Methylphenidate for Cancer-Related Fatigue

Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01164956
• Other study ID #: 10-146
• Status: Terminated
• Phase: Phase 1
• Start date: July 2011
• Est. completion date: March 2013

Study information

• Verified date: April 2019
• Source: Dana-Farber Cancer Institute
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 3
• Est. completion date: March 2013
• Est. primary completion date: March 2013
• Accepts healthy volunteers: No
• Gender: All
• Age group: 7 Years to 21 Years

Eligibility

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

Related Conditions & MeSH terms

• Cancer
• Fatigue

Intervention

Drug:
• methylphenidate

Other:
• Placebo

Locations

Country	Name	City	State
United States	Boston Children's Hospital	Boston	Massachusetts
United States	Dana-Farber Cancer Institute	Boston	Massachusetts

Sponsors (2)

Lead Sponsor	Collaborator
Dana-Farber Cancer Institute	Boston Children’s Hospital

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Completion Rate of Two Treatment Pairs Using the N-1-T Design	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.	18 days
Secondary	Rate of Receiving Clinically Definite Answer Regarding the Ability of Experimental Treatment to Reduce Fatigue Using the N-1-T Design	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.	18 days
Secondary	Change Over Treatment Pairs in pedsFACIT-F Score	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.	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).