Can a common steroid ease cancer symptoms? new trial investigates
NCT ID NCT00489307
First seen Jun 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time
Summary
This phase 2 trial tests whether dexamethasone, a steroid, can help control fatigue, pain, nausea, and other symptoms in 132 adults with advanced solid tumors. Participants take the drug or a placebo by mouth twice daily for 14 days. The main goal is to see if symptoms improve, measured by a fatigue questionnaire.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- Dexamethasone (a steroid drug)
- What this could lead to
- If it works, this could provide a short-term option to reduce common symptoms like fatigue and pain in people with advanced cancer.
- What could go wrong
- This is a small, early-phase trial with only 132 participants. Results may not apply to all cancer types, and dexamethasone can have side effects like increased appetite or mood changes.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
-
Phase 2
Tests whether the treatment actually works, and watches for side effects, in a larger group.
- Participants
-
132 people
The number who actually took part.
- Started
-
Feb 2006
- Expected to finish
-
Feb 2028
An estimate. End dates often move.
- Lead sponsor
-
Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
-
18 years and older
- Sex
-
Anyone
- Healthy volunteers
-
Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: 1. 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, in which 0= no symptom, and 10= worst possible symptom, 2. No clinical evidence of cognitive failure as evidenced by Memorial Delirium Assessment Scale (MDAS) score of 13 or less at baseline 3. Must be 18 years of older 4. No longer a candidate for aggressive anticancer therapy-such as receptor blockers (Iressa, etc.) Patients on oral or palliative chemotherapy are eligible for study if approved by primary oncologist prior to inclusion. Patients who are receiving IV chemotherapy are eligible for study if approved by primary oncologist and they have completed 1st line of chemotherapy and are deemed stable by primary oncologist. The PI of this study will obtain and document approval from the primary oncologist in the patient's study documents. 5. Life expectancy =/\> 30 days 6. Must understand and sign written informed consent 7. Patients on topical, or inhaled corticosteroids are eligible for study. If patients have been on oral corticosteroids for \</= 7 days prior to inclusion of study they are eligible for study. Exclusion Criteria: 1. Allergy to Dexamethasone 2. Inability to complete the baseline assessment forms 3. Patients currently taking Megestrol, and not off drug for \> 7 days 4. Anemia as defined as \< 9 hemoglobin 5. Known history of human immunodeficiency virus (HIV) 6. Neutropenia as defined by an absolute neutrophil count (ANC) of \< 1500 cells/mm 7. Patients with a history of diabetes will be excluded. 8. All major surgeries such as thoracotomy etc., that requires wound healing within last 2 weeks 9. Those who are currently receiving oral corticosteroid therapy or who have been on corticosteroid therapy \>/= 8 days prior to study inclusion 10. Sepsis and/or acute, chronic, or ongoing infections
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
-
Lyndon Baines Johnson Hospital
Houston, Texas, 77030, United States
-
University of Texas MD Anderson Cancer Center
Houston, Texas, 77030, United States
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