Methylphenidate for Cancer-Related Fatigue
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT01164956|
Recruitment Status : Terminated (Insufficient Resources)
First Posted : July 19, 2010
Last Update Posted : April 27, 2016
|Condition or disease||Intervention/treatment||Phase|
|Cancer||Drug: methylphenidate||Not Applicable|
- Because no one knows which of the study options are best, participants will receive liquid MPH on some days and a placebo on other days. We will compare how the participant feels on MPH days with how they feel on placebo days to determine whether MPH makes a difference.
- Participants will take 3 days of MPH in a row and 3 days of placebo in a row, which will make up one study treatment pair. Participants will receive a total of 3 study treatment pairs.
- On the days that the participant takes the MPH or placebo, they will answer one question asking to rate their fatigue. They will also be asked to complete study drug diary as well as a sleep diary.
- After every 3 days of either MPH or placebo, the participant will complete an additional survey about their fatigue, other symptoms, and possible side effects from MPH.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||3 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|Primary Purpose:||Supportive Care|
|Official Title:||Methylphenidate for Cancer-Related Fatigue: A Pilot N-of-1 Study|
|Study Start Date :||July 2010|
|Actual Primary Completion Date :||March 2016|
|Actual Study Completion Date :||March 2016|
no compano comparison arm, participants serve as their own controls; methylphenidate and placebo are administered in blocks, with one then the other administered in one block. There are 4 blocks, Order of the two treatments within a block is random. There are therefore theoretically 16 potential "arms"rison arm, participants serve as their own controls
Other Name: MPH
no comparison arm, participants serve as their own controls; methylphenidate and placebo are administered in blocks, with one then the other administered in one block. There are 4 blocks, Order of the two treatments within a block is random. There are therefore theoretically 16 potential "arms"
Other Name: MPH
- Feasibility [ Time Frame: 1 year ]The feasibility of conducting an N-1-T to evaluate MPH for cancer-related fatigue will be determined by the completion rate of two MPH-placebo pairs.
- MPH efficacy [ Time Frame: 1 year ]The effect of MPH on cancer-related fatigue in children will be evaluated by the mean pedsFACIT-F score obtained with MPH treatment as compared with the mean pedsFACIT-F score obtained with placebo.
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): NCT01164956
|United States, Massachusetts|
|Boston Children's Hospital|
|Boston, Massachusetts, United States, 02115|
|Dana-Farber Cancer Institute|
|Boston, Massachusetts, United States, 02215|
|Principal Investigator:||Christina Ullrich, MD, MPH||Dana-Farber Cancer Institute/Children's Hospital Boston|