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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

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor);   Primary Purpose: Supportive Care
Condition Cancer
Interventions Drug: methylphenidate
Other: Placebo
Enrollment 3
Recruitment Details 3 participants were enrolled between July 2011 and January 2012. Only the arms of these participants are presented.
Pre-assignment Details  
Arm/Group Title M-P, P-M, M-P P-M, P-M, M-P P-M, M-P, M-P
Hide Arm/Group Description 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. 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. 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.
Period Title: Overall Study
Started 1 1 1
Evaluable for pedsFACIT-F Score Change 0 1 0
Completed 0 1 0
Not Completed 1 0 1
Reason Not Completed
Side Effects             1             0             1
Arm/Group Title All Participants
Hide Arm/Group Description 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.
Overall Number of Baseline Participants 3
Hide Baseline Analysis Population Description
The analysis dataset is comprised of all enrolled patients.
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 3 participants
<=18 years
2
  66.7%
Between 18 and 65 years
1
  33.3%
>=65 years
0
   0.0%
Age, Continuous  
Mean (Full Range)
Unit of measure:  Years
Number Analyzed 3 participants
16
(11 to 20)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 3 participants
Female
1
  33.3%
Male
2
  66.7%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 3 participants
3
1.Primary Outcome
Title Completion Rate of Two Treatment Pairs Using the N-1-T Design
Hide Description 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.
Time Frame 18 days
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis dataset is comprised of all enrolled patients. Based on the definition of the outcome being evaluated, aggregation of data for all participants is appropriate.
Arm/Group Title All Participants
Hide Arm/Group Description:
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.
Overall Number of Participants Analyzed 3
Measure Type: Number
Unit of Measure: participants
1
2.Secondary Outcome
Title Rate of Receiving Clinically Definite Answer Regarding the Ability of Experimental Treatment to Reduce Fatigue Using the N-1-T Design
Hide Description 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.
Time Frame 18 days
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis dataset is comprised of all enrolled patients.
Arm/Group Title M-P, P-M, M-P P-M, P-M, M-P P-M, M-P, M-P
Hide Arm/Group Description:
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.
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.
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.
Overall Number of Participants Analyzed 1 1 1
Measure Type: Number
Unit of Measure: participants
0 1 0
3.Secondary Outcome
Title Change Over Treatment Pairs in pedsFACIT-F Score
Hide Description 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.
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).
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis dataset is comprised of all enrolled patients with data at baseline and end of all treatment pairs.
Arm/Group Title P-M, P-M, M-P
Hide Arm/Group Description:
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.
Overall Number of Participants Analyzed 1
Measure Type: Number
Unit of Measure: units on a scale
Change from Baseline to end of Treatment Pair 1 4
Change from end of Treatment Pair 1 to Pair 2 2
Change from end of Treatment Pair 2 to Pair 3 0
Time Frame Adverse event data was collected continuously during treatment. As noted in limitations, the study did not meet the accrual target due to lack of resources. AE data by individual is not accessible and therefore AE outcomes for the 3 participants are aggregated.
Adverse Event Reporting Description The metabolic/laboratory-other cases were elevated lactate dehydrogenase (LDH), ketonuria and bilirubin in urinalysis. The cardiac-other case was hypertensionsinus tachycardia. The constitutional symptoms-other case was decreased appetite.
 
Arm/Group Title All Participants
Hide Arm/Group Description 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.
All-Cause Mortality
All Participants
Affected / at Risk (%)
Total   0/3 (0.00%) 
Show Serious Adverse Events Hide Serious Adverse Events
All Participants
Affected / at Risk (%)
Total   0/3 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
All Participants
Affected / at Risk (%)
Total   3/3 (100.00%) 
Blood and lymphatic system disorders   
hemoglobin  1  1/3 (33.33%) 
Cardiac disorders   
Cardiac General-Other  1  1/3 (33.33%) 
Ear and labyrinth disorders   
Tinnitus  1  1/3 (33.33%) 
Gastrointestinal disorders   
diarrhea  1  2/3 (66.67%) 
General disorders   
Rigors/chills  1  1/3 (33.33%) 
Constitutional Symptoms-Other  1  1/3 (33.33%) 
fatigue  1  2/3 (66.67%) 
Fever (in the absence of neutropenia, where neutropenia is defined as ANC <1.0 x 10e9/L)  1  1/3 (33.33%) 
Infections and infestations   
Infection-Other  1  1/3 (33.33%) 
Injury, poisoning and procedural complications   
fracture  1  1/3 (33.33%) 
Investigations   
Metabolic/Laboratory-Other  1  1/3 (33.33%) 
Creatinine  1  1/3 (33.33%) 
Alkaline phosphatase  1  2/3 (66.67%) 
ALT, SGPT (serum glutamic pyruvic transaminase)  1  2/3 (66.67%) 
AST, SGOT (serum glutamic oxaloacetic transaminase)  1  2/3 (66.67%) 
PTT (Partial thromboplastin time)  1  1/3 (33.33%) 
Metabolism and nutrition disorders   
Dehydration  1  1/3 (33.33%) 
Albumin, serum-low (hypoalbuminemia)  1  1/3 (33.33%) 
Calcium, serum-low (hypocalcemia)  1  1/3 (33.33%) 
Potassium, serum-low (hypokalemia)  1  1/3 (33.33%) 
Magnesium, serum-low (hypomagnesemia)  1  1/3 (33.33%) 
Sodium, serum-low (hyponatremia)  1  2/3 (66.67%) 
Phosphate, serum-low (hypophosphatemia)  1  2/3 (66.67%) 
Musculoskeletal and connective tissue disorders   
Pain - Muscle  1  1/3 (33.33%) 
Nervous system disorders   
Neuropathy: cranial - CN VII Motor-face; Sensory-taste  1  1/3 (33.33%) 
Tremor  1  1/3 (33.33%) 
Psychiatric disorders   
Mood alteration - anxiety  1  1/3 (33.33%) 
Insomnia  1  1/3 (33.33%) 
Renal and urinary disorders   
Proteinuria  1  1/3 (33.33%) 
Urine color change  1  1/3 (33.33%) 
Vascular disorders   
hypotension  1  1/3 (33.33%) 
1
Term from vocabulary, CTCAE (3.0)
Indicates events were collected by systematic assessment
The study was terminated early due to insufficient resources.
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Christina K. Ullrich, MD, MPH
Organization: Dana-Farber Cancer Institute
Phone: 617.632.4997
EMail: Christina_Ullrich@dfci.harvard.edu
Layout table for additonal information
Responsible Party: Christina K. Ullrich, MD, MPH, Dana-Farber Cancer Institute
ClinicalTrials.gov Identifier: NCT01164956     History of Changes
Other Study ID Numbers: 10-146
First Submitted: July 6, 2010
First Posted: July 19, 2010
Results First Submitted: April 17, 2017
Results First Posted: April 26, 2019
Last Update Posted: April 26, 2019