Patient Controlled Administration of Methylphenidate for Cancer Related Fatigue - PRN Methylphenidate
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|ClinicalTrials.gov Identifier: NCT02361125|
Recruitment Status : Active, not recruiting
First Posted : February 11, 2015
Last Update Posted : May 13, 2019
|Condition or disease||Intervention/treatment||Phase|
|Fatigue||Drug: Methylphenidate Behavioral: Fatigue Evaluations||Phase 1|
Fatigue is a major problem in cancer patients. Methylphenidate is a drug currently FDA approved for the treatment of attention deficit disorder and narcolepsy (sleep disorder). Methylphenidate has shown a benefit in improving thinking and decreasing drowsiness and pain in cancer patients taking opioids (pain killers). Methylphenidate has also shown a rapid response in treating depression.
Participants in this study will at first have an evaluation of their fatigue, ability to sleep, and they will answer a set of general symptom questions. It will take about 20 minutes to complete the evaluation. Participants will have a blood test called TSH (thyroid-stimulating hormone) performed to rule out the possibility of thyroid dysfunction as cause of fatigue.
The study will last for 7 days. Participants will be able to take up to four methylphenidate tablets a day on an as needed basis for fatigue. Participants will keep a daily diary where they will record their fatigue rating (0-10) before and 2 hours after taking methylphenidate. The research nurse will contact participants daily by phone (in person for in-patients) to make sure the daily diary is being filled out, to ask about side effects of treatment, and to ask participants to rate their fatigue at four times during the past day and about any possible causes of fatigue.
On the 7th day of treatment, participants will be evaluated in the palliative care clinic or by telephone. Evaluation of fatigue, ability to sleep, and general symptoms along with an evaluation of side effects and effectiveness of methylphenidate will be performed. The evaluation will take about 15 minutes to complete. If participants develop intolerable side effects while on study, the medication will be stopped and they will be removed from the study.
If participants find the drug beneficial and wish to continue taking it, they will be given a prescription for methylphenidate and can be followed as an outpatient in the palliative care clinic. Participants who choose to continue the medication will be evaluated at the end of 4 weeks for fatigue, ability to sleep, and general symptoms along with an evaluation of side effects and effectiveness by phone or in the clinic. The evaluation will take about 15 minutes to complete.
This is an investigational study. The use methylphenidate is investigational. A total of 36 patients will take part in this study. All will be enrolled at UTMDACC.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||31 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Patient Controlled Administration of Methylphenidate for Cancer Related Fatigue|
|Actual Study Start Date :||August 1, 2002|
|Estimated Primary Completion Date :||August 2019|
|Estimated Study Completion Date :||August 2020|
Participants given a 7 day supply of 5 mg methylphenidate tablets (to take a maximum of 20 mg/day, for total of 28 tablets). Directions for use are to take one 5 mg tablet by mouth as needed every 2 hours for participant described significant fatigue (maximum of 4 tablets/day).
Evaluation of fatigue, ability to sleep, and general symptom questions at baseline visit, daily while on study drug, and on seventh day of treatment.
5 mg tablet by mouth as needed every 2 hours for participant described significant fatigue. Participants to take a maximum of 20 mg/day, for total of 28 tablets for 7 days.
Behavioral: Fatigue Evaluations
Participants to have evaluation of their fatigue, ability to sleep, and will answer a set of general symptom questions at baseline visit, daily while on study drug, and on seventh day of treatment.
- Fatigue Measurement on a 10-point scale [ Time Frame: 7 days ]Primary endpoint is fatigue as measured on a 10-point scale. An average 2-point reduction in fatigue from before to 2 hours after taking methylphenidate considered a clinical success.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02361125
|United States, Texas|
|University of Texas MD Anderson Cancer Center|
|Houston, Texas, United States, 77030|
|Principal Investigator:||Eduardo Bruera, MD||M.D. Anderson Cancer Center|