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Trial record 28 of 439 for:    Methylphenidate

Trial of a Sustained Release Methylphenidate in the Treatment of Fatigue in Cancer Patients

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ClinicalTrials.gov Identifier: NCT00516269
Recruitment Status : Terminated (Slow Accrual)
First Posted : August 15, 2007
Results First Posted : April 26, 2013
Last Update Posted : January 3, 2018
Sponsor:
Collaborator:
Ortho-McNeil Janssen Scientific Affairs, LLC
Information provided by (Responsible Party):
M.D. Anderson Cancer Center

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Crossover Assignment;   Masking: Double (Participant, Investigator);   Primary Purpose: Treatment
Conditions Breast Cancer
Fatigue
Gastrointestinal Cancer
Interventions Drug: Methylphenidate
Drug: Placebo
Enrollment 42
Recruitment Details Recruitment Period: 03/11/2005 to 03/23/2011. All participants were recruited at UT MD Anderson Cancer Center.
Pre-assignment Details Participants were randomized to receive methylphenidate-placebo or placebo-methylphenidate. Of the 42 enrolled: 33 completed the study + 4 completed partial visits + 1 randomized to placebo twice (38 total), excluded were three who did not meet criteria (not randomized), and one who withdrew consent.
Arm/Group Title Methylphenidate Then Placebo Placebo Then Methylphenidate
Hide Arm/Group Description Methylphenidate 18 mg oral daily for 2 weeks then Placebo oral daily for 2 weeks Placebo oral daily for 2 weeks then Methylphenidate 18 mg oral daily for 2 weeks
Period Title: Overall Study
Started 19 19
Completed 17 [1] 16 [2]
Not Completed 2 3
Reason Not Completed
Adverse Event             2             1
Lost to Follow-up             0             1
Protocol Violation             0             1
[1]
2 patients had an early termination
[2]
2 patients did not complete the study and 1 randomized to placebo twice.
Arm/Group Title Methylphenidate Then Placebo Placebo Then Methylphenidate Total
Hide Arm/Group Description

18 mg Oral Daily for 2 Weeks

Placebo : Capsule By Mouth Daily x 2 Weeks

Methylphenidate : 18 mg By Mouth Daily x 2 Weeks

Placebo : Capsule By Mouth Daily x 2 Weeks

Methylphenidate : 18 mg By Mouth Daily x 2 Weeks

Total of all reporting groups
Overall Number of Baseline Participants 19 19 38
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 19 participants 19 participants 38 participants
<=18 years
0
   0.0%
0
   0.0%
0
   0.0%
Between 18 and 65 years
17
  89.5%
19
 100.0%
36
  94.7%
>=65 years
2
  10.5%
0
   0.0%
2
   5.3%
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 19 participants 19 participants 38 participants
53.26  (11.95) 51.52  (7.83) 52.35  (9.88)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 19 participants 19 participants 38 participants
Female
19
 100.0%
19
 100.0%
38
 100.0%
Male
0
   0.0%
0
   0.0%
0
   0.0%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 19 participants 19 participants 38 participants
19 19 38
1.Primary Outcome
Title Mean Difference Between Post-Methylphenidate and Post-Placebo Measurement
Hide Description The primary endpoint is the “fatigue worst” score (range: 0 – 10) on the Brief Fatigue Inventory (BFI) at the end of two-week treatment (either Methylphenidate or placebo). "Worst fatigue" is defined as participants' rating of worst fatigue on a scale of 0 (no fatigue) to 10 (as bad as can imagine). Since each participant is expected to receive both 2-week of Methylphenidate or 2-week placebo at different times, they serve as their own control. The outcome is the difference in “fatigue worst” score between post-Methylphenidate measurement and post-Placebo measurement.
Time Frame At end of two 2-week treatment cycles (4 weeks total)
Hide Outcome Measure Data
Hide Analysis Population Description
It is a crossover design and only the 33 patients who completed the study were included in the final data analysis.
Arm/Group Title Methylphenidate Placebo
Hide Arm/Group Description:
Methylphenidate 18 mg oral daily for 2 Weeks preceded or followed by Placebo oral daily for 2 weeks.
Placebo taken oral daily for 2 Weeks.
Overall Number of Participants Analyzed 33 33
Mean (Standard Deviation)
Unit of Measure: units on a scale
5.18  (2.52) 4.76  (2.68)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Methylphenidate, Placebo
Comments As a crossover study, the potential carryover effect was examined first. The pooled data (the 2-week treatment for each intervention i.e. period 1 & period 2) was used to assess the treatment effect (A versus B).
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.54
Comments [Not Specified]
Method Wilcoxon signed rank test
Comments [Not Specified]
Method of Estimation Estimation Parameter mean difference in treat versus control
Estimated Value 0.42
Parameter Dispersion
Type: Standard Deviation
Value: 3.3
Estimation Comments [Not Specified]
Time Frame Adverse events were collected for entire study period of 4 weeks.
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Methylphenidate Then Placebo Placebo Then Methylphenidate
Hide Arm/Group Description

18 mg Oral Daily for 2 Weeks

Placebo : Capsule By Mouth Daily x 2 Weeks

Methylphenidate : 18 mg By Mouth Daily x 2 Weeks

Placebo : Capsule By Mouth Daily x 2 Weeks

Methylphenidate : 18 mg By Mouth Daily x 2 Weeks

All-Cause Mortality
Methylphenidate Then Placebo Placebo Then Methylphenidate
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Methylphenidate Then Placebo Placebo Then Methylphenidate
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/19 (0.00%)      1/19 (5.26%)    
Blood and lymphatic system disorders     
Anemia  1 [1]  0/19 (0.00%)  0 1/19 (5.26%)  1
Infections and infestations     
Neutropenic fever  1 [2]  0/19 (0.00%)  0 1/19 (5.26%)  1
Indicates events were collected by systematic assessment
1
Term from vocabulary, CTCAE (3.0)
[1]
The patient was hospitalized for neutropenic fever and was found to have grade 3 anemia. Anemia was not related to the study drug. The SAE is related to chemotherapy administration.
[2]
One patient was hospitalized for treatment of neutropenic fever. The patient was on the treatment arm. The serious adverse event (SAE) was not related to study drug. The SAE was related to chemotherapy administration for underlying breast cancer.
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Methylphenidate Then Placebo Placebo Then Methylphenidate
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   7/19 (36.84%)      5/19 (26.32%)    
Blood and lymphatic system disorders     
Nose bleed  1  0/19 (0.00%)  0 1/19 (5.26%)  1
Cardiac disorders     
Palpitations  1  1/19 (5.26%)  1 0/19 (0.00%)  0
Sinus tachycardia  1  0/19 (0.00%)  0 1/19 (5.26%)  1
Gastrointestinal disorders     
Dry mouth  1  0/19 (0.00%)  0 1/19 (5.26%)  1
Abdominal discomfort  1  1/19 (5.26%)  1 1/19 (5.26%)  1
Vomiting  1  0/19 (0.00%)  0 1/19 (5.26%)  1
Diarrhea  1  0/19 (0.00%)  0 1/19 (5.26%)  1
Nausea  1  1/19 (5.26%)  1 0/19 (0.00%)  0
Musculoskeletal and connective tissue disorders     
Generalized weakness  1  0/19 (0.00%)  0 1/19 (5.26%)  1
Nervous system disorders     
Anxiety  1  1/19 (5.26%)  1 0/19 (0.00%)  0
Insomnia  1  1/19 (5.26%)  1 0/19 (0.00%)  0
Headache  1  2/19 (10.53%)  2 1/19 (5.26%)  1
Respiratory, thoracic and mediastinal disorders     
Sinus congestion  1  1/19 (5.26%)  1 1/19 (5.26%)  1
Cough  1  0/19 (0.00%)  0 1/19 (5.26%)  1
Upper respiratory infection  1  1/19 (5.26%)  1 2/19 (10.53%)  2
Allergic rhinitis  1  1/19 (5.26%)  1 0/19 (0.00%)  0
Skin and subcutaneous tissue disorders     
Rash/desquamation  1  0/19 (0.00%)  0 1/19 (5.26%)  1
Indicates events were collected by systematic assessment
1
Term from vocabulary, CTCAE (3.0)
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Carmen Escalante, MD / Professor
Organization: UT MD Anderson Cancer Center
EMail: RABaker@mdanderson.org
Layout table for additonal information
Responsible Party: M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier: NCT00516269     History of Changes
Other Study ID Numbers: ID00-372
First Submitted: August 14, 2007
First Posted: August 15, 2007
Results First Submitted: September 18, 2012
Results First Posted: April 26, 2013
Last Update Posted: January 3, 2018