Dexamethasone for Cancer-Related Shortness of Breath

Recruiting at 2 trial locations

Overseen By David Hui

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: M.D. Anderson Cancer Center

Must not be taking: Megestrol, Corticosteroids

Disqualifiers: Delirium, Uncontrolled diabetes, Infection, others

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

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

Approved in 4 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 2

Duration: 4 weeks

135 Participants Needed

Trial Summary

What is the purpose of this trial?

This phase II trial studies how well dexamethasone works in controlling dyspnea in patients with cancer. Dexamethasone may help control dyspnea (shortness of breath) and improve lung function and quality of life in cancer patients.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications, but you cannot participate if you are using megestrol or chronic systemic corticosteroids. Also, if you are expected to start certain cancer treatments soon, you may not be eligible.

What data supports the effectiveness of the drug Dexamethasone for cancer-related shortness of breath?

Research shows that high-dose dexamethasone did not improve shortness of breath in cancer patients and increased serious adverse events (SAEs). ^{1 2 3 4 5}

Is dexamethasone safe for humans?

Dexamethasone is generally used to prevent nausea and vomiting during chemotherapy, but it can have side effects like increasing the risk of serious adverse events (SAEs) and potentially causing steroid-induced diabetes in some cancer patients. ^{1 3 5 6 7}

How is the drug dexamethasone different from other treatments for cancer-related shortness of breath?

Dexamethasone is a synthetic glucocorticoid (a type of steroid) that is unique because it is often used to manage side effects of cancer treatment, like nausea and inflammation, and it may also help with cancer-related shortness of breath by reducing inflammation. However, evidence supporting its effectiveness specifically for shortness of breath in cancer patients is limited. ^{1 2 3 8 9}

Research Team

David Hui

Principal Investigator

M.D. Anderson Cancer Center

Eligibility Criteria

This trial is for cancer patients experiencing significant shortness of breath, who are treated at MD Anderson Cancer Center or LBJ Hospital. They must not be on long-term steroids, have uncontrolled diabetes, infections needing antibiotics, recent major surgery, severe anxiety or certain other health issues.

Inclusion Criteria

I can care for myself but may need occasional help.

I have had significant shortness of breath, averaging 4 or more out of 10, over the last week.

I have been diagnosed with cancer.

Exclusion Criteria

You had an allergic reaction to dexamethasone before.

I have been diagnosed with delirium.

Your blood doesn't have enough oxygen even with extra oxygen from a machine.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2 weeks

Treatment

Participants receive dexamethasone or placebo orally twice daily for up to 28 days

4 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

2 weeks

2 visits (in-person)

Treatment Details

Interventions

• Dexamethasone

Trial Overview The study tests if dexamethasone can help control shortness of breath in cancer patients compared to a placebo. Participants will also fill out questionnaires about their symptoms and quality of life.

Participant Groups

Group I: Group I (dexamethasone) Experimental Treatment 2 Interventions

Patients receive dexamethasone PO BID on days 1-28 in the absence of disease progression or unacceptable toxicity.

Group II: Group II (placebo, dexamethasone) Active Control 3 Interventions

Patients receive placebo PO BID on days 1-14 and dexamethasone PO BID on days 15-28 in the absence of disease progression or unacceptable toxicity.

Dexamethasone is already approved in European Union, United States, Canada, Japan for the following indications:

Approved in European Union as Dexamethasone for:

• Inflammation
• Allergic reactions
• Respiratory diseases
• Skin conditions
• Eye diseases
• Immune system disorders

Approved in United States as Dexamethasone for:

• Inflammatory conditions
• Allergic states
• Respiratory diseases
• Blood disorders
• Neoplastic diseases
• Nervous system disorders

Approved in Canada as Dexamethasone for:

• Inflammation
• Allergic reactions
• Respiratory diseases
• Skin conditions
• Eye diseases

Approved in Japan as Dexamethasone for:

• Inflammatory conditions
• Allergic states
• Respiratory diseases
• Blood disorders

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

A double-blind, randomized controlled trial involving cancer patients demonstrated that dexamethasone significantly reduces dyspnoea, or difficulty breathing, indicating its efficacy in managing this distressing symptom.

The study's design and rigorous methodology provide strong evidence for the use of dexamethasone as a therapeutic option for alleviating dyspnoea in patients with cancer.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

In cancer with dyspnea, high-dose dexamethasone did not improve dyspnea and increased SAEs. Certo, M., Arnold, R.[2023]

In a study of 254 advanced non-squamous NSCLC patients, prophylactic dexamethasone did not significantly affect progression-free survival (PFS) or overall survival when used alongside PD-1 blockade therapy and chemotherapy.

The use of dexamethasone for preventing chemotherapy-associated adverse events (CAAEs) was found to be safe, as it did not lead to increased immune-related adverse effects (irAEs) or negatively impact clinical outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Impact of prophylactic dexamethasone on the efficacy of immune checkpoint inhibitors plus platinum-based chemotherapy in patients with advanced Non-Squamous Non-Small-Cell lung cancer. Yu, H., Chen, J., Zhou, Y., et al.[2023]

Dexamethasone (Dx) can reduce the effectiveness of cisplatin (cDDP) in inducing apoptosis in osteosarcoma cells, decreasing apoptosis by 10-25% when used as a pre or cotreatment.

The protective effect of Dx is linked to the upregulation of the survival factor Akt and a potential direct action on the mitochondrial apoptotic pathway, suggesting that the timing of glucocorticoid administration in cancer treatment should be carefully considered.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Dexamethasone protects against Cisplatin-induced activation of the mitochondrial apoptotic pathway in human osteosarcoma cells. Meyer, S., Eden, T., Kalirai, H.[2020]

References

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

In cancer with dyspnea, high-dose dexamethasone did not improve dyspnea and increased SAEs. [2023]

2. England pubmed.ncbi.nlm.nih.gov

Effect of dexamethasone on dyspnoea in patients with cancer (ABCD): a parallel-group, double-blind, randomised, controlled trial. [2023]

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

Dexamethasone for Dyspnea in Cancer Patients: A Pilot Double-Blind, Randomized, Controlled Trial. [2018]

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

The role of corticosteroids in the palliation of dyspnea in cancer patients: an evidence-based review. [2023]

5. Netherlands pubmed.ncbi.nlm.nih.gov

Impact of prophylactic dexamethasone on the efficacy of immune checkpoint inhibitors plus platinum-based chemotherapy in patients with advanced Non-Squamous Non-Small-Cell lung cancer. [2023]

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

Dexamethasone protects against Cisplatin-induced activation of the mitochondrial apoptotic pathway in human osteosarcoma cells. [2020]

7. Korea (South) pubmed.ncbi.nlm.nih.gov

A Pilot Study Evaluating Steroid-Induced Diabetes after Antiemetic Dexamethasone Therapy in Chemotherapy-Treated Cancer Patients. [2022]

8. China pubmed.ncbi.nlm.nih.gov

[Current applications of dexamethasone for cancer treatment]. [2018]

9. China pubmed.ncbi.nlm.nih.gov

[Effect of dexamethasone on expression of hypoxia inducible factor-1α and vascular endothelial growth factor in hypoxic mice]. [2010]