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

Completed

• Conditions: Acute Pain

• Registration Number: NCT02362087
• Lead Sponsor: Ottawa Hospital Research Institute

Brief Summary

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.

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study First Submitted: 2015-01-05
• Study First Submitted QC: 2015-02-08
• Study First Posted: 2015-02-12
• Study Start: 2015-03
• Primary Completion: 2016-07
• Study Completion: 2016-07
• Status Verified: 2019-09
• Last Update Submitted: 2019-09-03
• Last Update Posted: 2019-09-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 75

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

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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

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
The incidence of TAPS	Every 21 days over 12 weeks	Participant will be asked prior to each taxane chemotherapy if they experienced TAPS and complete quality of life questionnaires

Secondary Outcome Measures

Name	Time	Method
The intervention used to reduced TAPS severity	Every 21 days over 12 weeks	The intervention used to reduced TAPS severity including; 1. Analgesia - pain medication diary; 2. Exercise; 3. other
The TAPS associated treatment modification	Every 21 days over 12 weeks	The TAPS associated treatment modification; 1. Taxane dose reduction; 2. Chemotherapy treatment delay; 3. Taxane discontinuation; i. No further treatment pursued ii. Or Switch to non-taxane chemotherapy due to taxane toxicity
Collection of whole blood and archived tissue for future SNP analysis	At baseline and at one month from the end of Taxane chemotherapy	Profiling of SNPs will aid to understand the genetic basis for TAPS and outcomes. We will also collect serum and plasma for profiling serum metabolites, drug metabolites and correlate with genotypes (SNPs)

Trial Locations

Locations (1)

Ricardo Fernandes; 🇨🇦 Ottawa, Ontario, Canada