132 Participants Needed

Dexamethasone for Advanced Cancer

Recruiting at 1 trial location
Age: 18+
Sex: Any
Trial Phase: Phase 2
Sponsor: M.D. Anderson Cancer Center
Prior Safety DataThis treatment has passed at least one previous human trial
Approved in 4 JurisdictionsThis treatment is already approved in other countries

What You Need to Know Before You Apply

What is the purpose of this trial?

The goal of this clinical research study is to learn if dexamethasone can help to control symptoms such as fatigue, pain, nausea, weight loss, loss of appetite, sleep problems, and/or depression in patients with advanced cancer.

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 dexamethasone generally safe for humans?

Dexamethasone is used in various treatments, but it can cause side effects like neuro-psychiatric issues (mental health problems) and myopathy (muscle weakness), especially in children with leukemia. It is generally well-tolerated in combination with other drugs for multiple myeloma, but its safety can vary depending on the condition and patient.12345

How is the drug Dexamethasone unique in treating advanced cancer?

Dexamethasone is unique in treating advanced cancer because it is a corticosteroid that not only helps manage cancer pain and side effects like nausea but also has the potential to enhance the effectiveness of other cancer treatments, such as docetaxel, by reducing inflammation and inhibiting tumor growth.678910

What data supports the effectiveness of the drug Dexamethasone for advanced cancer?

Dexamethasone is commonly used in advanced cancer patients to help with symptoms like appetite loss, nausea, and fatigue, with positive effects seen within the first week and lasting beyond four weeks. It is also used in combination with other treatments, like docetaxel, to enhance their effectiveness in certain cancers, such as prostate cancer.2691011

Who Is on the Research Team?

SY

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.
See 3 more

Exclusion Criteria

Inability to complete the baseline assessment forms
Patients with a history of diabetes will be excluded
I do not have sepsis or any current infections.
See 7 more

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?
2Treatment groups
Active Control
Placebo Group
Group I: DexamethasoneActive Control1 Intervention
Group II: PlaceboPlacebo Group2 Interventions

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

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Approved in European Union as Dexamethasone for:
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Approved in United States as Dexamethasone for:
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Approved in Canada as Dexamethasone for:
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Approved in Japan as Dexamethasone for:

Find a Clinic Near You

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

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.
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]
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.
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]
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.
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]

Citations

Dexamethasone prescribing for cancer pain between palliative care and radiation oncology. [2022]
The use of corticosteroids in Swedish palliative care. [2009]
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]
Dexamethasone potentiates the antiangiogenic activity of docetaxel in castration-resistant prostate cancer. [2021]
Benefit of dexamethasone compared with prednisolone for childhood acute lymphoblastic leukaemia: results of the UK Medical Research Council ALL97 randomized trial. [2022]
Dexamethasone versus prednisone for induction therapy in childhood acute lymphoblastic leukemia: a systematic review and meta-analysis. [2018]
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. [2021]
Adverse drug reactions of oral dexamethasone in children and adolescents with childhood acute lymphoblastic leukemia: a systematic review. [2022]
A Noninterventional, Observational, European Post-Authorization Safety Study of Patients With Relapsed/Refractory Multiple Myeloma Treated With Lenalidomide. [2021]
10.United Statespubmed.ncbi.nlm.nih.gov
Dexamethasone protects against Cisplatin-induced activation of the mitochondrial apoptotic pathway in human osteosarcoma cells. [2020]
Dexamethasone inhibits the proliferation of tumor cells. [2022]
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