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Active Not Recruiting
NCT00489307
Dexamethasone for Symptom Burden in Advanced Cancer Patients
Conditions: Solid Tumors
Sex: All
Ages: 18 Years – N/A
Healthy volunteers: No
Phase: PHASE2
Enrollment: 132
Sponsor: M.D. Anderson Cancer Center
Location: Lyndon Baines Johnson Hospital Houston Texas
Summary
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.
Eligibility Criteria
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
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
Source: ClinicalTrials.gov (NCT00489307). StuddyBuddy aggregates publicly available trial information.