Clinical trial · Interventional
Dexamethasone for Symptom Burden in Advanced Cancer Patients
The Effect of Dexamethasone on Symptoms in Patients With Advanced Cancer
NCT00489307CI-TRIAL-00113993active not recruitingPhase 2Results postedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Solid Tumors | Solid Neoplasm | CURATED_BROADER | 0.80 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Dexamethasone | Drug | Dexamethasone | ALIAS |
| Placebo | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- ACTIVE_COMPARATOR
- label
- Dexamethasone
- description
- 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.
- interventionNames
- Drug: Dexamethasone
- type
- PLACEBO_COMPARATOR
- label
- Placebo
- description
- 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.
- interventionNames
- Drug: Dexamethasone
- Drug: Placebo
Primary outcomes (1)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available
No reference posted for this study.