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| ID | Type | Description | Link |
|---|---|---|---|
| NCI-2021-02755 | Registry Identifier | CTRP (Clinical Trial Reporting Program) | |
| 19-008929 | Other Identifier | Mayo Clinic in Florida |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Prevention (Elasto Gel Therapy Mittens and Foot Wraps) | Experimental | 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Medical Device Usage and Evaluation | Device | Wear Elasto Gel Therapy Mittens and Foot Wraps |
|
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of Chemotherapy Induced Peripheral Neuropathy (CIPN) | Number of subjects to experience chemotherapy induced peripheral neuropathy (CIPN). | During chemotherapy (baseline), after chemotherapy (1 week post baseline), at 3 month follow up |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Pooja Advani, MD | Mayo Clinic | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Mayo Clinic in Florida | Jacksonville | Florida | 32224-9980 | United States |
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| Label | URL |
|---|---|
| Mayo Clinic Clinical Trials | View source |
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This single arm non-randomized study was conducted at Mayo Clinic in Florida. Participants included early breast cancer patients who underwent standard of care chemotherapy and who had Eastern Cooperative Oncology Group (ECOG) performance status 0-2 with no sensory peripheral neuropathy at study entry. Patients with metastatic breast cancer, Raynaud's and peripheral vascular disease, cryoglobulinemia, cold intolerance, prior exposure to neurotoxic or taxane chemotherapy were excluded.
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| ID | Title | Description |
|---|---|---|
| FG000 | Prevention (Elasto Gel Therapy Mittens and Foot Wraps) | 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. Medical Device Usage and Evaluation: Wear Elasto Gel Therapy Mittens and Foot Wraps Questionnaire Administration: Ancillary studies |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | Prevention (Elasto Gel Therapy Mittens and Foot Wraps) | 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. Medical Device Usage and Evaluation: Wear Elasto Gel Therapy Mittens and Foot Wraps Questionnaire Administration: Ancillary studies |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Incidence of Chemotherapy Induced Peripheral Neuropathy (CIPN) | Number of subjects to experience chemotherapy induced peripheral neuropathy (CIPN). | Adults ages 18 and older with diagnosis of breast cancer undergoing 3 months of taxane based chemotherapy [4 cycles of weekly paclitaxel (1 cycle = 3 weeks) or docetaxel every 3 weeks x 4-6 cycles]. | Posted | Count of Participants | Participants | During chemotherapy (baseline), after chemotherapy (1 week post baseline), at 3 month follow up |
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Adverse event (AE) data were collected prior to each cycle of chemo, at the end of each cycle, and 3 months after chemotherapy.
Patients were evaluated for chemotherapy induced peripheral neuropathy (CIPN).
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Prevention (Elasto Gel Therapy Mittens and Foot Wraps) | 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. Medical Device Usage and Evaluation: Wear Elasto Gel Therapy Mittens and Foot Wraps Questionnaire Administration: Ancillary studies |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Neuropathy during chemotherapy (Grade 1) | Nervous system disorders | CTCAE (5.0) | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Pooja P. Advani, MBBS | Mayo Clinic | 904-953-7291 | Advani.Pooja@mayo.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Apr 15, 2022 | Nov 19, 2024 | Prot_SAP_000.pdf |
| ICF | No | No | Yes | Informed Consent Form | Jan 2, 2022 | Nov 19, 2024 | ICF_001.pdf |
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| ID | Term |
|---|---|
| D001943 | Breast Neoplasms |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D001941 | Breast Diseases |
| D012871 | Skin Diseases |
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| ID | Term |
|---|---|
| D010808 | Physical Examination |
| ID | Term |
|---|---|
| D019937 | Diagnostic Techniques and Procedures |
| D003933 | Diagnosis |
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| Questionnaire Administration | Other | Ancillary studies |
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| Participants |
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| Age, Continuous | Median | Standard Deviation | years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Race/Ethnicity, Customized | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| 0 |
| 93 |
| 0 |
| 93 |
| 41 |
| 93 |
| Neuropathy after chemotherapy (Grade 1) | Nervous system disorders | CTCAE (5.0) | Systematic Assessment | 11 patients withdrew prior to the 'neuropathy after chemo' visit |
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| Neuropathy after chemotherapy (Grade 2) | Nervous system disorders | CTCAE (5.0) | Systematic Assessment | 11 patients withdrew prior to the 'neuropathy after chemo' visit |
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| Neuropathy at 3 month follow up (Grade 1) | Nervous system disorders | CTCAE (5.0) | Systematic Assessment | 13 patients withdrew prior to the 'neuropathy at 3-month follow-up' visit |
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| Neuropathy at 3 month follow up (Grade 2) | Nervous system disorders | CTCAE (5.0) | Systematic Assessment | 13 patients withdrew prior to the 'neuropathy at 3-month follow-up' visit |
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| D017437 |
| Skin and Connective Tissue Diseases |