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N/A Completed N=12 Prevention

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

Peripheral Neuropathies
Source: ClinicalTrials.gov NCT03329131 ↗
Enrolled (actual)
12
Serious AEs
0.0%
Results posted
Oct 2024
Primary outcomePrimary: Prevention of Peripheral Neuropathy During Taxane Chemotherapy — 7.28 score on a scale

Summary

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

Outcome Measures

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

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. Informational only — not medical advice.

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