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

Overview

About this study

The purpose of this study is to evaluate the effectiveness and tolerability of cryotherapy (cold therapy) in the form of Elasto Gel® frozen mittens and foot wraps to determine whether or not they can prevent or ameliorate taxane-induced sensory peripheral neuropathy. The hypothesis of our pilot study is that patients receiving cryotherapy during infusion of taxane therapy will have lower incidence of peripheral neuropathy, better physical function, and higher quality of life as compared to patients previously reported in literature.

Participation eligibility

Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. There is no guarantee that every individual who qualifies and wants to participate in a trial will be enrolled. Contact the study team to discuss study eligibility and potential participation.

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.
  • 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.

Participating Mayo Clinic locations

Study statuses change often. Please contact the study team for the most up-to-date information regarding possible participation.

Mayo Clinic Location Status Contact

Jacksonville, Fla.

Mayo Clinic principal investigator

Pooja Advani, M.B.B.S., M.D.

Open for enrollment

Contact information:

Darilly Torres Santiago M.P.H.

(904)953-9974

Torres.Darilly@mayo.edu

More information

Publications

Publications are currently not available

Study Results Summary

Not yet available

Supplemental Study Information

Not yet available

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CLS-20478971

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