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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

75 participants

Study Classification

OBSERVATIONAL

Study Start Date

2015-03-31

Study Completion Date

2016-07-31

Brief Summary

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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.

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Detailed Description

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Conditions

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Acute Pain

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Interventions

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Quality of life and brief pain inventory

blood collection and quality of life questionnaires and a pain medication diary

Intervention Type OTHER

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No