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IRB suspension, did not resume
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This study will look at how dexamethasone and placebo influence radiation fatigue, quality of life and number of treatment days missed during radiation therapy or radiation therapy and chemotherapy for cancer.
Subjects will randomly receive either dexamethasone or placebo and begin the study medication during the midpoint of their radiation treatment. Study medication will be taken for 14 straight days then stopped. Fatigue and quality of life will be measured weekly with short patient completed surveys. The number of breaks taken during radiation treatment will also be tracked. For safety, blood sugar levels will be checked with finger stick blood draws because dexamethasone is known to cause these levels to increase. Study participation will be approximately 3 months.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Arm 1 Placebo | Placebo Comparator | Subjects receiving radiation therapy or radiation and chemotherapy randomly assigned to placebo bid for 14 days |
|
| Arm 2 Dexamethasone | Active Comparator | Subjects receiving radiation therapy or radiation and chemotherapy randomly assigned to dexamethasone 4 mg bid for 14 days |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Dexamethasone | Drug | oral dexamethasone 4 mg bid for 14 days |
|
| Measure | Description | Time Frame |
|---|---|---|
| Fatigue Measured by FACIT-F Version 4 Fatigue Score | To compare the effects of dexamethasone and placebo on radiation fatigue using validated measures | 12 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Quality of Life as Measured by FACIT-F Version 4 Well-Being Score | To determine the effect of dexamethasone on QoL and radiation therapy treatment interruption | 12 weeks |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Sun Yi, MD | University of Arizona | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Arizona | Tucson | Arizona | 85724 | United States |
Study was terminated and data coordinator is no longer in the institution. Sincere efforts were made to gather and report the data, however, no data are available since the study records cannot be located.
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| ID | Title | Description |
|---|---|---|
| FG000 | Arm 1 Placebo | Subjects receiving radiation therapy or radiation and chemotherapy randomly assigned to placebo bid for 14 days Placebo: oral placebo |
| FG001 | Arm 2 Dexamethesone | Subjects receiving radiation therapy or radiation and chemotherapy randomly assigned to dexamethasone 4 mg bid for 14 days Dexamethasone: oral dexamethasone 4 mg bid for 14 days |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
Study was terminated by IRB - attempts made to obtain info were unsuccessful.
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| ID | Title | Description |
|---|---|---|
| BG000 | Arm 1 Placebo | Subjects receiving radiation therapy or radiation and chemotherapy randomly assigned to placebo bid for 14 days Placebo: oral placebo |
| BG001 | Arm 2 Dexamethesone |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical |
| 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 | Fatigue Measured by FACIT-F Version 4 Fatigue Score | To compare the effects of dexamethasone and placebo on radiation fatigue using validated measures | Data were collected but could not be analyzed. Study terminated by IRB and any data that were gathered, are lost. No data are available for this assessment. | Posted | Count of Participants | Participants | 12 weeks |
|
Data unavailable; study terminated. Good faith attempts made to locate any data have been unsuccessful.
Data unavailable; study terminated. Good faith attempts made to locate any data have been unsuccessful.
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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 | Arm 1 Placebo | Subjects receiving radiation therapy or radiation and chemotherapy randomly assigned to placebo bid for 14 days Placebo: oral placebo |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Sun K. Yi | University of Arizona | (520) 694-7236 | sunkyi@email.arizona.edu |
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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 | Mar 17, 2017 | Apr 22, 2019 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D006258 | Head and Neck Neoplasms |
| D002289 | Carcinoma, Non-Small-Cell Lung |
| D009369 | Neoplasms |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D002283 | Carcinoma, Bronchogenic |
| D001984 | Bronchial Neoplasms |
| D008175 | Lung Neoplasms |
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| ID | Term |
|---|---|
| D003907 | Dexamethasone |
| D000305 | Adrenal Cortex Hormones |
| ID | Term |
|---|---|
| D011246 | Pregnadienetriols |
| D011245 | Pregnadienes |
| D011278 | Pregnanes |
| D013256 | Steroids |
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| Placebo | Drug | oral placebo |
|
Subjects receiving radiation therapy or radiation and chemotherapy randomly assigned to dexamethasone 4 mg bid for 14 days
Dexamethasone: oral dexamethasone 4 mg bid for 14 days
| BG002 | Total | Total of all reporting groups |
|
| Age, Continuous |
| Sex: Female, Male |
|
| Race (NIH/OMB) |
|
| Region of Enrollment | participants |
|
|
|
| Secondary | Quality of Life as Measured by FACIT-F Version 4 Well-Being Score | To determine the effect of dexamethasone on QoL and radiation therapy treatment interruption | Data were collected but could not be analyzed. Study terminated by IRB and any data that were gathered, are lost. No data are available for this assessment. | Posted | 12 weeks |
|
|
| 0 |
| 0 |
| 0 |
| 0 |
| 0 |
| 0 |
| EG001 | Arm 2 Dexamethesone | Subjects receiving radiation therapy or radiation and chemotherapy randomly assigned to dexamethasone 4 mg bid for 14 days Dexamethasone: oral dexamethasone 4 mg bid for 14 days | 0 | 0 | 0 | 0 | 0 | 0 |
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| D012142 |
| Respiratory Tract Neoplasms |
| D013899 | Thoracic Neoplasms |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D000072473 |
| Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |
| D013259 | Steroids, Fluorinated |
| D006728 | Hormones |
| D006730 | Hormones, Hormone Substitutes, and Hormone Antagonists |