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Cryotherapy to Prevent Taxane-induced Sensory Neuropathy of the Hands and Feet

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. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT04256512
Recruitment Status : Recruiting
First Posted : February 5, 2020
Last Update Posted : February 8, 2021
Information provided by (Responsible Party):
Pooja P. Advani, Mayo Clinic

Brief Summary:
Researchers are investigating the effectiveness and tolerability of cryotherapy and to evaluating whether it can prevent or improve taxane-induced sensory peripheral neuropathy.

Condition or disease Intervention/treatment Phase
Breast Cancer Peripheral Neuropathy Chemotherapy-induced Peripheral Neuropathy Device: Elasto Gel® Therapy Mittens and Foot Wraps Not Applicable

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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: Prevention
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 : December 31, 2021
Estimated Study Completion Date : December 31, 2021

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Experimental: Cryotherapy
Subjects diagnosed with breast cancer undergoing 3 months of taxane based chemotherapy will be provided Elasto Gel® Therapy Mittens and Foot Wraps to be worn on both hands and feet at each chemotherapy infusion during their three months of treatment. Subjects will start wearing the mittens and foot wraps 15 minutes prior to each infusion, during the entire infusion, and for 15 minutes after the completion of each infusion. We will assess for peripheral neuropathy, physical functioning, and quality of life prior to initiation of taxane based therapy, immediately after completion of taxane based chemotherapy, and again at 3 months following completion of therapy.
Device: Elasto Gel® Therapy Mittens and Foot Wraps
Cold gel therapy mitten and footwrap
Other Name: Cryotherapy

Primary Outcome Measures :
  1. Number of participants with a lower incidence of peripheral neuropathy, better physical function, and higher quality of life [ Time Frame: 12 months ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 99 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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 x3 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
  • 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

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 identifier (NCT number): NCT04256512

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United States, Florida
Mayo Clinic in Florida Recruiting
Jacksonville, Florida, United States, 32224
Contact: Darilly Torres Santiago    904-953-9974   
Principal Investigator: Pooja P Advani, MBBS, MD         
Sponsors and Collaborators
Mayo Clinic
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Principal Investigator: Pooja P Advani Mayo Clinic
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Responsible Party: Pooja P. Advani, Senior Associate Consultant, Mayo Clinic Identifier: NCT04256512    
Other Study ID Numbers: 19-008929
First Posted: February 5, 2020    Key Record Dates
Last Update Posted: February 8, 2021
Last Verified: February 2021

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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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Peripheral Nervous System Diseases
Neuromuscular Diseases
Nervous System Diseases