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

September 3, 2019 updated by: Ottawa Hospital Research Institute

A Multi-Centre Study to Investigate the Natural History of Taxane Acute Pain Syndrome (TAPS) in Patients Receiving Taxane Chemotherapy for Breast or Prostate Cancer

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

75

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
    • Ontario
      • Ottawa, Ontario, Canada, K1H 8L6
        • Ricardo Fernandes

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

Patients Receiving Taxane Chemotherapy for Breast or Prostate Cancer

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The incidence of TAPS
Time Frame: 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
Every 21 days over 12 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The intervention used to reduced TAPS severity
Time Frame: Every 21 days over 12 weeks

The intervention used to reduced TAPS severity including

  1. Analgesia - pain medication diary
  2. Exercise
  3. other
Every 21 days over 12 weeks
The TAPS associated treatment modification
Time Frame: 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
Every 21 days over 12 weeks
Collection of whole blood and archived tissue for future SNP analysis
Time Frame: 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)
At baseline and at one month from the end of Taxane chemotherapy

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Ottawa Hospital Research Institute

Investigators

  • Principal Investigator: Ricardo Fernandes, MD, The Ottawa Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2015

Primary Completion (Actual)

July 1, 2016

Study Completion (Actual)

July 1, 2016

Study Registration Dates

First Submitted

January 5, 2015

First Submitted That Met QC Criteria

February 8, 2015

First Posted (Estimate)

February 12, 2015

Study Record Updates

Last Update Posted (Actual)

September 6, 2019

Last Update Submitted That Met QC Criteria

September 3, 2019

Last Verified

September 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 20150011-01H

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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