Fentanyl + Morphine for Shortness of Breath in Cancer

Overseen By David Hui

Age: 18+

Sex: Any

Trial Phase: Phase 3

Sponsor: M.D. Anderson Cancer Center

Must be taking: Strong opioids

Must not be taking: Benzodiazepines

Disqualifiers: Substance use disorder, Delirium, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Pivotal Trial (Near Approval) This treatment is in the last trial phase before FDA approval

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: 6

Duration: 19 days

150 Participants Needed

Trial Summary

What is the purpose of this trial?

This phase II trial studies fentanyl buccal tablet or morphine to see how well it works compared to a placebo in controlling shortness of breath during or after physical activity in cancer patients. Fentanyl sublingual tablet and morphine are opioids normally used to control pain that may also help to prevent or control shortness of breath during or after physical activity in cancer patients.

Do I need to stop my current medications to join the trial?

The trial does not specify if you need to stop all current medications, but you must not be using scheduled benzodiazepines unless you can stop during the study. You also need to be on a stable dose of strong opioids like morphine.

What data supports the effectiveness of the drug Fentanyl Citrate Buccal Tablet combined with Morphine for shortness of breath in cancer patients?

Research shows that fentanyl, when used in forms like buccal tablets, can effectively manage breakthrough cancer pain, similar to morphine, and may offer additional benefits like convenience and fewer side effects. This suggests that the combination of fentanyl and morphine could be effective for managing symptoms like shortness of breath in cancer patients. ^{1 2 3 4 5}

Is the combination of Fentanyl and Morphine safe for treating shortness of breath in cancer patients?

Morphine, used in controlled-release form (MS Contin), has been shown to be effective for cancer pain relief, but it can cause side effects like drowsiness, nausea, vomiting, constipation, and confusion. In some cases, it can lead to serious issues like respiratory depression (trouble breathing). These side effects are generally manageable, but they highlight the importance of careful monitoring and dose adjustment. ^{3 4 6 7 8}

How is the drug Fentanyl + Morphine unique for treating shortness of breath in cancer patients?

The combination of Fentanyl Citrate Buccal Tablet and Morphine is unique because it uses two potent opioids, which are typically used for breakthrough cancer pain, to address shortness of breath in cancer patients. This approach leverages the known efficacy of these opioids for pain relief, potentially offering a novel way to manage breathlessness, a symptom with limited standard treatments. ^{5 9 10 11 12}

Research Team

David Hui

Principal Investigator

M.D. Anderson Cancer Center

Eligibility Criteria

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.

Inclusion Criteria

I am 18 years old or older.

My cancer is currently active.

I can complete all required study check-ups and tests.

Exclusion 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 have been diagnosed with high blood pressure in the lungs.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive either fentanyl buccal tablet, morphine, or placebo and complete shuttle walk tests on specified days

19 days

6 visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Treatment Details

Interventions

• Fentanyl Citrate Buccal Tablet
• Morphine

Trial Overview 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.

Participant Groups

Group I: Group II (shuttle walk test, morphine) Experimental Treatment 4 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 Treatment 4 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 Control 4 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.

Who Is Running the Clinical Trial?

M.D. Anderson Cancer Center

Lead Sponsor

Trials

3,107

Recruited

1,813,000+

National Cancer Institute (NCI)

Collaborator

Trials

14,080

Recruited

41,180,000+

Findings from Research

In a study of 504 advanced cancer patients, those using transdermal fentanyl reported higher overall satisfaction with their pain management compared to those using sustained-release oral morphine.

Patients on transdermal fentanyl experienced significantly fewer and less impactful side effects from their pain medication, which may contribute to their greater satisfaction, despite being older and having lower functioning and well-being scores.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Quality of life and cancer pain: satisfaction and side effects with transdermal fentanyl versus oral morphine. Payne, R., Mathias, SD., Pasta, DJ., et al.[2022]

A patient with severe neuralgia experienced respiratory depression after taking a single 20 mg dose of controlled release morphine sulfate (MS Contin), highlighting a potential safety concern with this medication.

The immediate reversal of respiratory depression was achieved with nalorphine chloride, demonstrating the effectiveness of this intervention in managing opioid-related side effects.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Respiratory depression following controlled-release morphine sulfate tablets]. Hoogslag, PA., van Dijk, B., Vinks, AA.[2013]

In a study involving 66 patients, adherence to established guidelines for titrating MS Contin (controlled-release morphine) resulted in effective pain management, with about 75% of patients reporting no or slight pain by the end of the study.

Only 5% of patients discontinued due to drug-related side effects, indicating that MS Contin is generally well-tolerated; however, there is a need for better management of side effects and consideration of patient-controlled titration to optimize pain relief.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Evaluation of dosing guidelines for the use of oral controlled-release morphine (MS Contin tablets). Warfield, CA.[2019]

References

1. Thailand pubmed.ncbi.nlm.nih.gov

Management of cancer-related pain with transdermal fentanyl. [2013]

2. United States pubmed.ncbi.nlm.nih.gov

Quality of life and cancer pain: satisfaction and side effects with transdermal fentanyl versus oral morphine. [2022]

3. Netherlands pubmed.ncbi.nlm.nih.gov

[Respiratory depression following controlled-release morphine sulfate tablets]. [2013]

4. England pubmed.ncbi.nlm.nih.gov

Experience with a controlled-release oral morphine for cancer pain management. [2013]

5. England pubmed.ncbi.nlm.nih.gov

Efficacy of intranasal fentanyl spray versus other opioids for breakthrough pain in cancer. [2018]

6. United States pubmed.ncbi.nlm.nih.gov

Evaluation of dosing guidelines for the use of oral controlled-release morphine (MS Contin tablets). [2019]

7. United States pubmed.ncbi.nlm.nih.gov

Recovery of morphine from a controlled-release preparation. A source of opioid abuse. [2019]

8. England pubmed.ncbi.nlm.nih.gov

A clinical survey of controlled-release morphine sulphate for cancer pain relief in a Japanese hospice. [2013]

9. Germany pubmed.ncbi.nlm.nih.gov

Fentanyl treatment for end-of-life dyspnoea relief in advanced cancer patients. [2019]

10. United States pubmed.ncbi.nlm.nih.gov

Fentanyl for the relief of refractory breathlessness: a systematic review. [2018]

11. England pubmed.ncbi.nlm.nih.gov

Utilization of fentanyl buccal tablets in England: exploring off-label use reported in a cohort study. [2015]

12. United States pubmed.ncbi.nlm.nih.gov

Subcutaneous fentanyl and sufentanil infusion substitution for morphine intolerance in cancer pain management. [2021]