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

Overview

Información sobre este estudio

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.

Elegibilidad para la participación

Los requisitos de elegibilidad de los participantes incluyen la edad, el sexo, el tipo y el estadio de la enfermedad, y los problemas de salud o tratamientos previos. Las pautas difieren de un estudio a otro e identifican quiénes pueden o no pueden participar. No hay garantía de que cada persona elegible que desee participar en un ensayo se inscribirá. Comunícate con el equipo del estudio para analizar la elegibilidad del estudio y la posible participación.

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.

Sedes participantes de Mayo Clinic

Los estatus de los estudios cambian con frecuencia. Comunícate con el equipo del estudio para obtener la información más actualizada acerca de la posibilidad de participar.

Sede de Mayo Clinic Estatus Contacto

Jacksonville, Fla.

Investigador principal de Mayo Clinic

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

Cerrado para la inscripción

Contact information:

Darilly Torres Santiago M.P.H.

(904)953-9974

Torres.Darilly@mayo.edu

More information

Publicaciones

Publications are currently not available

Otros temas en investigación

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CLS-20478971

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