nervous System Diseases

Interventions

Cryotherapy

Condition Hierarchy (Ancestors)

Neuromuscular Diseases; Nervous System Diseases

Intervention Hierarchy (Ancestors)

Therapeutics

Study Officials

• Danielle R Payne, MSN

  Parkview Health

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Prinicipal Investigator

Model Details: 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.

Study Record Dates

• First Submitted: September 3, 2020
• First Posted: September 22, 2020
• Study Start: August 4, 2020
• Primary Completion: February 3, 2021
• Study Completion: February 3, 2021
• Last Updated: March 8, 2021

Record last verified: 2021-03

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
• Time Frame: Immediately following publication and no end date
• Access Criteria: Data will be available to anyone who wishes to access the data for any purpose by contacting nancy.ehmke@parkview.com

Locations

US (1)