Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-26 @ 10:43 PM
Ignite Modification Date:
2025-12-26 @ 10:43 PM
NCT ID:
NCT04256512
Eligibility Criteria:
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 in the last 10 years
* 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
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT04256512
Study Brief:
Protocol Section:
NCT04256512