Overview

Dexamethasone for Symptom Burden in Advanced Cancer Patients

Status:
Active, not recruiting
Trial end date:
2021-02-01
Target enrollment:
0
Participant gender:
All
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.
Phase:
Phase 2
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
M.D. Anderson Cancer Center
Collaborator:
American Cancer Society, Inc.
Treatments:
BB 1101
Dexamethasone
Dexamethasone 21-phosphate
Dexamethasone acetate
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 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