A Consensus on Opioid Prescription for Oncologic Patients in Latin America - A DELPHI Study.

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.

Study Overview

• Status: Enrolling by invitation
• Conditions: Cancer Patients; Cancer-related Pain

• Study Type: Observational
• Enrollment (Anticipated): 20

Contacts and Locations

Study Locations

• Brazil
  • SP
    • Sao Paulo, SP, Brazil, 05409-010
      • Felipe Porto Rangel

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 30 years to 70 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

• Sampling Method: Non-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.

Description

Inclusion Criteria:

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

Exclusion Criteria:

• Surveys not answered.

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Survey answers	answers of the survey sent	Up to 3 (three) months

Collaborators and Investigators

• Sponsor: Instituto do Cancer do Estado de São Paulo
• Investigators: Principal Investigator: Felipe P Rangel, PhD, MD Anderson; Study Director: Juan P Cata, PhD, M.D. Anderson Cancer Center

Study record dates

Study Major Dates

• Study Start (Anticipated): April 15, 2021
• Primary Completion (Anticipated): May 30, 2021
• Study Completion (Anticipated): June 30, 2021

Study Registration Dates

• First Submitted: April 9, 2021
• First Submitted That Met QC Criteria: April 13, 2021
• First Posted (Actual): April 14, 2021

Study Record Updates

• Last Update Posted (Actual): April 14, 2021
• Last Update Submitted That Met QC Criteria: April 13, 2021
• Last Verified: April 1, 2021

More Information

Terms related to this study

• Keywords: opioids; opioid abuse; cancer-related pain; end-of-life
• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Cancer Pain
• Other Study ID Numbers: 08042021

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: No IPD will be shared. The data collected will be summarized and a consensus of the answers of all participants will reported.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No