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Methylphenidate Study in Breast or Gastrointestinal Cancer Patients

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
Ortho-McNeil Janssen Scientific Affairs, LLC
Information provided by (Responsible Party):
M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier:
NCT00516269
First received: August 14, 2007
Last updated: April 24, 2013
Last verified: April 2013
History of Changes
Results First Received: September 18, 2012  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Crossover Assignment;   Masking: Double Blind (Subject, Investigator);   Primary Purpose: Treatment
Conditions: Breast Cancer
Fatigue
Gastrointestinal Cancer
Interventions: Drug: Methylphenidate
Drug: Placebo

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
Recruitment Period: 03/11/2005 to 03/23/2011. All participants were recruited at UT MD Anderson Cancer Center.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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.

Reporting Groups
  Description
Methylphenidate Then Placebo Methylphenidate 18 mg oral daily for 2 weeks then Placebo oral daily for 2 weeks
Placebo Then Methylphenidate Placebo oral daily for 2 weeks then Methylphenidate 18 mg oral daily for 2 weeks

Participant Flow:   Overall Study
    Methylphenidate Then Placebo     Placebo Then Methylphenidate  
STARTED     19     19  
COMPLETED     17 [1]   16 [2]
NOT COMPLETED     2     3  
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.



  Baseline Characteristics
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Reporting Groups
  Description
Methylphenidate Then Placebo

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 Then Methylphenidate

Placebo : Capsule By Mouth Daily x 2 Weeks

Methylphenidate : 18 mg By Mouth Daily x 2 Weeks
Total Total of all reporting groups

Baseline Measures
    Methylphenidate Then Placebo     Placebo Then Methylphenidate     Total  
Number of Participants  
[units: participants]
 		  19     19     38  
Age  
[units: participants]
 		     
<=18 years     0     0     0  
Between 18 and 65 years     17     19     36  
>=65 years     2     0     2  
Age  
[units: years]
Mean ± Standard Deviation 		  53.26  ± 11.95     51.52  ± 7.83     52.35  ± 9.88  
Gender  
[units: participants]
 		     
Female     19     19     38  
Male     0     0     0  
Region of Enrollment  
[units: participants]
 		     
United States     19     19     38  



  Outcome Measures

1.  Primary:   Mean Difference Between Post-Methylphenidate and Post-Placebo Measurement   [ Time Frame: At end of two 2-week treatment cycles (4 weeks total) ]
  Show Outcome Measure 1


  Serious Adverse Events
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  Other Adverse Events
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  More Information
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Certain Agreements:  
All Principal Investigators ARE employed by the organization sponsoring the study.


Limitations and Caveats
Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
Early termination due to slow accrual.  


Results Point of Contact:  
Name/Title: Carmen Escalante, MD / Professor
Organization: UT MD Anderson Cancer Center
e-mail: RABaker@mdanderson.org


No publications provided


Responsible Party: M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier: NCT00516269     History of Changes
Other Study ID Numbers: ID00-372
Study First Received: August 14, 2007
Results First Received: September 18, 2012
Last Updated: April 24, 2013
Health Authority: United States: Institutional Review Board