Methylphenidate for Cancer-Related Fatigue: A Pilot N-of-1 Study
- 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.
Interventional
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Supportive Care
Feasibility
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.
1 year
No
Christina Ullrich, MD, MPH
Principal Investigator
Dana-Farber Cancer Institute/Children's Hospital Boston
United States: Institutional Review Board
10-146
NCT01164956
July 2010
August 2014
Name | Location |
---|---|
Dana-Farber Cancer Institute | Boston, Massachusetts 02115 |
Boston Children's Hospital | Boston, Massachusetts 02115 |