Methylphenidate for Cancer-Related Fatigue

- 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.

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
English

- 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
number

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
leukemia

- 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