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| ID | Type | Description | Link |
|---|---|---|---|
| NCI-2012-01646 | Registry Identifier | NCI CTRP | |
| MRSG-07-001-01-CCE | Other Grant/Funding Number | American Cancer Society |
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| Name | Class |
|---|---|
| American Cancer Society, Inc. | OTHER |
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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.
Dexamethasone decreases inflammation and also suppresses the immune system.
If you are found to be eligible for this study, you will be randomly assigned (as in the toss of a coin) to receive either dexamethasone or a placebo by mouth in the morning and at night with food every day for 14 days. A placebo is a substance that looks like the study drug but which has no active ingredients. You will have an equal chance of being placed in either of the 2 groups. You, the medical staff, and researchers will not know to which group you have been assigned.
Beginning on Day 15 [± 3 days], regardless of if you were assigned to the dexamethasone or placebo group during the first 14 days, you will begin receiving the dexamethasone. On Days 15-21, you will receive dexamethasone 2 times a day. On Days 22-28 you will continue to take dexamethasone 2 times a day, but it will be at a lower dose level.
If you develop intolerable side effects while on this study, the medication will be stopped and you will be removed from the study.
You will be asked to return to the outpatient clinic on Days 8 [± 3 days], 15 [± 3 days] , 22 [± 3 days], and 29 [± 3 days] to answer a questionnaire about your cancer diagnosis, the medication you are taking, and the symptoms you are having (for example, pain, fatigue, nausea, appetite problems, sleep problems, depression, and your overall sense of well-being). The questionnaire will take approximately 30 minutes to complete. Blood (about 1 tablespoon) will be drawn to measure protein levels and to check the iron level in your blood. If you are unable to return to the clinic on days 8, 15, 22, or 29; the assessments will be done by the research nurse by phone; the blood work will not be done.
You will be considered off-study on Day 29 [ ± 3 days]. All study patients will have a 2 week follow-up on day 43 [± 3 days] after study drug has been discontinued, for safety and toxicity assessments. If you are unable to return to the clinic on day 43, the research nurse will do the safety and toxicity assessment by phone.
This is an investigational study. Dexamethasone has been approved by the FDA and is a commercially available drug. It is FDA approved at this dose level. Its use in this study, for this purpose, is investigational. About 160 patients will take part in this study. Up to 110 will be enrolled at the University of Texas (UT) MD Anderson Cancer Center. The other sites participating in this study are Lyndon Baines Johnson [LBJ] breast oncology clinic Houston Texas, and Four Seasons Hospice in Flat Rock, North Carolina.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Dexamethasone | Drug | 4 mg PO (by mouth) twice daily x 14 days |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Edmonton Symptom Assessment System (ESAS) Pain | ESAS was used to assess 10 symptoms commonly experienced by patients with cancer during the previous 24 hour. The severity of each symptom was rated on a numeric scale of 0 to 10 (0, no symptoms; 10, worst possible severity). Higher the score higher the severity of the symptom is. It was measured as change in symptom score from Baseline to Day 15. | Baseline to day 15 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Sriram Yennurajalingam, MD | M.D. Anderson Cancer Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Lyndon Baines Johnson Hospital | Houston | Texas | 77030 | United States | ||
| University of Texas MD Anderson Cancer Center |
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| Label | URL |
|---|---|
| University of Texas MD Anderson Cancer Center Website | View source |
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Patients with advanced cancer with >= three Cancer related fatigue symptoms (ie, fatigue, pain, nausea, loss of appetite, depression, anxiety, or sleep disturbance) >= 4 of 10 on the Edmonton Symptom Assessment Scale (ESAS) were eligible.
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| ID | Title | Description |
|---|---|---|
| FG000 | Intervention Group (Dexamethasone) | Dexamethasone 4 mg orally two times a day for 14 days. |
| FG001 | (Control Group) Placebo | Placebo by mouth (PO) twice daily for 14 days. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Intervention Group (Dexamethasone) | Dexamethasone 4 mg orally two times a day for 14 days. |
| BG001 | (Control Group) Placebo | Placebo by mouth (PO) twice daily for 14 days. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | A total of 48 participants were excluded from the analysis for various reasons. | Posted | Mean | Standard Deviation | score on a scale | Baseline to Day 15 |
|
Baseline up to Day 15
Grading of adverse events as per National Cancer Institute Common Toxicity Criteria (version 3.0).
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Intervention Group (Dexamethasone) | Dexamethasone 4 mg orally two times a day for 14 days. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Pain | Nervous system disorders | CTCAE (4.0) | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Sriram Yennu, Professor, Palliative Care Med | UT MD Anderson Cancer Center | (713) 792-3938 | syennu@mdanderson.org |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Apr 5, 2011 | Oct 13, 2021 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D005221 | Fatigue |
| D010146 | Pain |
| D009325 | Nausea |
| D000855 | Anorexia |
| ID | Term |
|---|---|
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D009461 | Neurologic Manifestations |
| D012817 | Signs and Symptoms, Digestive |
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| ID | Term |
|---|---|
| D003907 | Dexamethasone |
| D002123 | Calcium Dobesilate |
| ID | Term |
|---|---|
| D011246 | Pregnadienetriols |
| D011245 | Pregnadienes |
| D011278 | Pregnanes |
| D013256 | Steroids |
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| Placebo | Drug | Placebo PO twice daily x 14 days |
|
| Edmonton Symptom Assessment System (ESAS) Nausea | ESAS was used to assess 10 symptoms commonly experienced by patients with cancer during the previous 24 hour. The severity of each symptom was rated on a numeric scale of 0 to 10 (0, no symptoms; 10, worst possible severity). Higher the score higher the severity of the symptom is. It was measured as change in symptom score from Baseline to Day 15 | Baseline to Day 15 |
| Edmonton Symptom Assessment System (ESAS) Appetite | ESAS was used to assess 10 symptoms commonly experienced by patients with cancer during the previous 24 hour. The severity of each symptom was rated on a numeric scale of 0 to 10 (0, no symptoms; 10, worst possible severity). Higher the score higher the severity of the symptom is. It was measured as change in symptom score from Baseline to Day 15 | Baseline to day 15 |
| Hospital Anxiety and Depression Scale (HADS) Anxiety | HADS is a self-report rating scale of 14 items on a 4-point Likert scale (range 0-3). It is designed to measure anxiety and depression (7 items for each subscale). The total range is from 0-21. The higher the score, the higher the severity of symptoms. It was measured as change in symptom score from Baseline to Day 15. | Baseline to day 15 |
| Hospital Anxiety and Depression Scale (HADS) Depression | HADS is a self-report rating scale of 14 items on a 4-point Likert scale (range 0-3). It is designed to measure anxiety and depression (7 items for each subscale). The total range is from 0-21. The higher the score, the higher the severity of symptoms. It was measured as change in symptom score from Baseline to Day 15. | Baseline to day 15 |
| Houston |
| Texas |
| 77030 |
| United States |
| Physician Decision |
|
| Withdrawal by Subject |
|
| Hospitalization unrelated to treatment |
|
| Surgery after assignment |
|
| Did not fill up the forms |
|
| Patient or family refusal |
|
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Functional Assessment of Chronic Illness Therapy - Fatigue (FACIT-F) | FACIT Fatigue Subscale (13- item tool), FAACT Subscale (12-item tool) and FACIT-F Total Score (40-item tool). All of them asses self reported fatigue. All items in the above 3 tools are measured on a 4 point Likert scale (4 = not at all fatigued to 0 = very much fatigued). The higher the score, the lower the fatigue level. FACIT Fatigue Subscale total score range is 0-52. FAACT Subscale total score range is 0-48. FACIT-F Total Score range is 0-160. | Mean | Standard Deviation | score on a scale |
|
| Hospital Anxiety and Depression Scale (HADS) | The HADS questionnaire has seven items each for depression and anxiety subscales. Scoring for each item ranges from zero to three, with three denoting highest anxiety or depression level. The total subscale score ranges from 0-21. A total subscale score of >8 points out of a possible 21 denotes considerable symptoms of anxiety or depression. | Mean | Standard Deviation | score on a scale |
|
| Edmonton Symptom Assessment System (ESAS) | The severity at the time of assessment of each symptom is rated from 0 to 10 on a numerical scale, 0 meaning that the symptom is absent and 10 that it is of the worst possible severity | Mean | Standard Deviation | score on a scale |
|
| (Control Group) Placebo |
Placebo by mouth (PO) twice daily for 14 days. |
|
|
| Secondary | Edmonton Symptom Assessment System (ESAS) Pain | ESAS was used to assess 10 symptoms commonly experienced by patients with cancer during the previous 24 hour. The severity of each symptom was rated on a numeric scale of 0 to 10 (0, no symptoms; 10, worst possible severity). Higher the score higher the severity of the symptom is. It was measured as change in symptom score from Baseline to Day 15. | Posted | Mean | Standard Deviation | score on a scale | Baseline to day 15 |
|
|
|
| Secondary | Edmonton Symptom Assessment System (ESAS) Nausea | ESAS was used to assess 10 symptoms commonly experienced by patients with cancer during the previous 24 hour. The severity of each symptom was rated on a numeric scale of 0 to 10 (0, no symptoms; 10, worst possible severity). Higher the score higher the severity of the symptom is. It was measured as change in symptom score from Baseline to Day 15 | Posted | Mean | Standard Deviation | score on a scale | Baseline to Day 15 |
|
|
|
| Secondary | Edmonton Symptom Assessment System (ESAS) Appetite | ESAS was used to assess 10 symptoms commonly experienced by patients with cancer during the previous 24 hour. The severity of each symptom was rated on a numeric scale of 0 to 10 (0, no symptoms; 10, worst possible severity). Higher the score higher the severity of the symptom is. It was measured as change in symptom score from Baseline to Day 15 | Posted | Mean | Standard Deviation | score on a scale | Baseline to day 15 |
|
|
|
| Secondary | Hospital Anxiety and Depression Scale (HADS) Anxiety | HADS is a self-report rating scale of 14 items on a 4-point Likert scale (range 0-3). It is designed to measure anxiety and depression (7 items for each subscale). The total range is from 0-21. The higher the score, the higher the severity of symptoms. It was measured as change in symptom score from Baseline to Day 15. | Posted | Mean | Standard Deviation | score on a scale | Baseline to day 15 |
|
|
|
| Secondary | Hospital Anxiety and Depression Scale (HADS) Depression | HADS is a self-report rating scale of 14 items on a 4-point Likert scale (range 0-3). It is designed to measure anxiety and depression (7 items for each subscale). The total range is from 0-21. The higher the score, the higher the severity of symptoms. It was measured as change in symptom score from Baseline to Day 15. | Posted | Mean | Standard Deviation | score on a scale | Baseline to day 15 |
|
|
|
| 1 |
| 43 |
| 0 |
| 43 |
| 18 |
| 43 |
| EG001 | (Control Group) Placebo | Placebo by mouth (PO) twice daily for 14 days. | 1 | 41 | 0 | 41 | 11 | 41 |
| Insomnia | Nervous system disorders | CTCAE (4.0) | Systematic Assessment |
|
| Fatigue | Musculoskeletal and connective tissue disorders | CTCAE (4.0) | Systematic Assessment |
|
| Infection | General disorders | CTCAE (4.0) | Systematic Assessment |
|
| Cough | Respiratory, thoracic and mediastinal disorders | CTCAE (4.0) | Systematic Assessment |
|
| Dysphagia | Gastrointestinal disorders | CTCAE (4.0) | Systematic Assessment |
|
| Dizziness | Nervous system disorders | CTCAE (4.0) | Systematic Assessment |
|
| Dyspnea | Respiratory, thoracic and mediastinal disorders | CTCAE (4.0) | Systematic Assessment |
|
| Edema | General disorders | CTCAE (4.0) | Systematic Assessment |
|
| Neuropathy | Nervous system disorders | CTCAE (4.0) | Systematic Assessment |
|
| Somnolence | Nervous system disorders | CTCAE (4.0) | Systematic Assessment |
|
| Nausea/Vomiting | Nervous system disorders | CTCAE (4.0) | Systematic Assessment |
|
| Blurred Vision | Nervous system disorders | CTCAE (4.0) | Systematic Assessment |
|
| Depression | Nervous system disorders | CTCAE (4.0) | Systematic Assessment |
|
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| D000072473 |
| Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |
| D013259 | Steroids, Fluorinated |
| D001557 | Benzenesulfonates |
| D001555 | Benzene Derivatives |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
| D001190 | Arylsulfonates |
| D017739 | Arylsulfonic Acids |
| D013451 | Sulfonic Acids |
| D013456 | Sulfur Acids |
| D013457 | Sulfur Compounds |