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Cryotherapy for the Prevention of Taxane-Induced Sensory Neuropathy of the Hands and Feet in Breast Cancer Patients

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04256512
Recruitment Status : Active, not recruiting
First Posted : February 5, 2020
Last Update Posted : February 14, 2023
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Mayo Clinic

Study Description
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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.

Condition or disease Intervention/treatment Phase
Breast Carcinoma Device: Medical Device Usage and Evaluation Other: Questionnaire Administration Not Applicable

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.

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 80 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Official Title: Cryotherapy to Prevent Taxane-Induced Sensory Neuropathy of the Hands and Feet
Actual Study Start Date : January 23, 2020
Estimated Primary Completion Date : May 15, 2023
Estimated Study Completion Date : December 31, 2024

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Foot Health

Arms and Interventions
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Arm Intervention/treatment
Experimental: 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.
 Device: Medical Device Usage and Evaluation
Wear Elasto Gel Therapy Mittens and Foot Wraps

Other: Questionnaire Administration
Ancillary studies


Outcome Measures
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Primary Outcome Measures :
  1. Peripheral neuropathy (PN) [ Time Frame: Up to 3 months post chemotherapy ]
    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.


Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04256512


Locations
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United States, Florida
Mayo Clinic in Florida
Jacksonville, Florida, United States, 32224-9980
Sponsors and Collaborators
Mayo Clinic
National Cancer Institute (NCI)
Investigators
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Principal Investigator: Pooja Advani Mayo Clinic
More Information
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Responsible Party: Mayo Clinic
ClinicalTrials.gov Identifier: NCT04256512    
Other Study ID Numbers: 19-008929
NCI-2021-02755 ( Registry Identifier: CTRP (Clinical Trial Reporting Program) )
19-008929 ( Other Identifier: Mayo Clinic in Florida )
First Posted: February 5, 2020    Key Record Dates
Last Update Posted: February 14, 2023
Last Verified: February 2023

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Additional relevant MeSH terms:
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Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases