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

Acute Pain Clinical Trial

— TAPSOTT14-06  

Official 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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02362087
• Other study ID #: 20150011-01H
• Status: Completed
• Start date: March 2015
• Est. completion date: July 2016

Study information

• Verified date: September 2019
• Source: Ottawa Hospital Research Institute
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 75
• Est. completion date: July 2016
• Est. primary completion date: July 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Acute Pain

Intervention

Other:
• Quality of life and brief pain inventory
blood collection and quality of life questionnaires and a pain medication diary

Locations

Country	Name	City	State
Canada	Ricardo Fernandes	Ottawa	Ontario

Sponsors (1)

Lead Sponsor	Collaborator
Ottawa Hospital Research Institute

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The incidence of TAPS	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	The intervention used to reduced TAPS severity	The intervention used to reduced TAPS severity including; Analgesia - pain medication diary; Exercise; other	Every 21 days over 12 weeks
Secondary	The TAPS associated treatment modification	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	Every 21 days over 12 weeks
Secondary	Collection of whole blood and archived tissue for future SNP analysis	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