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

Study Overview
=================
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.

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

Conditions
-----------------
Acute Pain

Intervention / Treatment
-----------------
* Other: Quality of life and brief pain inventory


Participation Criteria
=================
Eligibility Criteria
-----------------
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

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Arms and Interventions

| Intervention/Treatment |
| --- |
|Other: Quality of life and brief pain inventory|blood collection and quality of life questionnaires and a pain medication diary|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| 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 | 
| 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 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
pain