Description Module
The Description Module contains narrative descriptions of the clinical trial, including a brief summary and detailed description. These descriptions provide important information about the study's purpose, methodology, and key details in language accessible to both researchers and the general public.
Description Module path is as follows:
Study -> Protocol Section -> Description Module
Description Module
Ignite Creation Date:
2025-12-24 @ 11:33 PM
Ignite Modification Date:
2025-12-24 @ 11:33 PM
NCT ID:
NCT01164956
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
Study:
NCT01164956
Study Brief:
Protocol Section:
NCT01164956