Dexamethasone for Symptom Burden in Advanced Cancer Patients
Condition: Solid Tumors
Intervention: Dexamethasone; Placebo
Intervention description: 4 mg PO (by mouth) twice daily x 14 days; Placebo PO twice daily x 14 days
Intervention MeSH terms: Dexamethasone
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Enrollment: 132.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Advanced Cancer; Solid Tumors; Fatigue; Pain; Nausea; Anorexia; Dexamethasone; Decadron; Placebo

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 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