Houston, Texas 77030


Purpose:

The goal of this clinical research study is to learn about the effects of combining physical activity with dexamethasone to treat fatigue in patients with advanced cancer.


Study summary:

Baseline Tests: If you are found to be eligible to take part in this study, you will have baseline tests after completing the screening questionnaire. The following tests and procedures will be performed: - You will have a physical exam. - Blood (about 1 tablespoon) will be drawn for routine tests. - You will be asked to complete 6 questionnaires. Each questionnaire should take about 5 minutes to complete, for a total of about 30 minutes. The questionnaires contain questions about: - Your emotional and physical well being - Your level of fatigue - Any anxiety and/or depression you may be having - Your quality of life - Any symptoms you may be having - Your sleep habits - You will complete baseline physical activity tests which will last about 30-45 minutes and include the following: - A 30-second chair-stand test. You will sit in chair with your arms across your chest. Then you will be timed as you stand and sit down as quickly as possible for 30 seconds. - A 6-minute walk test. You will be timed while you walk on a 100-foot loop. You will walk 50 feet and then turn and walk back to the beginning. You will do this at a walking speed that feels comfortable and for as many times as you can in 6 minutes. - You will be taught how to do resistance exercises that you will complete at home. Study Groups: You will be randomly assigned (as in the flip of a coin) to 1 of 2 study groups. This is done because no one knows if one study group is better, the same, or worse than the other group. - If you are in Group 1, you will receive higher-dose dexamethasone by mouth twice a day for 7 days. - If you are in Group 2, you will receive lower-dose dexamethasone by mouth twice a day for 7 days. - Both Groups 1 and 2 will perform physical activity for 4 weeks. You will have an equal chance of being assigned to either group. Neither you nor the medical study staff will know which group you are in. If needed for your safety, the study staff will be able to find out which group you are in. Study Drug Administration: After your baseline tests, you will be given a supply of the study drug to take home. Starting the next morning, you will take 1 dexamethasone tablet twice a day by mouth for 7 days. You should take the tablets around 8 o'clock in the morning and 4 o'clock in the afternoon. You should take the tablets with food and a cup (8 ounces) of water. You should store dexamethasone at room temperature. Study Visits: On Days 8 and 15 (+/- 3 days) you will return to the clinic or be called on the phone if you are unable to return to the clinic in person: - You will be asked to complete 6 questionnaires. Each questionnaire should take about 5 minutes to complete, for a total of 30 minutes. The questionnaires contain questions about: - Your emotional and physical well being - Your level of fatigue - Any anxiety and/or depression you may be having - Your quality of life - Any symptoms you may be having - Your sleep habits Physical Activity: You will complete resistance exercises and a walking program at home each week. The goal of the resistance exercises is to help you to go from a seated to standing position by yourself. For the resistance exercises, you will use color-coded tubes that have 3 levels of resistance: light, moderate, or hard. You will move up in resistance as you gain strength. You will begin with 2 sets of 12 repetitions. You will complete these exercises 3 days a week with at least 48 hours between each session. You will also be asked to walk at least 5 days a week for as long as the study staff recommends that you to do so. You will receive a pedometer, a small device that shows you how many steps you have taken. You will also receive an accelerometer, which measures how fast you speed up when you walk. You will be asked to wear the pedometer and the accelerometer for 3 days during the week before each sudy visit. You will also be given a log where you should record the number of steps you take each day. You will receive 1 phone call each week in which you will be asked about your progress and helped with any problems you may be having completing the program. These calls should last about 10-15 minutes each time. Length of Study Participation: You may continue taking the study drug for 7 days. You may continue the physical activity for 4 weeks. You will no longer be able to take the study drug if the disease gets worse, if intolerable side effects occur, or if you are unable to follow study directions. Your participation on the study will be over after you have completed the follow-up visits. Follow-Up Visits: At Day 29 (+/- 3 days) after your last day of physical activity on study, you will return to the clinic for a follow-up visit: - You will have a physical exam. - If not done in the past 15 days, blood (about 1 tablespoon) will be drawn for routine tests. - You will be asked to complete 7 questionnaires. Each questionnaire should take about 5 minutes to complete, for a total of 35 minutes. The questionnaires ask about: - Your emotional and physical well being - Your level of fatigue - Any anxiety and/or depression you may be having - Any symptoms you may be having and drugs you may be taking - Your sleep habits - Your quality of life - Your level of satisfaction with the fatigue treatment you received - You will complete a 30-second chair-stand test and a 6-minute walk test. - You will return the accelerometer and the pedometer to the study staff. One (1) month after the above visit, you will return for another follow up visit. You will complete the same questionnaires and exercise tests as listed above. This is an investigational study. Dexamethasone is FDA approved and commercially available for the treatment of tiredness, pain, and nausea. It is investigational to combine dexamethasone and exercise to treat fatigue in advanced cancer patients. The study doctor can explain how the study drug is designed to work. Up to 70 participants will be enrolled in this study. All will take part at MD Anderson.


Criteria:

Inclusion Criteria: 1. A diagnosis of advanced cancer (defined as metastatic or recurrent) with fatigue >/=4/10 (0-10 scale) on the Edmonton Symptom Assessment Scale (ESAS) 2. The presence of fatigue for at least 2 weeks 3. Normal cognition 4. Hemoglobin >8 g/L within 1 week of enrollment in the study; and a life expectancy of >/=4 months. 5. No evidence of significant anxiety or depression as determined by a total HADS scores of <21 6. Definition of advanced cancer includes those patients who have metastatic or refractory disease according to their treating oncologist 7. Patients must be able to understand, read, write, and speak English or Spanish. Exclusion Criteria: 1. Patients with a history of hypersensitivity to dexamethasone or having any contraindication to physical activity as determined by the treating physician. 2. Reports a fall in the past 30 days 3. Uncontrolled diabetes mellitus as defined by a random blood sugar of >200mg/dl not being monitored by their primary care physician 4. Sepsis and/or acute, chronic, or ongoing infections that are currently being treated with systemic antimicrobials 5. We will exclude patients with current, active Peptic ulcer disease 6. Neutropenia as defined by an absolute neutrophil count (ANC) of < 1000 cells/mm 7. Regular participation in moderate- or vigorous-intensity physical activity for >/=30 minutes at least 5 times a week and strength training for >/=2 days 8. Severe cardiac disease (New York Heart Association functional class III or IV) or coronary artery disease


NCT ID:

NCT02491632


Primary Contact:

Principal Investigator
Sriram Yennu, MD
M.D. Anderson Cancer Center

Sriram Yennu, MD
Phone: 713-792-6085
Email: CR_Study_Registration@mdanderson.org


Backup Contact:

N/A


Location Contact:

Houston, Texas 77030
United States

Clinical Research Operations
Email: CR_Study_Registration@mdanderson.org

Site Status: Recruiting


Data Source: ClinicalTrials.gov

Date Processed: November 22, 2017

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