Mode
Text Size
Log in / Sign up
N/A N=12 Prevention

Breast/Evaluation of Cryotherapy and TRPA1 Receptors in Chemotherapy Induced Neuropathy

Peripheral Neuropathies

Enrolled (actual)
12
Serious AEs
0.0%
Results posted
Oct 2024
Primary outcome: Primary: Prevention of Peripheral Neuropathy During Taxane Chemotherapy — 7.28 score on a scale

Study Design & Population

Study type
Interventional
Phase
N/A
Interventions
Cryotherapy (Device)
Age
Adult, Older Adult · 18+ yrs
Sex
All
Sponsor
The University of Texas Health Science Center at San Antonio
Primary completion
Sep 2020

Outcome Measures

OutcomeResultp-value
PRIMARY
Prevention of Peripheral Neuropathy During Taxane Chemotherapy
7.28
PRIMARY
Evaluate Safety of Cryotherapy Use

Summary

To determine rate and severity of chemotherapy induced neuropathy in extremities treated with cold gloves and socks versus control extremities

Eligibility Criteria

Inclusion Criteria

  • Histologically confirmed diagnosis of early stage breast cancer (stage I-III).
  • Planned to receive treatment with either adjuvant or neo-adjuvant taxane-based chemotherapy.
  • Age > 18 years. There is no upper age limit for participation in this study.
  • Patients may have received any of the following therapies: surgery, chemotherapy, hormones, biologics, or radiation.
  • Prior chemotherapies are permitted, except with prior treatments with taxanes, vinca alcaloids, gemcitabine, eribulin, ixabepilone, platinum drugs)
  • All patients will have given signed, informed consent prior to registration
  • Patients must have a performance status of ECOG 0 or 1.

Exclusion Criteria

  • Patients must not have received any prior taxane or platinum based chemotherapy.
  • Patients must not have a history of peripheral neuropathy (regardless of cause).
  • Patient must not have a history of Raynaud's disease.
  • Patients with partial or complete limb amputations.
  • Known hypersensitivity to cold
  • Patient cannot be on the following medications: GABA analogues (such as Neurontin, lyrica), tricyclic antidepressants (such as amitriptyline or nortriptyline)
  • As judged by the investigator, severe uncontrolled concurrent medical conditions, psychiatric illness or social condition that would limit compliance with study requirements.
  • Evidence of any significant clinical disorder or laboratory finding that makes it undesirable for the subject to participant in the clinical trial
  • Must not be pregnant or breast feeding
View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT03329131). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.

Back to search