Breast CarcinomaNCT04256512
Cryotherapy for the Prevention of Taxane-Induced Sensory Neuropathy of the Hands and Feet in Breast Cancer Patients
A study testing Medical Device Usage and Evaluation and Questionnaire Administration in people with Breast Carcinoma, run by Mayo Clinic at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Breast Carcinoma
- What is being tested?
- Medical Device Usage and Evaluation and Questionnaire Administration
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 94 participants
- Where
- 1 siteUnited States
- Study dates
- 10 Mar 2020to 18 Jan 2023
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 10Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Mayo Clinic in Florida
Jacksonville, Florida, 32224-9980
About this study
Official title: Cryotherapy to Prevent Taxane-Induced Sensory Neuropathy of the Hands and Feet
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.
Read the detailed description
PRIMARY OBJECTIVE:
- 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.
- Conditions
- Breast Carcinoma
- Being tested
- Medical Device Usage and Evaluation, Questionnaire Administration
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Medical Device Usage and EvaluationDevice
Wear Elasto Gel Therapy Mittens and Foot Wraps
Questionnaire AdministrationOther
Ancillary studies
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Device: Medical Device Usage and Evaluation; Other: Questionnaire Administration |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of Chemotherapy Induced Peripheral Neuropathy (CIPN)
Number of subjects to experience chemotherapy induced peripheral neuropathy (CIPN).
Measured: During chemotherapy (baseline), after chemotherapy (1 week post baseline), at 3 month follow up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Feb 2020
- Study start10 Mar 2020
- Primary completion18 Jan 2023
- Study completion18 Jan 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Breast CarcinomaStudies of the same condition, open and under way.
- More trials run by Mayo ClinicThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 94 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mayo Clinic
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Pooja Advani, MD, Principal investigator, Mayo Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04256512
- Sponsor's protocol ID
- 19-008929
- Other IDs
- NCI-2021-02755, 19-008929
- Status last verified
- Jul 2025
- First submitted
- 31 Jan 2020
- Last updated
- 28 Jul 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 28 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cryotherapy to Prevent Taxane-Induced Sensory Neuropathy of the Hands and Feet
- ClinicalTrials.gov ID
- NCT04256512
- Acronym / sponsor ID
- 19-008929
- Conditions
- Breast Carcinoma
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 94 participants (actual)
- Lead sponsor
- Mayo ClinicUniversity, hospital or other
- Study start
- 10 Mar 2020 (actual)
- Primary completion
- 18 Jan 2023 (actual)
- Study completion
- 18 Jan 2023 (actual)
- First posted
- 5 Feb 2020 (actual)
- Results
- Posted 28 Jul 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- 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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Prevention (Elasto Gel Therapy Mittens and Foot Wraps) | Experimental | Device: Medical Device Usage and Evaluation, Other: Questionnaire AdministrationPatients 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (10 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Medical Device Usage and EvaluationWear Elasto Gel Therapy Mittens and Foot Wraps | Device | Prevention (Elasto Gel Therapy Mittens and Foot Wraps) |
| Questionnaire AdministrationAncillary studies | Other | Prevention (Elasto Gel Therapy Mittens and Foot Wraps) |
Primary outcome
Incidence of Chemotherapy Induced Peripheral Neuropathy (CIPN)
Time frame: During chemotherapy (baseline), after chemotherapy (1 week post baseline), at 3 month follow up
Number of subjects to experience chemotherapy induced peripheral neuropathy (CIPN).
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Jul 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Mayo Clinic Clinical TrialsLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Pooja Advani, MD principal investigator
Mayo Clinic
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Medical Device Usage and Evaluation and Questionnaire Administration in people with Breast Carcinoma, run by Mayo Clinic at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 28 Jul 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of Chemotherapy Induced Peripheral Neuropathy (CIPN) (time frame: During chemotherapy (baseline), after chemotherapy (1 week post baseline), at 3 month follow up). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Jul 2025.