Methylphenidate for Cancer-Related Fatigue

This study has been terminated.
(Insufficient Resources)
Sponsor:
Collaborator:
Children's Hospital Boston
Information provided by (Responsible Party):
Christina K. Ullrich, MD, MPH, Dana-Farber Cancer Institute
ClinicalTrials.gov Identifier:
NCT01164956
First received: July 6, 2010
Last updated: April 25, 2016
Last verified: April 2016
  Purpose
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 for individual clinical decision making and for clinical trials in symptom management in pediatric oncology patients.

Condition Intervention
Cancer
Drug: methylphenidate

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Supportive Care
Official Title: Methylphenidate for Cancer-Related Fatigue: A Pilot N-of-1 Study

Resource links provided by NLM:


Further study details as provided by Dana-Farber Cancer Institute:

Primary Outcome Measures:
  • Feasibility [ Time Frame: 1 year ] [ Designated as safety issue: No ]
    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.


Secondary Outcome Measures:
  • MPH efficacy [ Time Frame: 1 year ] [ Designated as safety issue: No ]
    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.


Enrollment: 3
Study Start Date: July 2010
Study Completion Date: March 2016
Primary Completion Date: March 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
arm 1
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
Drug: methylphenidate
taken orally
Other Name: MPH
arm 2
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"
Drug: methylphenidate
taken orally
Other Name: MPH

Detailed Description:
  • 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.
  Eligibility

Ages Eligible for Study:   7 Years to 21 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01164956

Locations
United States, Massachusetts
Boston Children's Hospital
Boston, Massachusetts, United States, 02115
Dana-Farber Cancer Institute
Boston, Massachusetts, United States, 02215
Sponsors and Collaborators
Dana-Farber Cancer Institute
Children's Hospital Boston
Investigators
Principal Investigator: Christina Ullrich, MD, MPH Dana-Farber Cancer Institute/Children's Hospital Boston
  More Information

Responsible Party: Christina K. Ullrich, MD, MPH, Christina Ullrich, MD, MPH, Dana-Farber Cancer Institute
ClinicalTrials.gov Identifier: NCT01164956     History of Changes
Other Study ID Numbers: 10-146 
Study First Received: July 6, 2010
Last Updated: April 25, 2016
Health Authority: United States: Institutional Review Board

Keywords provided by Dana-Farber Cancer Institute:
methylphenidate
fatigue

Additional relevant MeSH terms:
Methylphenidate
Central Nervous System Stimulants
Dopamine Agents
Dopamine Uptake Inhibitors
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Agents
Neurotransmitter Uptake Inhibitors
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on May 26, 2016