Acute PainTAPSOTT14-06NCT02362087
Taxane Acute Pain Syndrome (TAPS) in Patients Receiving Taxane Chemotherapy for Breast or Prostate Cancer
An observational study of Acute Pain, run by Ottawa Hospital Research Institute at 1 site in Canada.
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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Acute Pain
- What is being tested?
- Quality of life and brief pain inventory
- How many people
- 75 participants
- Where
- 1 siteCanada
- Study dates
- Mar 2015to Jul 2016
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients Receiving Taxane Chemotherapy for Breast or Prostate Cancer
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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
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
- Being tested
- Quality of life and brief pain inventory
- Keywords
- pain
- Medical subject headings
- Acute Pain, Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Quality of life and brief pain inventoryOther
blood collection and quality of life questionnaires and a pain medication diary
What is being measured
The primary outcome is the main question the study is designed to answer.
The incidence of TAPS
Participant will be asked prior to each taxane chemotherapy if they experienced TAPS and complete quality of life questionnaires
Measured: Every 21 days over 12 weeks
Secondary outcomes (3)
The intervention used to reduced TAPS severity
The intervention used to reduced TAPS severity including
- Analgesia - pain medication diary
- Exercise
- other
Measured: Every 21 days over 12 weeks
The TAPS associated treatment modification
The TAPS associated treatment modification
- Taxane dose reduction
- Chemotherapy treatment delay
- Taxane discontinuation
- No further treatment pursued ii. Or Switch to non-taxane chemotherapy due to taxane toxicity
Measured: 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)
Measured: At baseline and at one month from the end of Taxane chemotherapy
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Feb 2015 (estimated)
- Study startMar 2015
- Primary completionJul 2016
- Study completionJul 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute PainStudies of the same condition, open and under way.
- More trials run by Ottawa Hospital Research InstituteThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 75 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ottawa Hospital Research Institute
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Ricardo Fernandes, MD, Principal investigator, The Ottawa Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02362087
- Sponsor's protocol ID
- 20150011-01H
- Acronym
- TAPSOTT14-06
- Status last verified
- Sep 2019
- First submitted
- 5 Jan 2015
- Last updated
- 6 Sep 2019
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Sep 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT02362087
- Acronym / sponsor ID
- TAPSOTT14-06 / 20150011-01H
- Conditions
- Acute Pain
- Keywords
- pain
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 75 participants (actual)
- Lead sponsor
- Ottawa Hospital Research InstituteUniversity, hospital or other
- Study start
- Mar 2015
- Primary completion
- Jul 2016 (actual)
- Study completion
- Jul 2016 (actual)
- First posted
- 12 Feb 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients Receiving Taxane Chemotherapy for Breast or Prostate Cancer
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Quality of life and brief pain inventoryblood collection and quality of life questionnaires and a pain medication diary | Other | – |
Primary outcome
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
3 secondary outcomes
The intervention used to reduced TAPS severity
Time frame: Every 21 days over 12 weeks
The TAPS associated treatment modification
Time frame: 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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Sep 2019.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ricardo Fernandes, MD principal investigator
The Ottawa Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Acute Pain, run by Ottawa Hospital Research Institute at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 Sep 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The incidence of TAPS (time frame: Every 21 days over 12 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Sep 2019.