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Opioid
Fentanyl + Morphine for Shortness of Breath in Cancer
Phase 3
Recruiting
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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up days 1-4, 6-7, 9-11, 13-14, and 16-18
Awards & highlights
Study 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.Check my eligibility
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.See study design
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 belowSelect...
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.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ days 1-4, 6-7, 9-11, 13-14, and 16-18
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~days 1-4, 6-7, 9-11, 13-14, and 16-18
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Change in modified Borg scale dyspnea intensity before and after the Shuttle Walk Test (SWT)
Secondary outcome measures
Addictive potential
Daily dyspnea intensity and unpleasantness
Dyspnea severity and functional impairment
+10 moreTrial 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
13,660 Previous Clinical Trials
40,924,218 Total Patients Enrolled
1 Trials studying Blood Cancers
70 Patients Enrolled for Blood Cancers
M.D. Anderson Cancer CenterLead Sponsor
2,972 Previous Clinical Trials
1,787,167 Total Patients Enrolled
David HuiPrincipal InvestigatorM.D. Anderson Cancer Center
9 Previous Clinical Trials
1,791 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I need more than 6 liters of oxygen per minute.You have a history of drug abuse or have shown signs of potential opioid misuse.I am 18 years old or older.I have been diagnosed with high blood pressure in the lungs.My cancer is currently active.I can complete all required study check-ups and tests.Your heart beats more than 120 times per minute when you are resting.I feel very short of breath even when I am resting.I have been on strong painkillers at a stable dose for the last week.I can speak English or Spanish.I have not had a heart attack or unstable chest pain in the last month.Your blood pressure is very high when you join the study.You have had an allergic reaction to fentanyl or morphine sulfate in the past.I am currently taking benzodiazepines.Your red blood cell count is very low and has not been fixed in the past month.Your bilirubin levels are more than five times the normal limit and have not been lowered before joining the study.I have been diagnosed with severe confusion or delirium.I was diagnosed with a lung clot less than 2 weeks ago.I am being treated as an outpatient at one of the centers involved in the study.I can care for myself but cannot do normal activities or work.I can walk by myself or with help from a device.I have been diagnosed with fluid in my chest due to cancer and will undergo a procedure to remove it soon.I feel short of breath with moderate effort, rating it 4 or more out of 10.
Research Study Groups:
This trial has the following groups:- Group 1: Group I (shuttle walk test, FBT)
- Group 2: Group III (shuttle walk test, placebo)
- Group 3: Group II (shuttle walk test, morphine)
Awards:
This trial has 1 awards, including:- Pivotal Trial - The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Are there similar ongoing investigations to this one involving other drugs in the same class as Morphine?
"There are a total of 104 ongoing clinical studies evaluating the effects of morphine. Out of these, 26 are large-scale Phase 3 trials. Although several of the trials for Morphine are based in Boston, there are actually 200 different locations running clinical trials for Morphine."
Answered by AI
What does the FDA's stance on Morphine currently entail?
"Morphine has undergone Phase 3 clinical trials, meaning that there is both supporting efficacy data and multiple rounds of data affirming its safety. Consequently, our team has given it a score of 3."
Answered by AI
Why is Morphine regularly prescribed to patients?
"Morphine can be used as anesthesia for various medical procedures including but not limited to general anesthesia, conduction, and therapeutic procedures."
Answered by AI
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