Status:
TERMINATED
Methylphenidate for Cancer-Related Fatigue
Lead Sponsor:
Dana-Farber Cancer Institute
Collaborating Sponsors:
Boston Children's Hospital
Conditions:
Cancer
Eligibility:
All Genders
7-21 years
Phase:
PHASE1
Brief Summary
The overall aim of this pilot study is to conduct a combined N-of-1 trial (N-1-T) of MPH (methylphenidate) for amelioration of fatigue in children with cancer, and to evaluate the N-1-T design both fo...
Detailed Description
I. To assess the N-1-T as a study design to evaluate a symptom-directed intervention in children with cancer Primary objective -To evaluate the feasibility of conducting an N-1-T to evaluate MPH for...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
July 1 2011
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 1 2013
Estimated Enrollment :
3 Patients enrolled
Trial Details
Trial ID
NCT01164956
Start Date
July 1 2011
End Date
March 1 2013
Last Update
April 26 2019
Active Locations (2)
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1
Boston Children's Hospital
Boston, Massachusetts, United States, 02115
2
Dana-Farber Cancer Institute
Boston, Massachusetts, United States, 02215