Back to resultsCryotherapy for the Prevention of Taxane-Induced Sensory Neuropathy of the Hands and Feet in Breast Cancer Patients
Primary Purpose
Breast Carcinoma
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Medical Device Usage and Evaluation
Questionnaire Administration
Sponsored by
About this trial
This is an interventional supportive care trial for Breast Carcinoma
Eligibility Criteria
Inclusion Criteria:
- Patients >= 18 years of age with a diagnosis of breast cancer
- Patients receiving 12-18 weeks of chemotherapy with a taxane-based regimen (4 cycles of weekly x 3 paclitaxel or 4-6 cycles of docetaxel every 3 weeks)
- Absence of sensory peripheral neuropathy, skin or nail disorders at the start of treatment
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2
- Ability to complete questionnaires by themselves or with assistance
- Ability to give signed informed consent
Exclusion Criteria:
- History of prior sensory/motor peripheral neuropathy from any cause
- History of prior Raynaud's phenomenon
- History of cryoglobulinemia
- Active peripheral vascular disease
- Cold intolerance
- Prior exposure to neurotoxic chemotherapy in the last 10 years
- Hand-foot syndrome
- Tumor metastasis in bone, soft tissue, or skin of the hands or feet
- Absence of one or more fingers or toes
- Prior exposure to taxane chemotherapy
Sites / Locations
- Mayo Clinic in Florida
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Prevention (Elasto Gel Therapy Mittens and Foot Wraps)
Arm Description
Patients wear Elasto Gel Therapy Mittens and Foot Wraps on both hands and feet 15 minutes prior to each infusion, during the entire infusion, and for 15 minutes after the completion of each infusion during their three months of treatment.
Outcomes
Primary Outcome Measures
Peripheral neuropathy (PN)
The overall estimate of PN in the group will be estimated with a simple percentage, and 95% confidence intervals will be calculated for that estimate. In additional other measures of symptoms or other parameters will be summarized in the group. Categorical parameters will be estimated using percentages, and continuous measures will be summarized using means, or medians. The decision about which measure to use for the continuous measures will depend on the distribution of the data of interest.
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04256512
Brief Title
Cryotherapy for the Prevention of Taxane-Induced Sensory Neuropathy of the Hands and Feet in Breast Cancer Patients
Official Title
Cryotherapy to Prevent Taxane-Induced Sensory Neuropathy of the Hands and Feet
Study Type
Interventional
2. Study Status
Record Verification Date
June 2023
Overall Recruitment Status
Completed
Study Start Date
March 10, 2020 (Actual)
Primary Completion Date
January 18, 2023 (Actual)
Study Completion Date
January 18, 2023 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Mayo Clinic
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Data Monitoring Committee
No
5. Study Description
Brief Summary
This clinical trial investigates the effect and tolerability of cryotherapy and to evaluate whether they can prevent or improve taxane-induced sensory peripheral neuropathy in breast cancer patients. Cryosurgery, also known as cryoablation or cryotherapy, kills tumor cells by freezing them. Patients receiving cryotherapy during infusion of taxane therapy may have lower incidence of peripheral neuropathy, better physical function, and higher quality of life as compared to patients previously reported in literature.
Detailed Description
PRIMARY OBJECTIVE:
I. To investigate the efficacy and tolerability of cryotherapy (Elasto Gel frozen mittens and foot wraps) and to evaluate whether they can prevent or ameliorate taxane-induced sensory peripheral neuropathy.
OUTLINE:
Patients wear Elasto Gel Therapy Mittens and Foot Wraps on both hands and feet 15 minutes prior to each infusion, during the entire infusion, and for 15 minutes after the completion of each infusion during their three months of treatment.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Breast Carcinoma
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
94 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Prevention (Elasto Gel Therapy Mittens and Foot Wraps)
Arm Type
Experimental
Arm Description
Patients wear Elasto Gel Therapy Mittens and Foot Wraps on both hands and feet 15 minutes prior to each infusion, during the entire infusion, and for 15 minutes after the completion of each infusion during their three months of treatment.
Intervention Type
Device
Intervention Name(s)
Medical Device Usage and Evaluation
Intervention Description
Wear Elasto Gel Therapy Mittens and Foot Wraps
Intervention Type
Other
Intervention Name(s)
Questionnaire Administration
Intervention Description
Ancillary studies
Primary Outcome Measure Information:
Title
Peripheral neuropathy (PN)
Description
The overall estimate of PN in the group will be estimated with a simple percentage, and 95% confidence intervals will be calculated for that estimate. In additional other measures of symptoms or other parameters will be summarized in the group. Categorical parameters will be estimated using percentages, and continuous measures will be summarized using means, or medians. The decision about which measure to use for the continuous measures will depend on the distribution of the data of interest.
Time Frame
Up to 3 months post chemotherapy
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Patients >= 18 years of age with a diagnosis of breast cancer
Patients receiving 12-18 weeks of chemotherapy with a taxane-based regimen (4 cycles of weekly x 3 paclitaxel or 4-6 cycles of docetaxel every 3 weeks)
Absence of sensory peripheral neuropathy, skin or nail disorders at the start of treatment
Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2
Ability to complete questionnaires by themselves or with assistance
Ability to give signed informed consent
Exclusion Criteria:
History of prior sensory/motor peripheral neuropathy from any cause
History of prior Raynaud's phenomenon
History of cryoglobulinemia
Active peripheral vascular disease
Cold intolerance
Prior exposure to neurotoxic chemotherapy in the last 10 years
Hand-foot syndrome
Tumor metastasis in bone, soft tissue, or skin of the hands or feet
Absence of one or more fingers or toes
Prior exposure to taxane chemotherapy
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Pooja Advani
Organizational Affiliation
Mayo Clinic
Official's Role
Principal Investigator
Facility Information:
Facility Name
Mayo Clinic in Florida
City
Jacksonville
State/Province
Florida
ZIP/Postal Code
32224-9980
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Cryotherapy for the Prevention of Taxane-Induced Sensory Neuropathy of the Hands and Feet in Breast Cancer Patients
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