Solid Tumors
Conditions
Keywords
Advanced Cancer, Solid Tumors, Fatigue, Pain, Nausea, Anorexia, Dexamethasone, Decadron, Placebo
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.
Detailed description
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.
Interventions
DRUGDexamethasone
4 mg PO (by mouth) twice daily x 14 days
DRUGPlacebo
Placebo PO twice daily x 14 days
Sponsors
M.D. Anderson Cancer Center
American Cancer Society, Inc.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Functional Assessment of Chronic Illness Therapy - Fatigue (FACIT-F) Subscale Scores | Baseline to Day 15 | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Edmonton Symptom Assessment System (ESAS) Pain | Baseline to day 15 | 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. |
| Edmonton Symptom Assessment System (ESAS) Nausea | Baseline to Day 15 | 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 |
| Edmonton Symptom Assessment System (ESAS) Appetite | Baseline to day 15 | 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 |
| Hospital Anxiety and Depression Scale (HADS) Anxiety | Baseline to day 15 | 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. |
| Hospital Anxiety and Depression Scale (HADS) Depression | Baseline to day 15 | 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. |
Countries
United States
Contacts
PRINCIPAL_INVESTIGATORSriram Yennurajalingam, MD
M.D. Anderson Cancer Center
Participant flow
Recruitment details
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.
Participants by arm
| Arm | Count |
|---|---|
| Intervention Group (Dexamethasone) Dexamethasone 4 mg orally two times a day for 14 days. | 67 |
| (Control Group) Placebo Placebo by mouth (PO) twice daily for 14 days. | 65 |
| Total | 132 |
Baseline characteristics
| Characteristic | (Control Group) Placebo | Total | Intervention Group (Dexamethasone) |
|---|---|---|---|
| Age, Continuous | 60 years | 60 years | 60.5 years |
| Edmonton Symptom Assessment System (ESAS) ESAS Anxiety | 3.69 score on a scale STANDARD_DEVIATION 2.91 | 3.66 score on a scale STANDARD_DEVIATION 3.08 | 3.64 score on a scale STANDARD_DEVIATION 3.27 |
| Edmonton Symptom Assessment System (ESAS) ESAS Depression | 3.36 score on a scale STANDARD_DEVIATION 3.11 | 3.24 score on a scale STANDARD_DEVIATION 3.13 | 3.13 score on a scale STANDARD_DEVIATION 3.16 |
| Edmonton Symptom Assessment System (ESAS) ESAS Drowsiness | 4.2 score on a scale STANDARD_DEVIATION 2.68 | 4.17 score on a scale STANDARD_DEVIATION 2.94 | 4.14 score on a scale STANDARD_DEVIATION 3.19 |
| Edmonton Symptom Assessment System (ESAS) ESAS Fatigue | 5.14 score on a scale STANDARD_DEVIATION 2.8 | 7.05 score on a scale STANDARD_DEVIATION 1.89 | 7.38 score on a scale STANDARD_DEVIATION 1.89 |
| Edmonton Symptom Assessment System (ESAS) ESAS Nausea | 2.28 score on a scale STANDARD_DEVIATION 2.76 | 2.46 score on a scale STANDARD_DEVIATION 2.74 | 2.64 score on a scale STANDARD_DEVIATION 2.73 |
| Edmonton Symptom Assessment System (ESAS) ESAS Pain | 5.14 score on a scale STANDARD_DEVIATION 2.8 | 5.43 score on a scale STANDARD_DEVIATION 2.63 | 5.72 score on a scale STANDARD_DEVIATION 2.43 |
| Functional Assessment of Chronic Illness Therapy - Fatigue (FACIT-F) FAACT Subscale score | 25.69 score on a scale STANDARD_DEVIATION 8.93 | 24.84 score on a scale STANDARD_DEVIATION 8.58 | 23.91 score on a scale STANDARD_DEVIATION 8.28 |
| Functional Assessment of Chronic Illness Therapy - Fatigue (FACIT-F) FACIT-F Subscale Score | 21.57 score on a scale STANDARD_DEVIATION 9.11 | 19.64 score on a scale STANDARD_DEVIATION 9.98 | 18.4 score on a scale STANDARD_DEVIATION 10.47 |
| Functional Assessment of Chronic Illness Therapy - Fatigue (FACIT-F) FACIT_F- Total score | 77.1 score on a scale STANDARD_DEVIATION 23.83 | 80.85 score on a scale STANDARD_DEVIATION 22.2 | 88.66 score on a scale STANDARD_DEVIATION 19.9 |
| Hospital Anxiety and Depression Scale (HADS) HADS Anxiety score | 7.46 score on a scale STANDARD_DEVIATION 3.9 | 7.46 score on a scale STANDARD_DEVIATION 4.03 | 7.47 score on a scale STANDARD_DEVIATION 4.18 |
| Hospital Anxiety and Depression Scale (HADS) HADS Depression score | 4.22 score on a scale STANDARD_DEVIATION 7.94 | 8.5 score on a scale STANDARD_DEVIATION 3.8 | 9.03 score on a scale STANDARD_DEVIATION 5.72 |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 6 Participants | 7 Participants | 1 Participants |
| Race (NIH/OMB) Black or African American | 10 Participants | 23 Participants | 13 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 49 Participants | 102 Participants | 53 Participants |
| Region of Enrollment United States | 65 participants | 132 participants | 67 participants |
| Sex: Female, Male Female | 28 Participants | 70 Participants | 42 Participants |
| Sex: Female, Male Male | 37 Participants | 62 Participants | 25 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 1 / 43 | 1 / 41 |
| other Total, other adverse events | 18 / 43 | 11 / 41 |
| serious Total, serious adverse events | 0 / 43 | 0 / 41 |
Outcome results
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.
Time frame: Baseline to Day 15
Population: A total of 48 participants were excluded from the analysis for various reasons.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Intervention Group (Dexamethasone) | Functional Assessment of Chronic Illness Therapy - Fatigue (FACIT-F) Subscale Scores | 9 score on a scale | Standard Deviation 10.3 |
| (Control Group) Placebo | Functional Assessment of Chronic Illness Therapy - Fatigue (FACIT-F) Subscale Scores | 3.1 score on a scale | Standard Deviation 9.59 |
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
Time frame: Baseline to day 15
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Intervention Group (Dexamethasone) | Edmonton Symptom Assessment System (ESAS) Appetite | -2.19 score on a scale | Standard Deviation 3.78 |
| (Control Group) Placebo | Edmonton Symptom Assessment System (ESAS) Appetite | -0.63 score on a scale | Standard Deviation 3.11 |
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
Time frame: Baseline to Day 15
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Intervention Group (Dexamethasone) | Edmonton Symptom Assessment System (ESAS) Nausea | -1.08 score on a scale | Standard Deviation 2.95 |
| (Control Group) Placebo | Edmonton Symptom Assessment System (ESAS) Nausea | -0.36 score on a scale | Standard Deviation 3.17 |
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.
Time frame: Baseline to day 15
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Intervention Group (Dexamethasone) | Edmonton Symptom Assessment System (ESAS) Pain | -1.35 score on a scale | Standard Deviation 3.11 |
| (Control Group) Placebo | Edmonton Symptom Assessment System (ESAS) Pain | -0.17 score on a scale | Standard Deviation 2.66 |
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.
Time frame: Baseline to day 15
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Intervention Group (Dexamethasone) | Hospital Anxiety and Depression Scale (HADS) Anxiety | -0.66 score on a scale | Standard Deviation 3.45 |
| (Control Group) Placebo | Hospital Anxiety and Depression Scale (HADS) Anxiety | -1 score on a scale | Standard Deviation 3.54 |
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.
Time frame: Baseline to day 15
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Intervention Group (Dexamethasone) | Hospital Anxiety and Depression Scale (HADS) Depression | -1.39 score on a scale | Standard Deviation 3.59 |
| (Control Group) Placebo | Hospital Anxiety and Depression Scale (HADS) Depression | -0.31 score on a scale | Standard Deviation 3.9 |