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Corticosteroid

Dexamethasone for Advanced Cancer

Phase 2

Waitlist Available

Led By Sriram Yennurajalingam, MD

Research Sponsored by M.D. Anderson Cancer Center

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Must be 18 years of older

Present with 3 or more symptoms during the last 24 hours (Pain, fatigue, chronic nausea, and anorexia/cachexia, sleep problems, depression or poor appetite), with an average intensity of >/= 4 on a 0-10 scale

Must not have

Sepsis and/or acute, chronic, or ongoing infections

Known history of human immunodeficiency virus (HIV)

Timeline

Screening 3 weeks

Treatment Varies

Follow Up baseline to day 15

Summary

This trial is testing if dexamethasone can help manage symptoms of advanced cancer, such as fatigue, pain, nausea, etc.

Who is the study for?

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.

What is being tested?

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.

What are the potential side effects?

Dexamethasone may cause side effects including increased blood sugar levels (especially important for diabetics), insomnia, indigestion, increased appetite and weight gain. It might also lead to mood swings or muscle weakness.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am 18 years old or older.

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I've had 3 or more symptoms like pain or fatigue, with an intensity of 4 or more.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I do not have sepsis or any current infections.

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I have been diagnosed with HIV.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ baseline to day 15

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~baseline to day 15

This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline to day 15 for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Functional Assessment of Chronic Illness Therapy - Fatigue (FACIT-F) Subscale Scores

Secondary study objectives

Desire for food

Edmonton Symptom Assessment System (ESAS) Nausea

Edmonton Symptom Assessment System (ESAS) Pain

+2 more

Trial Design

2Treatment groups

Active Control

Placebo Group

Group I: DexamethasoneActive Control1 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: PlaceboPlacebo Group2 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.

0 / 4Eligibility criteria met