NCT04314310

Brief Summary

breast cancer surgery is associated with a high incidence of persistant postsurgical pain (PPSP). The aim of the study was to evluate the impact of intravenous Tenoxicam on acute and PPSP, analgesic requirements and gastrointestinal recovery in patients undergoing surgery for breast cancer.

Trial Health

35
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
30

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Mar 2020

Longer than P75 for not_applicable

Status
unknown

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

First Submitted

Initial submission to the registry

March 17, 2020

Completed
2 days until next milestone

First Posted

Study publicly available on registry

March 19, 2020

Completed
4 days until next milestone

Study Start

First participant enrolled

March 23, 2020

Completed
2.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2022

Completed
3 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2025

Completed
Last Updated

March 19, 2020

Status Verified

March 1, 2020

Enrollment Period

2.8 years

First QC Date

March 17, 2020

Last Update Submit

March 17, 2020

Conditions

Gastrointestinal Recovery

Keywords

orocecal transmit time, flatus

Outcome Measures

Primary Outcomes (1)

  • morphine consumption

    morphine consumption after breast cancer surgery

    until postoperative day7

Secondary Outcomes (1)

  • orocecal transmit time,

    preoperative and postoperative day 1

Study Arms (2)

Tenoxicam

ACTIVE COMPARATOR

nonsteroidal anti-inflammatory drug (NSAID)

Drug: Tenoxicam

placebo

PLACEBO COMPARATOR

equal volume of normal saline

Drug: Placebo

Interventions

TenoxicamDRUG

nonsteroidal anti-inflammatory drug (NSAID)

Tenoxicam
PlaceboDRUG

equal volume of normal saline

placebo

Eligibility Criteria

Age40 Years - 60 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • ASA I to II Breast cancer patients Mastectomy or wide local excision + axillary note dissection

You may not qualify if:

  • Preexisting malignancy Chronic infection Previous pain condition Diabetes Thyroid disorder Severe cardiac, renal or hepatic disease Previous breast surgery Psychiatric illness Neurological disease Contraindication for tenoxicam or morphine use

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Flatulence

Interventions

tenoxicam

Condition Hierarchy (Ancestors)

Signs and Symptoms, DigestiveSigns and SymptomsPathological Conditions, Signs and Symptoms

Central Study Contacts

Ya-Jung Cheng, MD,PhD

CONTACT

chengyj@ntu.edu.tw

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, CARE PROVIDER
Masking Details
care provider and participant were masked
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: treatment: Tenoxicam; control: placebo
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 17, 2020

First Posted

March 19, 2020

Study Start

March 23, 2020

Primary Completion

December 31, 2022

Study Completion

December 31, 2025

Last Updated

March 19, 2020

Record last verified: 2020-03

Data Sharing

IPD Sharing
Will not share

due to ethical concern