Dexamethasone for Advanced Cancer

Not currently recruiting at 1 trial location

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: M.D. Anderson Cancer Center

Must not be taking: Megestrol, Oral corticosteroids

Disqualifiers: Diabetes, HIV, Anemia, Neutropenia, others

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: 5

Duration: 4 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests whether dexamethasone, a corticosteroid medication, can manage symptoms such as fatigue, pain, nausea, appetite loss, sleep issues, and depression in people with advanced cancer. Participants will receive either dexamethasone or a placebo for two weeks, followed by dexamethasone for all. This study may suit those with advanced cancer experiencing at least three of these symptoms at moderate to severe levels. As a Phase 2 trial, the research focuses on measuring the treatment's effectiveness in an initial, smaller group.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop all current medications, but you cannot participate if you are currently taking Megestrol and haven't stopped it for more than 7 days. Also, you cannot be on oral corticosteroids for more than 7 days before joining the study.

Is there any evidence suggesting that dexamethasone is likely to be safe for humans?

Research has shown that dexamethasone is often used in cancer treatment and is usually well-tolerated. However, some safety points require consideration. One study found that taking more than 8 mg of dexamethasone per day or using it for over two weeks might lead to serious side effects, such as unexpected medical problems. In this trial, the dose and duration are lower, potentially reducing risks.

Another study found that dexamethasone can significantly affect the immune system when used with chemotherapy, possibly impacting the body's ability to fight infections. Despite these concerns, dexamethasone remains a common part of cancer care, especially for managing symptoms like nausea and pain. Participants should always consult the trial team and their doctor to understand the risks and benefits for their specific situation. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising for advanced cancer?

Most treatments for advanced cancer focus on targeting cancer cells directly, but dexamethasone works differently by reducing inflammation and managing symptoms. This corticosteroid is particularly effective at alleviating side effects like nausea and swelling, which can significantly improve the quality of life for patients. Researchers are excited about dexamethasone because it can quickly ease symptoms, offering relief within days, which is crucial for advanced cancer patients who need immediate support. Plus, its use in this trial includes a structured tapering schedule that may help balance effectiveness with minimizing potential side effects.

What evidence suggests that dexamethasone might be an effective treatment for symptoms in advanced cancer?

Studies have shown that dexamethasone can alleviate symptoms such as tiredness, loss of appetite, and depression in patients with advanced cancer. It is often used because it improves these specific symptoms. For instance, dexamethasone has been found to manage cancer-related tiredness and pain effectively. In some cases, it has also helped with depression and weight loss. In this trial, participants will receive either dexamethasone or a placebo for 14 days. While dexamethasone can be effective, using it for more than two weeks or at high doses might lead to serious side effects. Overall, research suggests that dexamethasone can ease several distressing symptoms of advanced cancer. ^{1 3 6 7 8}

Who Is on the Research Team?

Sriram Yennurajalingam, MD

Principal Investigator

M.D. Anderson Cancer Center

Are You a Good Fit for This Trial?

This trial is for adults with advanced cancer experiencing at least three symptoms like pain, fatigue, or nausea. They must have a life expectancy of 30 days or more and not be candidates for aggressive cancer therapy. People with allergies to Dexamethasone, anemia, HIV, diabetes, recent major surgery, ongoing infections or those on certain medications are excluded.

Inclusion Criteria

No clinical evidence of cognitive failure as evidenced by Memorial Delirium Assessment Scale (MDAS) score of 13 or less at baseline

Life expectancy =/> 30 days

I am using topical or inhaled steroids, or have used oral steroids for 7 days or less.

Exclusion Criteria

I do not have sepsis or any current infections.

Inability to complete the baseline assessment forms

Patients with a history of diabetes will be excluded

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive either dexamethasone or placebo for 14 days, followed by dexamethasone for another 14 days with dose tapering

4 weeks

4 visits (in-person or phone)

Follow-up

Participants are monitored for safety and toxicity after treatment

2 weeks

1 visit (in-person or phone)

What Are the Treatments Tested in This Trial?

Interventions

• Dexamethasone
• Placebo

Trial Overview

The study is testing whether Dexamethasone can alleviate symptoms such as fatigue, pain and nausea in patients with advanced solid tumors. Participants will either receive Dexamethasone or a placebo to compare the effectiveness in symptom control.

How Is the Trial Designed?

Group I: Dexamethasone Active Control 1 Intervention

Dexamethasone 4 mg orally two times a day for 14 days. On day 15 \[ ± 3 days\], all patients receive dexamethasone 4 mg orally twice a day for 7 days, and then the dose of dexamethasone tapered to 2 mg orally twice a day between days 22 to 28.

Group II: Placebo Placebo Group 2 Interventions

Placebo by mouth (PO) twice daily for 14 days. On day 15 \[ ± 3 days\], all patients receive dexamethasone 4 mg orally twice a day for 7 days, and then the dose of dexamethasone tapered to 2 mg orally twice a day between days 22 to 28.

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+

American Cancer Society, Inc.

Collaborator

Trials

237

Recruited

110,000+

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]

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 (DEX) is more effective than prednisone (PRED) in reducing the risk of serious events in children with acute lymphoblastic leukemia (ALL), including central nervous system relapse, based on a meta-analysis of eight studies.

However, DEX is associated with a higher risk of severe side effects, such as increased mortality during induction therapy and neuro-psychiatric issues, raising concerns about its overall safety despite its efficacy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Dexamethasone versus prednisone for induction therapy in childhood acute lymphoblastic leukemia: a systematic review and meta-analysis. Teuffel, O., Kuster, SP., Hunger, SP., et al.[2018]

Dexamethasone, while effective for treating pediatric acute lymphoblastic leukemia (ALL), can cause significant neurobehavioral side effects that negatively impact health-related quality of life (HRQoL) in patients, as identified through the Strengths and Difficulties Questionnaire (SDQ).

The current study aims to replicate previous findings that adding physiological hydrocortisone during dexamethasone treatment may alleviate these neurobehavioral issues, with a randomized controlled trial design to assess changes in SDQ scores and other quality of life measures in affected patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Study protocol: DexaDays-2, hydrocortisone for treatment of dexamethasone-induced neurobehavioral side effects in pediatric leukemia patients: a double-blind placebo controlled randomized intervention study with cross-over design. van Hulst, AM., Verwaaijen, EJ., Fiocco, MF., et al.[2021]

In a large observational study of 2150 patients with relapsed/refractory multiple myeloma, lenalidomide plus dexamethasone demonstrated a favorable safety profile, with lower incidence rates of neuropathy and infections compared to other treatments like bortezomib and thalidomide.

The study confirmed that lenalidomide's safety profile in a real-world setting is consistent with previous clinical trial data, with no new safety concerns identified, although it did show a higher incidence of neutropenia compared to bortezomib and thalidomide.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A Noninterventional, Observational, European Post-Authorization Safety Study of Patients With Relapsed/Refractory Multiple Myeloma Treated With Lenalidomide. Gamberi, B., Berthou, C., Hernandez, M., et al.[2021]

Adolescents with Acute Lymphoblastic Leukaemia (ALL) experience more severe adverse drug reactions (ADRs) from oral dexamethasone compared to younger children, with higher incidences of issues like hyperglycemia, infections, and thrombosis, based on a review of 11 studies.

The increased severity of ADRs in adolescents may be linked to age-related differences in how dexamethasone is processed in the body and the effects of puberty, highlighting the need for healthcare professionals to closely monitor this age group during treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Adverse drug reactions of oral dexamethasone in children and adolescents with childhood acute lymphoblastic leukemia: a systematic review. Hu, L., Kim Emily, AN., Juh Allen, YE.[2022]

In a study involving 1603 children with newly diagnosed acute lymphoblastic leukaemia (ALL), substituting dexamethasone for prednisolone significantly reduced the risk of isolated central nervous system (CNS) relapse by half.

Dexamethasone treatment improved event-free survival rates to 84.2% compared to 75.6% with prednisolone over 5 years, indicating that despite its increased toxicity, dexamethasone should be considered a standard part of therapy for childhood ALL.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Benefit of dexamethasone compared with prednisolone for childhood acute lymphoblastic leukaemia: results of the UK Medical Research Council ALL97 randomized trial. Mitchell, CD., Richards, SM., Kinsey, SE., et al.[2022]

Citations

1.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC10979672/

Use of Dexamethasone for Severe Fatigue in the ...

Other studies have shown that dexamethasone improves specific symptom clusters such as the fatigue, anorexia–cachexia, and depression cluster.

2.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC4839331/

Dexamethasone co-medication in cancer patients undergoing ...

Dex is routinely prescribed to patients with advanced cancer in a wide range of doses (0.5 mg up to 16 mg daily) for a variety of additional reasons: fatigue, ...

3.

mdpi.com

mdpi.com/2072-6694/17/10/1630

Effectiveness of Systemic Corticosteroids in Managing ...

A previous study reported that 54.6% of patients with advanced cancer experienced cancer pain, with 40.7% rating its intensity as ≥5 on a 0–10 numerical rating ...

4.

sciencedirect.com

sciencedirect.com/science/article/abs/pii/S0885392423007108

Impact of Dosing and Duration of Dexamethasone on ...

Conclusion. Dexamethasone use may contribute to serious AEs in cancer patients, especially at doses >8 mg/day and when used for more than two weeks.

5.

ascopubs.org

ascopubs.org/doi/10.1200/JCO.2019.37.31_suppl.110

High/low dose dexamethasone with physical activity for ...

Physical activity (PA) improves CRF with lower adherence in advanced cancer. Dexamethasone (Dex) improves CRF but has long-term side effects.

6.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC12109982/

Effectiveness of Systemic Corticosteroids in Managing Cancer ...

A previous study reported that 54.6% of patients with advanced cancer experienced cancer pain, with 40.7% rating its intensity as ≥5 on a 0–10 ...

7.

jpsmjournal.com

jpsmjournal.com/article/S0885-3924(23)00710-8/fulltext

Impact of Dosing and Duration of Dexamethasone on ...

The primary outcome was Grade 3+ AEs (CTCAE v4.03). We evaluated the association between AEs and dexamethasone exposure using multivariable ...

8.

asahq.org

asahq.org/about-asa/newsroom/news-releases/2021/10/anti-nausea-drug-may-help-some-cancer-patients-survive-longer

Anti-nausea drug may help some cancer patients survive ...

Researchers found dexamethasone can improve mid- to long-term outcomes in patients with non-immunogenic cancers (those that don't provoke a ...