NCT04565600

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
144

participants targeted

Target at P75+ for phase_2

Timeline
Completed

Started Mar 2020

Shorter than P25 for phase_2

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2020

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

September 13, 2020

Completed
12 days until next milestone

First Posted

Study publicly available on registry

September 25, 2020

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 22, 2021

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 28, 2021

Completed
Last Updated

February 14, 2022

Status Verified

January 1, 2022

Enrollment Period

1.1 years

First QC Date

September 13, 2020

Last Update Submit

January 29, 2022

Conditions

Pain Syndrome

Keywords

Breast CancerDocetaxelEtoricoxibAcute pain syndromePeripheral neuropathy

Outcome Measures

Primary Outcomes (1)

  • overall incidence of taxane-associated acute pain syndrome across all cycles of chemotherapy

    Total incidence of myalgia and arthralgia of patients across all cycles of docetaxel chemotherapy

    6 months

Secondary Outcomes (7)

  • incidence of taxane-associated acute pain syndrome at each cycle

    6 months

  • severity of taxane-associated acute pain syndrome at each cycle

    6 months

  • duration of taxane-associated acute pain syndrome at each cycle

    6 months

  • incidence of severe taxane-associated acute pain syndrome by cycle and across all cycles

    6 months

  • Functional Assessment of Cancer Therapy-Breast (FACT-B) subscale at each cycle

    6 months

  • +2 more secondary outcomes

Study Arms (2)

Etoricoxib

EXPERIMENTAL

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

Control

NO INTERVENTION

No prophylactic regimen was given.

Interventions

EtoricoxibDRUG

Etoricoxib 60 Mg Oral Tablet

Etoricoxib

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Guangdong General Hospital

Guangzhou, Guangdong, 510080, China

Location

Related Publications (1)

  • Zhang J, Gao HF, Yang C, Zhu T, Ji F, Yang M, Zhang L, Li J, Cheng M, Zhang T, Shen B, Chen Y, Wang K. Prevention of taxane-associated acute pain syndrome with etoricoxib for patients with breast cancer: A phase II randomised trial. Eur J Cancer. 2022 Aug;171:150-160. doi: 10.1016/j.ejca.2022.05.019. Epub 2022 Jun 17.

    PMID: 35724467DERIVED

MeSH Terms

Conditions

Somatoform DisordersBreast NeoplasmsPeripheral Nervous System Diseases

Interventions

Etoricoxib

Condition Hierarchy (Ancestors)

Mental DisordersNeoplasms by SiteNeoplasmsBreast DiseasesSkin DiseasesSkin and Connective Tissue DiseasesNeuromuscular DiseasesNervous System Diseases

Intervention Hierarchy (Ancestors)

SulfonesSulfur CompoundsOrganic ChemicalsPyridinesHeterocyclic Compounds, 1-RingHeterocyclic Compounds

Study Officials

  • Kun Wang, MD

    Guangdong Provincial People's Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

September 13, 2020

First Posted

September 25, 2020

Study Start

March 1, 2020

Primary Completion

April 22, 2021

Study Completion

June 28, 2021

Last Updated

February 14, 2022

Record last verified: 2022-01

Locations

CN(1)