Dexamethasone for Symptom Burden in Advanced Cancer Patients

NCT00489307 | Active Not Recruiting Phase 2 Results DMC FDA Drug

• 3 other identifiers: 2005-0816NCI-2012-01646MRSG-07-001-01-CCE
• Study Type: interventional
• Target: 132
• Locations: 1 country
• Sites: 2

Brief 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.

Conditions

Solid Tumors

Keywords

Advanced Cancer; Solid Tumors; Fatigue; Pain; Nausea; Anorexia; Dexamethasone; Decadron; Placebo

Outcome Measures

Primary Outcomes (1)

• Functional Assessment of Chronic Illness Therapy - Fatigue (FACIT-F) Subscale Scores

  FACIT Fatigue Subscale is a short, 13-item, easy to administer tool that measures an individual's level of fatigue during their usual daily activities over the past week. The level of fatigue is measured on a four point Likert scale (4 = not at all fatigued to 0 = very much fatigued). The total score range is from 0-52. The higher the score, the lower the fatigue level. It was measured as change in symptom score from Baseline to Day 15.

  Baseline to Day 15

Secondary Outcomes (5)

• Edmonton Symptom Assessment System (ESAS) Pain

  Baseline to day 15

• Edmonton Symptom Assessment System (ESAS) Nausea

  Baseline to Day 15

• Edmonton Symptom Assessment System (ESAS) Appetite

  Baseline to day 15

• Hospital Anxiety and Depression Scale (HADS) Anxiety

  Baseline to day 15

• Hospital Anxiety and Depression Scale (HADS) Depression

  Baseline to day 15

Study Arms (2)

Dexamethasone

ACTIVE COMPARATOR

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.

Drug: Dexamethasone

Placebo

PLACEBO COMPARATOR

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.

Drug: Dexamethasone; Drug: Placebo

Interventions

Dexamethasone DRUG

4 mg PO (by mouth) twice daily x 14 days

Also known as: Decadron

Dexamethasone; Placebo

Placebo DRUG

Placebo PO twice daily x 14 days

Placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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,
• No clinical evidence of cognitive failure as evidenced by Memorial Delirium Assessment Scale (MDAS) score of 13 or less at baseline
• Must be 18 years of older
• Life expectancy =/\> 30 days
• Must understand and sign written informed consent

You may not qualify if:

• Allergy to Dexamethasone
• Inability to complete the baseline assessment forms
• Patients currently taking Megestrol, and not off drug for \> 7 days
• Anemia as defined as \< 9 hemoglobin
• Known history of human immunodeficiency virus (HIV)
• Neutropenia as defined by an absolute neutrophil count (ANC) of \< 1500 cells/mm
• Patients with a history of diabetes will be excluded.
• All major surgeries such as thoracotomy etc., that requires wound healing within last 2 weeks
• Sepsis and/or acute, chronic, or ongoing infections

Sponsors & Collaborators

• M.D. Anderson Cancer Center: lead
• American Cancer Society, Inc.: collaborator

Study Sites (2)

Lyndon Baines Johnson Hospital

Houston, Texas, 77030, United States

Location

University of Texas MD Anderson Cancer Center

Houston, Texas, 77030, United States

Location

Related Links

• University of Texas MD Anderson Cancer Center Website

MeSH Terms

Conditions

Fatigue; Pain; Nausea; Anorexia

Interventions

Dexamethasone; Calcium Dobesilate

Condition Hierarchy (Ancestors)

Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Neurologic Manifestations; Signs and Symptoms, Digestive

Intervention Hierarchy (Ancestors)

Pregnadienetriols; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Steroids, Fluorinated; Benzenesulfonates; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Arylsulfonates; Arylsulfonic Acids; Sulfonic Acids; Sulfur Acids; Sulfur Compounds

Results Point of Contact

• Title: Dr. Sriram Yennu, Professor, Palliative Care Med
• Organization: UT MD Anderson Cancer Center

syennu@mdanderson.org

(713) 792-3938

Study Officials

• Sriram Yennurajalingam, MD

  M.D. Anderson Cancer Center

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 19, 2007
• First Posted: June 21, 2007
• Study Start: February 2, 2006
• Primary Completion: February 28, 2021
• Study Completion (Estimated): February 28, 2028
• Last Updated: June 8, 2026
• Results First Posted: December 21, 2021

Record last verified: 2026-05

Locations

US (2)