Dexamethasone for Cancer-Related Shortness of Breath

Not currently 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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores how well dexamethasone, a medication, manages shortness of breath in cancer patients. Researchers aim to determine if it improves lung function and enhances quality of life. Participants may be divided into groups, with some taking dexamethasone throughout and others starting with a placebo before switching to dexamethasone. The trial seeks cancer patients who experience significant shortness of breath and show signs of lung involvement, such as lung cancer or airway issues. As a Phase 2 trial, the research focuses on measuring the treatment's effectiveness in an initial, smaller group of people.

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.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research shows that patients usually tolerate dexamethasone well. In past studies, it improved breathing difficulties in cancer patients. Most participants did not experience serious side effects. However, higher doses sometimes caused more side effects than a placebo. Common side effects include chest pain, irregular heartbeat, and swelling. Despite these risks, dexamethasone is already used for many conditions, indicating its well-established safety. Always consult a healthcare provider about possible side effects. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising?

Researchers are excited about using dexamethasone for cancer-related shortness of breath because it offers a potential new way to manage this challenging symptom. Unlike traditional treatments that might focus on bronchodilators or opioids, dexamethasone is a corticosteroid that can reduce inflammation and potentially improve breathing more directly. This approach could not only provide quicker relief but also minimize the need for stronger medications with more side effects. Additionally, the study explores different dosing schedules, which might offer more flexibility and effectiveness in treatment.

What evidence suggests that dexamethasone might be an effective treatment for cancer-related shortness of breath?

This trial will compare the effects of dexamethasone with a placebo on cancer-related shortness of breath. Research has shown that high doses of dexamethasone did not significantly help cancer patients with shortness of breath compared to a placebo. Although dexamethasone treats many conditions, it did not noticeably ease breathing problems for these patients. Additionally, those taking dexamethasone experienced more side effects than those taking a placebo. These findings suggest that dexamethasone may not effectively manage breathing difficulties in cancer patients. ^{2 3 6 7 8}

Who Is on the Research Team?

David Hui

Principal Investigator

M.D. Anderson Cancer Center

Are You a Good Fit for This Trial?

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.

Seen at an outpatient clinic at MD Anderson Cancer Center or Lyndon B. Johnson (LBJ) Hospital General Oncology Clinic

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 for a Trial Participant

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)

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Published Research Related to This Trial

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]

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]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10618956/

Effect of Dexamethasone for Dyspnea in Patients with Cancer High dose dexamethasone did not improve dyspnea in patients with cancer more than placebo and was associated with more adverse events. Funding: National Cancer ...

2. sciencedirect.com sciencedirect.com/science/article/abs/pii/S1470204522005083

Articles Effect of dexamethasone on dyspnoea in patients ... High-dose dexamethasone did not improve dyspnoea in patients with cancer more effectively than placebo and was associated with a higher frequency of adverse ...

3. clinicaltrials.gov clinicaltrials.gov/study/NCT01670097

NCT01670097 | Dexamethasone Dyspnea Study The goal of this clinical research study is to learn if dexamethasone can help reduce shortness of breath in cancer patients.

4. jpsmjournal.com jpsmjournal.com/article/S0885-3924(24)00852-2/abstract

Predictive Biomarkers of Dyspnea Response to ... In the Alleviating Breathlessness in Cancer Patients with Dexamethasone (ABCD) trial, dexamethasone did not improve dyspnea more than placebo in unselected ...

5. ascopubs.org ascopubs.org/doi/10.1200/JCO.2022.40.16_suppl.12112

A parallel-group, double-blind, randomized clinical trial ... Conclusions: High dose dexamethasone did not improve dyspnea in patients with cancer more than placebo and was associated with more adverse ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC4958556/

Dexamethasone for Dyspnea in Cancer Patients Our preliminary data suggest that dexamethasone may be associated with rapid improvement in dyspnea and was well tolerated. Further studies are ...

7. mayoclinic.org mayoclinic.org/drugs-supplements/dexamethasone-oral-route/description/drg-20075207

Dexamethasone (oral route) - Side effects & dosage Dexamethasone is a corticosteroid (cortisone-like medicine or steroid). It works on the immune system to help relieve swelling, redness, itching, and allergic ...

8. webmd.com webmd.com/drugs/2/drug-6751/dexamethasone-sodium-phosphate-injection/details

Dexamethasone (Decadron) - Uses, Side Effects, and More What are the serious side effects of dexamethasone? · Chest pain · Irregular heartbeat · Shortness of breath · Stretched or shiny skin · Swollen body ...