NCT04844788

Brief Summary

As seen worldwide, cancer incidence is increasing in Latin America achieving an amount of 1.3 million new cases annually.1 In addition, it is expected that up to 70% of patients with cancer will experience pain2, one of the most distressing symptoms in patients with advanced cancer. And despite of advances in cancer therapies, opioids remain the mainstay treatment of cancer-related moderate-to-severe and end-of-life pain.3 However, concerns regarding opioid prescriptions have emerged for reasons like the risk of misuse and the possibility of cancer progression. In the last decades, an increase in consumption of opioids as well as in opioids-related deaths generating the so called 'opioid crisis'. This rise is mainly due to abuse / addiction of opioids. Consequently, oncologic patients are at risk for abuse, as well as for aberrant use, which can complicate the course of cancer treatment.4 5 Another feature of opioids use in cancer patients is that it may contribute to disease progression. Experimental studies suggest that opioids can may lead to immunosuppression and tumor progression or recurrence.6-8 On the other hand, retrospective analysis of clinical data shows conflicting results and trials are lacking.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
20

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Apr 2021

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

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

April 9, 2021

Completed
5 days until next milestone

First Posted

Study publicly available on registry

April 14, 2021

Completed
1 day until next milestone

Study Start

First participant enrolled

April 15, 2021

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 30, 2021

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2021

Completed
Last Updated

April 14, 2021

Status Verified

April 1, 2021

Enrollment Period

2 months

First QC Date

April 9, 2021

Last Update Submit

April 13, 2021

Conditions

Keywords

opioidscancer-related painend-of-lifeopioid abuse

Outcome Measures

Primary Outcomes (1)

  • Survey answers

    answers of the survey sent

    Up to 3 (three) months

Eligibility Criteria

Age30 Years - 70 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

The experts assessed in this study will be the heads of anesthesia, pain management and palliative care of leading cancer hospitals of Latin America countries. For each Latin America country will be assessed 3 experts maximum.

You may qualify if:

  • Head of anesthesia, Pain management and palliative care departments of cancer hospitals in Latin America.

You may not qualify if:

  • Surveys not answered.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Felipe Porto Rangel

São Paulo, São Paulo, 05409-010, Brazil

Location

MeSH Terms

Conditions

Cancer PainDeathOpioid-Related Disorders

Condition Hierarchy (Ancestors)

PainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and SymptomsPathologic ProcessesNarcotic-Related DisordersSubstance-Related DisordersChemically-Induced DisordersMental Disorders

Study Officials

  • Felipe P Rangel, PhD

    MD Anderson

    PRINCIPAL INVESTIGATOR
  • Juan P Cata, PhD

    M.D. Anderson Cancer Center

    STUDY DIRECTOR

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Dr

Study Record Dates

First Submitted

April 9, 2021

First Posted

April 14, 2021

Study Start

April 15, 2021

Primary Completion

May 30, 2021

Study Completion

June 30, 2021

Last Updated

April 14, 2021

Record last verified: 2021-04

Data Sharing

IPD Sharing
Will not share

No IPD will be shared. The data collected will be summarized and a consensus of the answers of all participants will reported.

Locations