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Completed

NCT Number: NCT02362087

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.

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Key information

Conditions

Acute Pain Neurologic Manifestations Pain Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Ricardo Fernandes

Ottawa, Ontario, K1H 8L6, Canada

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Quality of life and brief pain inventory

Other

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

Primary outcomes

  1. 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

Secondary outcomes

  1. The intervention used to reduced TAPS severity

    Time frame: Every 21 days over 12 weeks

    The intervention used to reduced TAPS severity including

    • Analgesia - pain medication diary
    • Exercise
    • other

  2. The TAPS associated treatment modification

    Time frame: Every 21 days over 12 weeks

    The TAPS associated treatment modification

    • Taxane dose reduction
    • Chemotherapy treatment delay
    • Taxane discontinuation

    i. No further treatment pursued ii. Or Switch to non-taxane chemotherapy due to taxane toxicity

  3. 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)

Sponsors and collaborators

Lead sponsor

Ottawa Hospital Research Institute

Other

Registry information

Official study title

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

Acronym: TAPSOTT14-06

Important dates

Study start
2015
Primary completion
2016
Study completion
2016
First posted
Feb 12, 2015
Registry last updated
Sep 6, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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