Prevention of Taxane-associated Acute Pain Syndrome With Etoricoxib

January 29, 2022 updated by: Kun Wang, Guangdong Provincial People's Hospital

Prevention of Taxane-associated Acute Pain Syndrome With Etoricoxib for Breast Cancer Patients: A Phase II Randomized Trial

A phase II randomized clinical trial was conducted to determine whether etoricoxib could prevent or ameliorate the incidence and/or severity of docetaxel-induced acute pain syndrome. We also aimed to determine if there are any improvement of the late-onset peripheral neuropathy as well as quality of life with prophylactic etoricoxib for breast cancer patients who receive docetaxel chemotherapy.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

Docetaxel plays a key role in reducing the recurrence of early-stage breast cancer as well as improving survival outcomes of advanced breast cancer patients, but it causes a variety of adverse events, including myalgia and arthralgia, peripheral neuropathy, febrile neutropenia, and hypersensitivity reactions and so on. The myalgia and arthralgia induced by docetaxel, which have been together referred to as taxane-associated acute pain syndrome (T-APS), were reported to occur in 3.6% to 70% of patients, and the symptoms usually occurred 24-48 hours after docetaxel infusion and lasted for 3-5 days. Previous studies found that patients who experienced myalgia and arthralgia due to docetaxel administration were more likely to have chronic peripheral neuropathy, which supported that T-APS could be a form of neurologic toxicity. T-APS may significantly influence patients' sleep and daily life, and even caused discontinuation of chemotherapy. Therefore, it is clinically meaningful to explore some prophylactic drugs for the T-APS. Previous studies had used glutamine, corticosteroids, Shakuyaku-Kanzo-To (a Japanese herb), and gabapentin to prevent paclitaxel-induced myalgia and arthralgia, but failed to provide enough evidence for clinical practice. Etoricoxib, a selective COX-2 inhibitor, is a nonsteroidal anti-inflammatory drug (NSAID) that has showed comparable efficacy in acute and chronic pain, with fewer gastrointestinal (GI) adverse events compared with traditional NSAIDs. Therefore, we conducted a phase II randomized clinical trial to investigate whether etoricoxib could prevent or ameliorate the incidence and/or severity of docetaxel-induced acute pain syndrome. We also aimed to determine if there are any improvement of the late-onset peripheral neuropathy as well as quality of life with prophylactic etoricoxib for breast cancer patients who receive docetaxel chemotherapy.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
144

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Guangdong
      • Guangzhou, Guangdong, China, 510080
        • Guangdong General Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

14 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

Inclusion Criteria:

  • Signed informed consent
  • Age ≥18 years
  • Stage I-III breast cancer
  • ECOG 0-2
  • Received docetaxel-containing chemotherapy

Exclusion Criteria:

  • Existed any chronic pain or peripheral neuropathy
  • Prior history of gastrointestinal bleeding or ulcer
  • Long-term history of receiving oral corticoids, nonsteroid anti-inflammatory drugs (NSAIDs) or anti-histamines
  • Allergies to NSAIDs or aspirin
  • Blood creatinine level exceeds 1.5 times of the upper limit of normal range

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Etoricoxib
Prophylactic etoricoxib (60 mg) was administered orally at each course of docetaxel-containing chemotherapy, which started from the day of chemotherapy and was performed once per day for 8 days (day 1-8).
Drug: Etoricoxib
Etoricoxib 60 Mg Oral Tablet
No Intervention: Control
No prophylactic regimen was given.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
overall incidence of taxane-associated acute pain syndrome across all cycles of chemotherapy
Time Frame: 6 months
Total incidence of myalgia and arthralgia of patients across all cycles of docetaxel chemotherapy
6 months

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
incidence of taxane-associated acute pain syndrome at each cycle
Time Frame: 6 months
Incidence of myalgia and arthralgia of patients at each cycle of docetaxel chemotherapy
6 months
severity of taxane-associated acute pain syndrome at each cycle
Time Frame: 6 months
Severity of myalgia and arthralgia of patients at each cycle of docetaxel chemotherapy; the severity of pain was evaluated on a scale of 0 (no pain) to 10 (pain as bad as you can imagine).
6 months
duration of taxane-associated acute pain syndrome at each cycle
Time Frame: 6 months
Duration of myalgia and arthralgia of patients at each cycle of docetaxel chemotherapy; the duration of pain was counted by days.
6 months
incidence of severe taxane-associated acute pain syndrome by cycle and across all cycles
Time Frame: 6 months
incidence of severe myalgia and arthralgia (score, defined as greater than 5 on a scale from 0 to 10) of patients during the period of docetaxel chemotherapy by cycle and across all cycles
6 months
Functional Assessment of Cancer Therapy-Breast (FACT-B) subscale at each cycle
Time Frame: 6 months
Functional Assessment of Cancer Therapy-Breast（FACT-B）subscale during the period of docetaxel chemotherapy was assessed; the scores range from 0 to 144, higher scores mean a better outcome (higher quality of life)
6 months
incidence of peripheral neuropathy after all cycles of chemotherapy
Time Frame: 6 months
Functional Assessment of Cancer Treatment Neurotoxicity (FACT-Ntx) subscale (FACT-Ntx score <44), Eastern Cooperative Oncology Group neuropathy scale (ENS) subscale and EMG were performed at 3 months after the completion of chemotherapy.
6 months
adverse events
Time Frame: 6 months
Assessment of adverse events was based on the National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 grading scale.
6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Guangdong Provincial People's Hospital

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Kun Wang, MD, Guangdong Provincial People's Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
March 1, 2020

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
April 22, 2021

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
June 28, 2021

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
September 13, 2020

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 21, 2020

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
September 25, 2020

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
February 14, 2022

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 29, 2022

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
January 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 20190516

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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