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

NCT02362087 | Completed

• 1 other identifier: 20150011-01H
• Study Type: observational
• Target: 75
• Locations: 1 country
• Sites: 1

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.

Conditions

Acute Pain

Keywords

pain

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• The intervention used to reduced TAPS severity

  Every 21 days over 12 weeks

• The TAPS associated treatment modification

  Every 21 days over 12 weeks

• Collection of whole blood and archived tissue for future SNP analysis

  At baseline and at one month from the end of Taxane chemotherapy

Interventions

Quality of life and brief pain inventory OTHER

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

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Patients Receiving Taxane Chemotherapy for Breast or Prostate Cancer

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Ottawa Hospital Research Institute: lead

Study Sites (1)

Ricardo Fernandes

Ottawa, Ontario, K1H 8L6, Canada

Location

Biospecimen

Retention: SAMPLES WITH DNA

Serum, plasma and buffy coat will be collected and archived tissure.

MeSH Terms

Conditions

Acute Pain; Pain

Interventions

Quality of Life

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Health Status; Demography; Epidemiologic Measurements; Public Health; Environment and Public Health

Study Officials

• Ricardo Fernandes, MD

  The Ottawa Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 5, 2015
• First Posted: February 12, 2015
• Study Start: March 1, 2015
• Primary Completion: July 1, 2016
• Study Completion: July 1, 2016
• Last Updated: September 6, 2019

Record last verified: 2019-09

Locations

CA (1)