Ignite Creation Date:
2025-12-24 @ 11:33 PM
Ignite Modification Date:
2025-12-25 @ 9:22 PM
Study NCT ID:
NCT01164956
Status:
TERMINATED
Last Update Posted:
2019-04-26
First Post:
2010-07-06
Is NOT Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
Methylphenidate for Cancer-Related Fatigue
Sponsor:
Dana-Farber Cancer Institute
Organization:
Study Overview
Official Title:
Methylphenidate for Cancer-Related Fatigue: A Pilot N-of-1 Study
Status:
TERMINATED
Status Verified Date:
2019-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Insufficient Resources
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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.
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
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
Study Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: