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Trial record 77 of 439 for:    Methylphenidate

Methylphenidate for Cancer-Related Fatigue

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ClinicalTrials.gov Identifier: NCT01164956
Recruitment Status : Terminated (Insufficient Resources)
First Posted : July 19, 2010
Results First Posted : April 26, 2019
Last Update Posted : April 26, 2019
Sponsor:
Collaborator:
Boston Children’s Hospital
Information provided by (Responsible Party):
Christina K. Ullrich, MD, MPH, Dana-Farber Cancer Institute

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 for individual clinical decision making and for clinical trials in symptom management in pediatric oncology patients. 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.

Condition or disease Intervention/treatment Phase
Cancer Drug: methylphenidate Other: Placebo Phase 1

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 cancer-related fatigue in children as a group

Secondary objectives

  • To evaluate the ability of the N-1-T to assess efficacy of MPH for an individual subject statistically and clinically definite answer (regarding the ability of MPH to reduce fatigue)
  • To explore subject/family and oncologist perspectives on N1T participation
  • To examine in a preliminary fashion whether there are patient, family, disease or study-related factors that are associated with attrition to help guide future large-scale N1Ts

II. To evaluate MPH for treatment of cancer-related fatigue and related symptoms in children

Primary objective

-To evaluate the effect of MPH on cancer-related fatigue in children based on various assessments including pedsFACIT-F and a unidimensional single-item Likert scale for measuring fatigue

Secondary objective

-To assess the side effect profile of MPH for fatigue in children with cancer

III. To evaluate fatigue assessment tools Primary objective

-To evaluate correlation between fatigue scores


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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 3 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: The N-of-1 design randomized participants to 3 potential treatment pairs; Each pair incorporated the 2 drugs under investigation but with different sequence: Methylphenidate then Placebo or Placebo then Methylphenidate. With this design, there are 8 potential permutations/arms.
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Supportive Care
Official Title: Methylphenidate for Cancer-Related Fatigue: A Pilot N-of-1 Study
Actual Study Start Date : July 2011
Actual Primary Completion Date : March 2013
Actual Study Completion Date : March 2013

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Fatigue

Arm Intervention/treatment
Experimental: M-P, P-M, M-P
Participants were randomized to receive 3 treatment pairs of placebo (P) then methylphenidate (M) or M then P. Each M or P was given daily for 3 days and therefore treatment duration was 18 days over 3 treatment pairs. M or P was administered orally at a starting dose of 0.3 mg/kg/dose. For participants > 40 kg, the maximum of dose in the first treatment pair was 12.5 mg per dose. Dose escalation to maximum 0.5 mg/kg/dose was permitted.
Drug: methylphenidate
Other Names:
  • MPH
  • Ritalin
  • Methylin
  • Concerta

Other: Placebo
Experimental: P-M, P-M, M-P
Participants were randomized to receive 3 treatment pairs of placebo (P) then methylphenidate (M) or M then P. Each M or P was given daily for 3 days and therefore treatment duration was 18 days over 3 treatment pairs. M or P was administered orally at a starting dose of 0.3 mg/kg/dose. For participants > 40 kg, the maximum of dose in the first treatment pair was 12.5 mg per dose. Dose escalation to maximum 0.5 mg/kg/dose was permitted.
Drug: methylphenidate
Other Names:
  • MPH
  • Ritalin
  • Methylin
  • Concerta

Other: Placebo
Experimental: P-M, M-P, M-P
Participants were randomized to receive 3 treatment pairs of placebo (P) then methylphenidate (M) or M then P. Each M or P was given daily for 3 days and therefore treatment duration was 18 days over 3 treatment pairs. M or P was administered orally at a starting dose of 0.3 mg/kg/dose. For participants > 40 kg, the maximum of dose in the first treatment pair was 12.5 mg per dose. Dose escalation to maximum 0.5 mg/kg/dose was permitted.
Drug: methylphenidate
Other Names:
  • MPH
  • Ritalin
  • Methylin
  • Concerta

Other: Placebo
Experimental: M-P, M-P, M-P
Participants were randomized to receive 3 treatment pairs of placebo (P) then methylphenidate (M) or M then P. Each M or P was given daily for 3 days and therefore treatment duration was 18 days over 3 treatment pairs. M or P was administered orally at a starting dose of 0.3 mg/kg/dose. For participants > 40 kg, the maximum of dose in the first treatment pair was 12.5 mg per dose. Dose escalation to maximum 0.5 mg/kg/dose was permitted.
Drug: methylphenidate
Other Names:
  • MPH
  • Ritalin
  • Methylin
  • Concerta

Other: Placebo
Experimental: M-P, P-M, P-M
Participants were randomized to receive 3 treatment pairs of placebo (P) then methylphenidate (M) or M then P. Each M or P was given daily for 3 days and therefore treatment duration was 18 days over 3 treatment pairs. M or P was administered orally at a starting dose of 0.3 mg/kg/dose. For participants > 40 kg, the maximum of dose in the first treatment pair was 12.5 mg per dose. Dose escalation to maximum 0.5 mg/kg/dose was permitted.
Drug: methylphenidate
Other Names:
  • MPH
  • Ritalin
  • Methylin
  • Concerta

Other: Placebo
Experimental: M-P, M-P, P-M
Participants were randomized to receive 3 treatment pairs of placebo (P) then methylphenidate (M) or M then P. Each M or P was given daily for 3 days and therefore treatment duration was 18 days over 3 treatment pairs. M or P was administered orally at a starting dose of 0.3 mg/kg/dose. For participants > 40 kg, the maximum of dose in the first treatment pair was 12.5 mg per dose. Dose escalation to maximum 0.5 mg/kg/dose was permitted.
Drug: methylphenidate
Other Names:
  • MPH
  • Ritalin
  • Methylin
  • Concerta

Other: Placebo
Experimental: P-M, P-M, P-M
Participants were randomized to receive 3 treatment pairs of placebo (P) then methylphenidate (M) or M then P. Each M or P was given daily for 3 days and therefore treatment duration was 18 days over 3 treatment pairs. M or P was administered orally at a starting dose of 0.3 mg/kg/dose. For participants > 40 kg, the maximum of dose in the first treatment pair was 12.5 mg per dose. Dose escalation to maximum 0.5 mg/kg/dose was permitted.
Drug: methylphenidate
Other Names:
  • MPH
  • Ritalin
  • Methylin
  • Concerta

Other: Placebo
Experimental: P-M, M-P, P-M
Participants were randomized to receive 3 treatment pairs of placebo (P) then methylphenidate (M) or M then P. Each M or P was given daily for 3 days and therefore treatment duration was 18 days over 3 treatment pairs. M or P was administered orally at a starting dose of 0.3 mg/kg/dose. For participants > 40 kg, the maximum of dose in the first treatment pair was 12.5 mg per dose. Dose escalation to maximum 0.5 mg/kg/dose was permitted.
Drug: methylphenidate
Other Names:
  • MPH
  • Ritalin
  • Methylin
  • Concerta

Other: Placebo



Primary Outcome Measures :
  1. Completion Rate of Two Treatment Pairs Using the N-1-T Design [ Time Frame: 18 days ]
    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 :
  1. Rate of Receiving Clinically Definite Answer Regarding the Ability of Experimental Treatment to Reduce Fatigue Using the N-1-T Design [ Time Frame: 18 days ]
    Efficacy of the N-1-T design is defined as patient providing a clinically definite answer regarding the ability of MPH to reduce fatigue.Based on the definition of the outcome being evaluated, aggregation of data for all participants is appropriate.

  2. Change Over Treatment Pairs in pedsFACIT-F Score [ Time Frame: The pedsFACIT-Fwas administered at baseline and at the end of each treatment pair (TP) and related change in score was calculated for each period: baseline to end of TP 1 (day 6); end of TP 1 to end of TP 2 (day 12); end of TP 2 to end of TP 3 (day 18). ]
    The pediatric Functional Assessment of Chronic Illness Therapy-Fatigue (pedsFACIT-F) is an 11-item instrument derived from a comprehensive pediatric item bank that assesses fatigue. (Lai et al. Pediatr Hematol Oncol 2007) Measuring fatigue over the past 7 days in a population of pediatric cancer patients, the pedsFACIT-F instrument has a score ranging from 0-44, with a higher score meaning more fatigue. A minimally important difference (MID) was established as 4.7 points.



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Ages Eligible for Study:   7 Years to 21 Years   (Child, Adult)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01164956


Locations
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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
Boston Children’s Hospital
Investigators
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Principal Investigator: Christina Ullrich, MD, MPH Dana-Farber Cancer Institute/Children's Hospital Boston

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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
First Posted: July 19, 2010    Key Record Dates
Results First Posted: April 26, 2019
Last Update Posted: April 26, 2019
Last Verified: April 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Christina K. Ullrich, MD, MPH, Dana-Farber Cancer Institute:
methylphenidate
fatigue
Additional relevant MeSH terms:
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Methylphenidate
Fatigue
Signs and Symptoms
Central Nervous System Stimulants
Physiological Effects of Drugs
Dopamine Uptake Inhibitors
Neurotransmitter Uptake Inhibitors
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Dopamine Agents
Neurotransmitter Agents