NCT02514252

Brief Summary

The goal of this clinical research study is to learn if an investigational dose of fentanyl sublingual spray (FSS) can help to control pain in patients with advanced cancer when given in an outpatient and inpatient setting.

Trial Health

57
Monitor

Trial Health Score

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

Enrollment
6

participants targeted

Target at below P25 for phase_2

Timeline
Completed

Started Feb 2016

Typical duration for phase_2

Geographic Reach
1 country

1 active site

Status
terminated

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

July 31, 2015

Completed
3 days until next milestone

First Posted

Study publicly available on registry

August 3, 2015

Completed
6 months until next milestone

Study Start

First participant enrolled

February 2, 2016

Completed
3.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 4, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 4, 2019

Completed
1.5 years until next milestone

Results Posted

Study results publicly available

May 18, 2021

Completed
Last Updated

May 18, 2021

Status Verified

April 1, 2021

Enrollment Period

3.8 years

First QC Date

July 31, 2015

Results QC Date

April 27, 2021

Last Update Submit

April 27, 2021

Conditions

Advanced Cancers

Keywords

Advanced CancersMetastaticRecurrent cancerIncurable cancerFentanyl sublingual sprayFSSQuestionnairesSurveysMental ability testsPhone callsStudy diaryPain control

Outcome Measures

Primary Outcomes (1)

  • Effective Dose of Fentanyl Sublingual Spray (FSS)

    To determine the effective dose of Fentanyl sublingual spray in the management of breakthrough pain (4 episodes) in hospitalized patients with advanced cancer receiving continuous opioid infusion in which the first starting dose would be proportional to the patients Morphine Equivalent Daily Dose. It will use Alberta Breakthrough Pain assessment tool with 15 questions.

    Up to 1 months after discharge from the hospital

Secondary Outcomes (2)

  • Difference Between Intravenous Opioid and Fentanyl Sublingual Spray

    Up to 1 month after discharge from the hospital

  • Safety, Tolerability, Pattern of Use and Efficacy

    Up to 1 month after discharge from the hospital

Study Arms (1)

Fentanyl Sublingual Spray (FSS)

EXPERIMENTAL

Hospitalized participants asked to complete a number of surveys at baseline. Participants then receive one single dose of intravenous opioid rescue for their first episode of breakthrough pain, and then receive up to 4 doses of FSS for subsequent episodes of breakthrough pain. Initial FSS starting dose is proportional to the patient's morphine equivalent daily dose (MEDD). Symptom questionnaire completed at baseline and after last dose of FSS while hospitalized. Mental ability tests given while hospitalized 30 minutes after first dose of current pain medication, and 30 minutes after each FSS dose. At the time of discharge, if FSS was helpful in controlling participant's pain, they are then able to continue with FSS use for 1 month. Participants given study diary to document pain level, how many times FSS used, and any side effects experienced each day.

Drug: Fentanyl Sublingual Spray (FSS)Behavioral: QuestionnairesBehavioral: Mental Ability TestsBehavioral: Study Diary

Interventions

Fentanyl Sublingual Spray (FSS)DRUG

Stage 1: First Pain Episode - Single dose of breakthrough opioid given from existing PCA pump equivalent to 10% of their MEDD. Second Pain Episode - Single dose of FSS equivalent to 16-32% of MEDD. If not effective at 30 minutes, participant repeats same dose one more time (with a cap of 1600 mcg total; i.e. dose given 30 minutes ago + dose now = 1600 mcg maximum. Third Pain Episode (at least 4 hours after second episode) - Participant required 2 breakthrough FSS doses for the last episode of breakthrough pain, or if the effective dose has not been identified, he/she will double the last administered dose. If breakthrough pain not effective at 30 minutes, participant repeats same dose one more time (with a cap of 1600 mcg total; i.e. dose given 30 minutes ago + dose now = 1600 mcg maximum). Stage 2: If FSS successful in hospital, upon discharge, FSS used as first choice of pain medication instead of oral pain medication for pain for up to 4 weeks.

Also known as: Fentanyl SL Spray
Fentanyl Sublingual Spray (FSS)
QuestionnairesBEHAVIORAL

Symptom questionnaire completed at baseline and after last dose of FSS while hospitalized. After Day 28, questionnaire completed over the phone about participant's opinion of research study.

Also known as: Surveys
Fentanyl Sublingual Spray (FSS)
Mental Ability TestsBEHAVIORAL

Mental ability tests given while hospitalized 30 minutes after first dose of current pain medication, and 30 minutes after each FSS dose.

Fentanyl Sublingual Spray (FSS)
Study DiaryBEHAVIORAL

Participants given study diary to document pain level, how many times FSS used, and any side effects experienced each day.

Fentanyl Sublingual Spray (FSS)

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients with advanced cancer (locally advanced, metastatic, recurrent and/or incurable cancer).
  • Opioid tolerant, taking daily doses of strong opioid pain medication in the past 1 week.
  • On strong opioid intravenous continuous infusion MEDD \>=70 mg/day at the time of enrollment.
  • Inpatient at MD Anderson seen by palliative care team.
  • Background cancer pain that is \<=3/10 in the last 24 hours.
  • Breakthrough cancer pain that is \>=4/10 in the last 24 hours.
  • Stable pain control defined as rescue doses \<=6 in last 24 hours.
  • Age \>=18
  • Ability to communicate in English

You may not qualify if:

  • Memorial Delirium Assessment Scale \>13/30
  • History of opioid abuse
  • CAGE positivity (\>=2/4)
  • Allergy to fentanyl
  • Grade 2 or higher oral mucositis
  • Unable/unwilling to sign consent

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Texas MD Anderson Cancer Center

Houston, Texas, 77030, United States

Location

Related Links

MeSH Terms

Conditions

Neoplasm MetastasisRecurrenceAgnosia

Interventions

Surveys and Questionnaires

Condition Hierarchy (Ancestors)

Neoplastic ProcessesNeoplasmsPathologic ProcessesPathological Conditions, Signs and SymptomsDisease AttributesPerceptual DisordersNeurobehavioral ManifestationsNeurologic ManifestationsNervous System DiseasesSigns and Symptoms

Intervention Hierarchy (Ancestors)

Data CollectionEpidemiologic MethodsInvestigative TechniquesHealth Care Evaluation MechanismsQuality of Health CareHealth Care Quality, Access, and EvaluationPublic HealthEnvironment and Public Health

Results Point of Contact

Title
Suresh K. Reddy, MD/Professor, Palliative Care Med
Organization
UT MD Anderson Cancer Center
sreddy@mdanderson.org
(713) 794-5362

Study Officials

  • Suresh Reddy, MD

    M.D. Anderson Cancer Center

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
Yes

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 31, 2015

First Posted

August 3, 2015

Study Start

February 2, 2016

Primary Completion

November 4, 2019

Study Completion

November 4, 2019

Last Updated

May 18, 2021

Results First Posted

May 18, 2021

Record last verified: 2021-04

Locations

US(1)