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Methylphenidate for Cancer-Related Fatigue: A Pilot N-of-1 Study

7 Years
21 Years
Not Enrolling

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Trial Information

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

Inclusion Criteria:

- Participants must be receiving cancer-directed treatment at Dana-Farber Cancer
Institute/Children's Hospital Boston or have advanced cancer

- 7-21 years old

- Laboratory values as outlined in the protocol

- Negative pregnancy test (for females of childbearing potential only)

- Child and at least one parent/legal guardian has spoken and written knowledge of

- Participant has approximately age-appropriate knowledge of English and is able to
understand and complete the single-item Likert scale for rating fatigue

- Baseline pedsFACIT-F score of 20 or greater

- Able to reliably take a liquid enterally

- Physical examination including measurement of pulse and blood pressure conducted
within the past 14 days

- If the child is on an opioid analgesic, the primary oncologist does not anticipate a
need to increase opioid during the study

- Opioid dose stable for at least 5 days immediately prior to enrollment

- No initiation of or change in the dose of benzodiazepine or other sedative/hypnotic
drug in the week prior to enrollment and no forseeable initiation or change during
the study

- If currently on an SSRI, SNRI, or tricyclic antidepressant, on a stable dose of the
past week

- Participant has telephone access for communication with the study team regarding
potential dose adjustments and can provide telephone number and alterative phone

Exclusion Criteria:

- Participant is regarded by primary oncologist to be at a high likelihood of death
within 30 days

- Diagnosis of brain tumor, metastatic disease to the brain, or current active CNS

- Known history of glaucoma

- Receiving palliative sedation

- Receipt of MPH or any other psychostimulant, alpha-adrenergic medications,
neuroleptics, lithium, monoamine oxidase inhibitors, procarbazine or coumadin in the
14 days prior to enrollment

- Significant GI disturbance that would impair absorption of the drug

- History of alcohol or substance abuse in the subject. Subjects living with a
household member with a history of alcohol or substance abuse may be excluded if the
investigator feels there is a risk of the study medication being abused or diverted

- Documented history of psychotic or bipolar disorder, delirium, major depression,
suicidal ideation, aggressive behavior necessitating psychiatric care, or any other
psychiatric condition requiring urgent psychiatric evaluation or immediate initiation
of pharmacotherapy

- History of tics or Tourette's syndrome

- Prior history of adverse reaction to MPH

- Uncontrolled hypertension

- Cardiomyopathy, serious structural cardiac abnormalities, or history of any of the
following: ventricular arrhythmia, myocardial infarction, rheumatic fever,
spontaneous or unexplained syncope, exercise-induced syncope, or exercise-induced
chest pain.

- Family history of ventricular arrhythmia, a sudden or unexplained event requiring
resuscitation or sudden death under age 30 years, known cardiac arrhythmia,
hypertrophic cardiomyopathy, or dilated cardiomyopathy.

- Concurrent participation in a study that prohibits enrollment on any other trials
involving cancer-directed or symptom-directed therapies, without approval from the
study PI

- Prior or current medical condition that, in the opinion of the PI, could be
exacerbated by MPH

- Pregnant or breastfeeding women

- HIV-positive individuals on combination antiretroviral therapy

- Treatment of fatigue medications or herbal supplements for fatigue during the 14 days
prior to enrollment

Type of Study:


Study Design:

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Supportive Care

Outcome Measure:


Outcome Description:

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.

Outcome Time Frame:

1 year

Safety Issue:


Principal Investigator

Christina Ullrich, MD, MPH

Investigator Role:

Principal Investigator

Investigator Affiliation:

Dana-Farber Cancer Institute/Children's Hospital Boston


United States: Institutional Review Board

Study ID:




Start Date:

July 2010

Completion Date:

August 2014

Related Keywords:

  • Cancer
  • methylphenidate
  • fatigue
  • Fatigue



Dana-Farber Cancer Institute Boston, Massachusetts  02115
Boston Children's Hospital Boston, Massachusetts  02115