The Use of Cryotherapy to Prevent Paclitaxel-induced Peripheral Neuropathy and Nail Changes in Women With Breast Cancer
NCT ID: NCT04558034
Last Updated: 2021-03-08
Study Results
Results pending
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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Recruitment Status
TERMINATED
Clinical Phase
NA
Total Enrollment
14 participants
Study Classification
INTERVENTIONAL
Study Start Date
2020-08-04
Study Completion Date
2021-02-03
Brief Summary
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This study will determine the efficacy of cryotherapy to prevent paclitaxel-induced peripheral neuropathy and nail changes in women with breast cancer.
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Detailed Description
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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.
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.
Conditions
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Cryotherapy Effect
Peripheral Neuropathy
Nail Toxicity
Study Design
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Allocation Method
NON_RANDOMIZED
Intervention Model
PARALLEL
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.
* 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 Study Purpose
PREVENTION
Blinding Strategy
NONE
Study Groups
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Interventioncryotherapy/control
Subjects will have one mitt/one slipper and serve as their own control
Group Type
ACTIVE_COMPARATOR
cryotherapy
Intervention Type
OTHER
cryotherapy will be delivered
standard of care
Subjects will have two mitts/slippers
Group Type
NO_INTERVENTION
No interventions assigned to this group
Interventions
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cryotherapy
cryotherapy will be delivered
Intervention Type
OTHER
Eligibility Criteria
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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
* 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
* 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
Minimum Eligible Age
18 Years
Eligible Sex
FEMALE
Accepts Healthy Volunteers
No
Sponsors
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Parkview Health
OTHER
Sponsor Role
lead
Responsible Party
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Danielle Payne
Prinicipal Investigator
Responsibility Role
PRINCIPAL_INVESTIGATOR
Principal Investigators
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Danielle R Payne, MSN
Role: PRINCIPAL_INVESTIGATOR
Parkview Health
Locations
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Parkview Cancer Institute
Fort Wayne, Indiana, United States
Site Status
Countries
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United States
References
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Other Identifiers
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NUR20-0124CRYO
Identifier Type: -
Identifier Source: org_study_id
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NA
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RECRUITING
NA
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COMPLETED
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RECRUITING
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PHASE3
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UNKNOWN
PHASE2
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UNKNOWN
NA
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UNKNOWN
NA
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UNKNOWN
NA
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UNKNOWN
NA
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COMPLETED
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