Cancer PatientsNCT04844788
A Consensus on Opioid Prescription for Oncologic Patients in Latin America - A DELPHI Study.
An observational study of Cancer Patients and Cancer-related Pain, run by Instituto do Cancer do Estado de São Paulo at 1 site in Brazil.
Trial 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. Read more about this study
- Who is it for?
- Ages 30 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Cancer Patients, Cancer-related Pain
- How many people
- 20 participants
- Where
- 1 siteBrazil
- Study dates
- 15 Apr 2021to 30 Jun 2021
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 30 to 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
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.
Who may be able to join
- Head of anesthesia, Pain management and palliative care departments of cancer hospitals in Latin America.
Who cannot join
- Surveys not answered.
Trial locations and contacts
1 site in 1 country.
About this 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.
- Conditions
- Cancer Patients, Cancer-related Pain
- Keywords
- opioids, cancer-related pain, end-of-life, opioid abuse
- Medical subject headings
- Cancer Pain, Death, Opioid-Related Disorders
What is being measured
The primary outcome is the main question the study is designed to answer.
Survey answers
answers of the survey sent
Measured: Up to 3 (three) months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Apr 2021
- Study start15 Apr 2021 (estimated)
- Primary completion30 May 2021 (estimated)
- Study completion30 Jun 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cancer PatientsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Cross-sectional
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Instituto do Cancer do Estado de São Paulo
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Felipe Porto Rangel, Hospital Sirio-Libanes
- Investigators
- Felipe P Rangel, PhD, Principal investigator, MD AndersonJuan P Cata, PhD, Study director, M.D. Anderson Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04844788
- Sponsor's protocol ID
- 08042021
- Status last verified
- Apr 2021
- First submitted
- 9 Apr 2021
- Last updated
- 14 Apr 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: No IPD will be shared. The data collected will be summarized and a consensus of the answers of all participants will reported.
Study at a glance
From the registry record, last updated by the sponsor on 14 Apr 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Consensus on Opioid Prescription for Oncologic Patients in Latin America - A DELPHI Study.
- ClinicalTrials.gov ID
- NCT04844788
- Acronym / sponsor ID
- 08042021
- Conditions
- Cancer Patients, Cancer-related Pain
- Keywords
- opioids, cancer-related pain, end-of-life, opioid abuse
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Instituto do Cancer do Estado de São PauloUniversity, hospital or other
- Study start
- 15 Apr 2021 (estimated)
- Primary completion
- 30 May 2021 (estimated)
- Study completion
- 30 Jun 2021 (estimated)
- First posted
- 14 Apr 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Other
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 30 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (1 listed)
- Head of anesthesia, Pain management and palliative care departments of cancer hospitals in Latin America.
Key exclusion criteria (1 listed)
- Surveys not answered.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Survey answers
Time frame: Up to 3 (three) months
answers of the survey sent
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Apr 2021.
- Individual participant dataSharing planned: No. No IPD will be shared. The data collected will be summarized and a consensus of the answers of all participants will reported.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Felipe P Rangel, PhD principal investigator
MD Anderson
Juan P Cata, PhD study director
M.D. Anderson Cancer Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cancer Patients and Cancer-related Pain, run by Instituto do Cancer do Estado de São Paulo at 1 site in Brazil.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 14 Apr 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Brazil. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Survey answers (time frame: Up to 3 (three) months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Apr 2021.