Observational Study of Incidence of Breakthrough Cancer P... | NCT02069067

Studies
Observational Study of Incidence of Breakthrough Cancer Pain and How it is Treated

NCT02069067

Sponsor

National Cancer Institute, Naples

Status

Unknown status

Last Update Posted

Mar 24, 2023Actual

Enrollment

500Estimated

Phase

Not provided

Conditions

Advanced Cancer

Interventions

Not provided

Countries

Italy

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Mar 2023

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Active, not recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Dec 2011

Primary Completion Date

Dec 2023Estimated

Completion Date

Dec 2023Estimated

First Submitted Date

Feb 20, 2014

First Submission Date that Met QC Criteria

Feb 20, 2014

First Posted Date

Feb 21, 2014Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Mar 23, 2023

Last Update Posted Date

Mar 24, 2023Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

The purpose of this study is to describe how often advanced cancer patients experience breakthrough pain (BTcP), and to describe how this pain is treated, and how effective these treatments are.

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

500Estimated

Label	Type	Description	Intervention Names
Advanced cancer patients with pain

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
number of patients who experience BTcP		one year
treatments used to treat BTcP		one year

Secondary Outcomes

Measure	Description	Time Frame
pain intensity	evaluate the relationship between pain intensity, patient characteristics, and clinician choice of pain medication	4 weeks
time to pain relief of BTcP		4 weeks

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Diagnosis of neoplasm in advanced stage
Chronic pain controlled for at least one week with opioids 60 mg / day morphine equivalent
1-6 episodes of BTcP within any of 3 days previous to registration into study
Signed Informed Consent

Exclusion Criteria:

· More than 6 episodes of BTcP within any of 3 days previous to registration into study

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

Not provided

Maximum Age

Not provided

Standard Ages

ChildAdultOlder Adult

Study Population

Patients with advanced cancer and chronic pain being controlled with opiods.

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Arturo Cuomo, M.D.	NCI Naples, Division of Pain Therapy	Principal Investigator
Francesco Perrone, M.D., Ph.D.	NCI Naples, Clinical Trials Unit	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Ospedale San Leonardo		Castellammare di Stabia			Italy
Istituto Nazionale dei Tumori , Unita Terapia Antalgica

Condition Browse Module

MeSH Terms

ID	Term
D010146	Pain
D009437	Neuralgia
D010148	Pain, Intractable
D009369	Neoplasms

Ancestor Terms

ID	Term
D009461	Neurologic Manifestations
D012816	Signs and Symptoms
D013568	Pathological Conditions, Signs and Symptoms
D010523	Peripheral Nervous System Diseases

Browse Leaves

Not provided

Browse Branches

Not provided