Taxane Acute Pain Syndrome (TAPS) in Patients Receiving Taxane Chemotherapy for Breast or Prostate Cancer (TAPSOTT14-06)

Ottawa Hospital Research Institute

Status: Completed

Conditions: Acute Pain

Treatments: Other: Quality of life and brief pain inventory

Study type: Observational

Funder types: Other

Identifiers

NCT02362087

20150011-01H

Details and patient eligibility

About

The purpose of this study is to document what course of action physicians choose for their patients when they develop taxane acute pain syndrome (TAPS) and to identify patients at the greatest risk of TAPS by examining specific human genome markers such as single nucleotide polymorphisms (SNPs) and Copy Number Variations (CNVs) that may explain the genetic (hereditary) component.

Enrollment: 75 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Diagnosed with either invasive breast or prostate cancer (stage I-IV)
• Age ≥18 years
• ECOG performance status ≤2
• Scheduled to receive intravenous taxane-based chemotherapy for either adjuvant or metastatic disease
• Participants need to have ability to complete questionnaires by themselves or with assistance and have the ability to provide informed written consent

Exclusion criteria

• Concurrent use of any agents to try to prevent or treat neuropathy or TAPS, including gabapentin, glutamine, vitamin B6, and vitamin E.
• Pre-existing history of peripheral neuropathy greater than grade 1 NCI CTCAE version 4.0 from any cause (chemotherapy, diabetes, alcohol, toxin, hereditary, etc.) other medical conditions that would make study participation unreasonably hazardous
• Uncontrolled diabetes
• Medical or psychiatric illness that would interfere with patients' ability to complete the diary