NCT00489307

Dexamethasone for Symptom Burden in Advanced Cancer Patients

Active, enrolled Phase 2 Results posted Last updated 12 November 2025

What this trial tests

Phase 2 trial testing Dexamethasone in Solid Tumors in 132 participants. Participants enrolled and being followed up; not accepting new ones.

Timeline

2 February 2006

Primary endpoint
28 February 2021

28 February 2028

Quick facts

Lead sponsor	M.D. Anderson Cancer Center
Phase	Phase 2
Status	Active, enrolled
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	triple
Primary purpose	treatment
Enrollment	132
Start date	2 February 2006
Primary completion	28 February 2021
Estimated completion	28 February 2028
Sites	2 locations across United States

Drugs / interventions tested

• Dexamethasone (dexamethasone) — full drug profile →
• Placebo

Conditions studied

• Solid Tumors — all drugs for Solid Tumors →

Sponsor

M.D. Anderson Cancer Center — full company profile →

Who can join

18 and older, any sex, with Solid Tumors. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Functional Assessment of Chronic Illness Therapy - Fatigue (FACIT-F) Subscale Scores Primary · Baseline to Day 15

FACIT Fatigue Subscale is a short, 13-item, easy to administer tool that measures an individual's level of fatigue during their usual daily activities over the past week. The level of fatigue is measured on a four point Likert scale (4 = not at all fatigued to 0 = very much fatigued). The total score range is from 0-52. The higher the score, the lower the fatigue level. It was measured as change in symptom score from Baseline to Day 15.

Group	Value	95% CI
Intervention Group (Dexamethasone)	9	± 10.3
(Control Group) Placebo	3.1	± 9.59

Edmonton Symptom Assessment System (ESAS) Pain Secondary · Baseline to day 15

ESAS was used to assess 10 symptoms commonly experienced by patients with cancer during the previous 24 hour. The severity of each symptom was rated on a numeric scale of 0 to 10 (0, no symptoms; 10, worst possible severity). Higher the score higher the severity of the symptom is. It was measured as change in symptom score from Baseline to Day 15.

Group	Value	95% CI
Intervention Group (Dexamethasone)	-1.35	± 3.11
(Control Group) Placebo	-0.17	± 2.66

Edmonton Symptom Assessment System (ESAS) Nausea Secondary · Baseline to Day 15

ESAS was used to assess 10 symptoms commonly experienced by patients with cancer during the previous 24 hour. The severity of each symptom was rated on a numeric scale of 0 to 10 (0, no symptoms; 10, worst possible severity). Higher the score higher the severity of the symptom is. It was measured as change in symptom score from Baseline to Day 15

Group	Value	95% CI
Intervention Group (Dexamethasone)	-1.08	± 2.95
(Control Group) Placebo	-0.36	± 3.17

Edmonton Symptom Assessment System (ESAS) Appetite Secondary · Baseline to day 15

ESAS was used to assess 10 symptoms commonly experienced by patients with cancer during the previous 24 hour. The severity of each symptom was rated on a numeric scale of 0 to 10 (0, no symptoms; 10, worst possible severity). Higher the score higher the severity of the symptom is. It was measured as change in symptom score from Baseline to Day 15

Group	Value	95% CI
Intervention Group (Dexamethasone)	-2.19	± 3.78
(Control Group) Placebo	-0.63	± 3.11

Hospital Anxiety and Depression Scale (HADS) Anxiety Secondary · Baseline to day 15

HADS is a self-report rating scale of 14 items on a 4-point Likert scale (range 0-3). It is designed to measure anxiety and depression (7 items for each subscale). The total range is from 0-21. The higher the score, the higher the severity of symptoms. It was measured as change in symptom score from Baseline to Day 15.

Group	Value	95% CI
Intervention Group (Dexamethasone)	-0.66	± 3.45
(Control Group) Placebo	-1	± 3.54

Hospital Anxiety and Depression Scale (HADS) Depression Secondary · Baseline to day 15

HADS is a self-report rating scale of 14 items on a 4-point Likert scale (range 0-3). It is designed to measure anxiety and depression (7 items for each subscale). The total range is from 0-21. The higher the score, the higher the severity of symptoms. It was measured as change in symptom score from Baseline to Day 15.

Group	Value	95% CI
Intervention Group (Dexamethasone)	-1.39	± 3.59
(Control Group) Placebo	-0.31	± 3.9

Adverse events — posted to ClinicalTrials.gov

Time frame: Baseline up to Day 15. Reporting threshold: 1%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

Intervention Group (Dexamethasone)

Serious: 0/43 (0%)

Deaths: 1/43

(Control Group) Placebo

Serious: 0/41 (0%)

Deaths: 1/41

Other adverse events (14 terms — click to expand)

Reaction	System	Intervention Group (Dexame…	(Control Group) Placebo
Pain	Nervous system disorders	—	—
Fatigue	Musculoskeletal and connective tissue disorders	—	—
Insomnia	Nervous system disorders	—	—
Dyspnea	Respiratory, thoracic and mediastinal disorders	—	—
Infection	General disorders	—	—
Edema	General disorders	—	—
Somnolence	Nervous system disorders	—	—
Nausea/Vomiting	Nervous system disorders	—	—
Cough	Respiratory, thoracic and mediastinal disorders	—	—
Dysphagia	Gastrointestinal disorders	—	—
Dizziness	Nervous system disorders	—	—
Neuropathy	Nervous system disorders	—	—
Blurred Vision	Nervous system disorders	—	—
Depression	Nervous system disorders	—	—

Data from ClinicalTrials.gov NCT00489307 adverse events section.

Sponsor's own description

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.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

1. Effects of Dexamethasone and Placebo on Symptom Clusters in Advanced Cancer Patients: A Preliminary Report.
   Yennurajalingam S, Williams JL, Chisholm G, Bruera E. · · 2016 · cited 26× · PMID 26888692 · DOI 10.1634/theoncologist.2014-0260