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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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline to day 15
Awards & highlights

Study 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.Check my eligibility
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.See study design
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.

Timeline

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Functional Assessment of Chronic Illness Therapy - Fatigue (FACIT-F) Subscale Scores
Secondary outcome measures
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.

Find a Location

Who is running the clinical trial?

M.D. Anderson Cancer CenterLead Sponsor
2,974 Previous Clinical Trials
1,789,337 Total Patients Enrolled
American Cancer Society, Inc.OTHER
224 Previous Clinical Trials
110,323 Total Patients Enrolled
Sriram Yennurajalingam, MDPrincipal InvestigatorM.D. Anderson Cancer Center
6 Previous Clinical Trials
491 Total Patients Enrolled

Media Library

Dexamethasone (Corticosteroid) Clinical Trial Eligibility Overview. Trial Name: NCT00489307 — Phase 2
Solid Tumors Research Study Groups: Dexamethasone, Placebo
Solid Tumors Clinical Trial 2023: Dexamethasone Highlights & Side Effects. Trial Name: NCT00489307 — Phase 2
Dexamethasone (Corticosteroid) 2023 Treatment Timeline for Medical Study. Trial Name: NCT00489307 — Phase 2

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

How does Dexamethasone compare in terms of safety to other treatments?

"Although there is limited clinical data supporting Dexamethasone's efficacy, its safety has been studied and our team at Power assigned it a score of 2."

Answered by AI

What are the principal aims of this experiment?

"This trial's primary objective is to evaluate the impact of an intervention on Cancer-Related Fatigue (CRF) over a 15 day period, as measured by change in scores from Functional Assessment of Chronic Illness-Fatigue (FACITF)'s fatigue subscale. Secondary outcomes encompass changes in Edmonton Symptom Assessment System (ESAS) Nausea and Pain, along with Hospital Anxiety and Depression Scale (HADS) Depression scores determined at baseline and Day 15 respectively."

Answered by AI

Could you please provide a review of the research done on Dexamethasone?

"Presently, 552 medical trials are in process researching Dexamethasone. Of those studies which remain active, 143 have reached phase 3. Elk Grove Village is the primary focus of these investigations; however, 18652 locations globally are running clinical tests for this drug."

Answered by AI

In what cases is Dexamethasone usually recommended?

"Dexamethasone is frequently prescribed to treat ophthalmia and sympathetic, in addition to other conditions such as eye, branch retinal vein occlusion, and macular edema."

Answered by AI

Is this research still open for recruitment?

"Clinicaltrials.gov reports that this medical trial has stopped recruiting participants; the initial posting took place on February 1st 2006 and was last updated on December 5th 2022. Despite this, 1003 other trials are currently welcoming volunteers into their studies."

Answered by AI

How many subjects are being evaluated in this research project?

"At this current juncture, this particular clinical trial is not recruiting any new participants. The initial post date was February 1st 2006 and the most recent data update occurred December 5th 2022. If you are looking into similar studies, 451 medical trials concerning tumors, solid are actively seeking volunteers while there are currently 552 Dexamethasone-based experiments in need of patient recruitment."

Answered by AI
Recent research and studies
clinicaltrials.govStudy
Dexamethasone for Symptom Burden in Advanced Cancer Patients
2006. "Dexamethasone for Symptom Burden in Advanced Cancer Patients". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT00489307.
~7 spots leftby Apr 2025
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