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Opioid

Fentanyl + Morphine for Shortness of Breath in Cancer

Phase 3
Waitlist Available
Led By David Hui
Research Sponsored by M.D. Anderson Cancer Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Age >= 18 years (yrs)
Diagnosis of cancer with evidence of active disease
Must not have
Supplemental oxygen requirement > 6 L/min
Diagnosis of pulmonary hypertension
Timeline
Screening 3 weeks
Treatment Varies
Follow Up days 1-4, 6-7, 9-11, 13-14, and 16-18
Awards & highlights
Pivotal Trial

Summary

This trial looks at how well fentanyl and morphine work to control shortness of breath during or after physical activity, compared to a placebo.

Who is the study for?
This trial is for adults over 18 with active cancer, able to walk and complete assessments. They must live near the centers, speak English or Spanish, be on strong opioids with a stable dose, and experience significant shortness of breath during exertion but not at rest. Exclusions include severe heart issues, high oxygen needs, substance abuse history, certain allergies or conditions.
What is being tested?
The study compares fentanyl buccal tablets and morphine against a placebo in controlling exertional dyspnea (shortness of breath) in cancer patients. It's a phase II trial that includes quality-of-life assessments to determine how these treatments affect physical activity-related breathing difficulties.
What are the potential side effects?
Potential side effects from fentanyl or morphine may include nausea, constipation, drowsiness, confusion, addiction potential and respiratory depression which can lead to difficulty breathing especially if dosages are not properly managed.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am 18 years old or older.
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My cancer is currently active.
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I can complete all required study check-ups and tests.
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I have been on strong painkillers at a stable dose for the last week.
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I can care for myself but cannot do normal activities or work.
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I can walk by myself or with help from a device.
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I feel short of breath with moderate effort, rating it 4 or more out of 10.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I need more than 6 liters of oxygen per minute.
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I have been diagnosed with high blood pressure in the lungs.
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I feel very short of breath even when I am resting.
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I am currently taking benzodiazepines.
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I have been diagnosed with severe confusion or delirium.
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I was diagnosed with a lung clot less than 2 weeks ago.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~days 1-4, 6-7, 9-11, 13-14, and 16-18
This trial's timeline: 3 weeks for screening, Varies for treatment, and days 1-4, 6-7, 9-11, 13-14, and 16-18 for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Change in modified Borg scale dyspnea intensity before and after the Shuttle Walk Test (SWT)
Secondary study objectives
Addictive potential
Daily dyspnea intensity and unpleasantness
Dyspnea severity and functional impairment
+10 more

Awards & Highlights

Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

Trial Design

3Treatment groups
Experimental Treatment
Active Control
Group I: Group II (shuttle walk test, morphine)Experimental Treatment4 Interventions
Patients complete shuttle walk test on days 1, 5, 8, 12, 15, and 19. Patients also receive morphine PO daily on days 6-19.
Group II: Group I (shuttle walk test, FBT)Experimental Treatment4 Interventions
Patients complete shuttle walk test on days 1, 5, 8, 12, 15, and 19. Patients also receive FBT sublingually daily on days 6-19.
Group III: Group III (shuttle walk test, placebo)Active Control4 Interventions
Patients complete shuttle walk test on days 1, 5, 8, 12, 15, and 19. Patients also receive placebo (sublingually or PO) daily on days 6-19.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Morphine
2013
Completed Phase 4
~2230

Find a Location

Who is running the clinical trial?

National Cancer Institute (NCI)NIH
13,925 Previous Clinical Trials
41,017,851 Total Patients Enrolled
2 Trials studying Blood Cancers
112 Patients Enrolled for Blood Cancers
M.D. Anderson Cancer CenterLead Sponsor
3,066 Previous Clinical Trials
1,802,095 Total Patients Enrolled
David HuiPrincipal InvestigatorM.D. Anderson Cancer Center
9 Previous Clinical Trials
1,791 Total Patients Enrolled

Media Library

Fentanyl Citrate Buccal Tablet (Opioid) Clinical Trial Eligibility Overview. Trial Name: NCT04188418 — Phase 3
Blood Cancers Research Study Groups: Group I (shuttle walk test, FBT), Group III (shuttle walk test, placebo), Group II (shuttle walk test, morphine)
Blood Cancers Clinical Trial 2023: Fentanyl Citrate Buccal Tablet Highlights & Side Effects. Trial Name: NCT04188418 — Phase 3
Fentanyl Citrate Buccal Tablet (Opioid) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04188418 — Phase 3
~23 spots leftby Aug 2025
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