Trial Outcomes & Findings for Trial of a Sustained Release Methylphenidate in the Treatment of Fatigue in Cancer Patients (NCT NCT00516269)

Last Updated: 2018-01-03

Results Overview

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.

Recruitment status

TERMINATED

Study phase

PHASE3

Target enrollment

42 participants

Primary outcome timeframe

At end of two 2-week treatment cycles (4 weeks total)

Results posted on

2018-01-03

Participant Flow

Recruitment Period: 03/11/2005 to 03/23/2011. All participants were recruited at UT MD Anderson Cancer Center.

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.

Participant milestones

Participant milestones
Measure	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
Overall Study STARTED	19	19
Overall Study COMPLETED	17	16
Overall Study NOT COMPLETED	2	3

Reasons for withdrawal

Reasons for withdrawal
Measure	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
Overall Study Adverse Event	2	1
Overall Study Lost to Follow-up	0	1
Overall Study Protocol Violation	0	1

Baseline Characteristics

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

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Methylphenidate Then Placebo n=19 Participants 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 n=19 Participants Placebo : Capsule By Mouth Daily x 2 Weeks Methylphenidate : 18 mg By Mouth Daily x 2 Weeks	Total n=38 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	17 Participants n=5 Participants	19 Participants n=7 Participants	36 Participants n=5 Participants
Age, Categorical >=65 years	2 Participants n=5 Participants	0 Participants n=7 Participants	2 Participants n=5 Participants
Age, Continuous	53.26 years STANDARD_DEVIATION 11.95 • n=5 Participants	51.52 years STANDARD_DEVIATION 7.83 • n=7 Participants	52.35 years STANDARD_DEVIATION 9.88 • n=5 Participants
Sex: Female, Male Female	19 Participants n=5 Participants	19 Participants n=7 Participants	38 Participants n=5 Participants
Sex: Female, Male Male	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Region of Enrollment United States	19 participants n=5 Participants	19 participants n=7 Participants	38 participants n=5 Participants

PRIMARY outcome

Timeframe: At end of two 2-week treatment cycles (4 weeks total)

Population: It is a crossover design and only the 33 patients who completed the study were included in the final data analysis.

Outcome measures

Outcome measures
Measure	Methylphenidate n=33 Participants Methylphenidate 18 mg oral daily for 2 Weeks preceded or followed by Placebo oral daily for 2 weeks.	Placebo n=33 Participants Placebo taken oral daily for 2 Weeks.
Mean Difference Between Post-Methylphenidate and Post-Placebo Measurement	5.18 units on a scale Standard Deviation 2.52	4.76 units on a scale Standard Deviation 2.68

Adverse Events

Methylphenidate Then Placebo

Serious events: 0 serious events

Other events: 7 other events

Deaths: 0 deaths

Placebo Then Methylphenidate

Serious events: 1 serious events

Other events: 5 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Methylphenidate Then Placebo n=19 participants at risk 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 n=19 participants at risk Placebo : Capsule By Mouth Daily x 2 Weeks Methylphenidate : 18 mg By Mouth Daily x 2 Weeks
Blood and lymphatic system disorders Anemia	0.00% 0/19 • Adverse events were collected for entire study period of 4 weeks.	5.3% 1/19 • Number of events 1 • Adverse events were collected for entire study period of 4 weeks.
Infections and infestations Neutropenic fever	0.00% 0/19 • Adverse events were collected for entire study period of 4 weeks.	5.3% 1/19 • Number of events 1 • Adverse events were collected for entire study period of 4 weeks.

Other adverse events

Additional Information

Carmen Escalante, MD / Professor

UT MD Anderson Cancer Center

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Measure	Methylphenidate Then Placebo n=19 participants at risk 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 n=19 participants at risk Placebo : Capsule By Mouth Daily x 2 Weeks Methylphenidate : 18 mg By Mouth Daily x 2 Weeks
Respiratory, thoracic and mediastinal disorders Sinus congestion	5.3% 1/19 • Number of events 1 • Adverse events were collected for entire study period of 4 weeks.	5.3% 1/19 • Number of events 1 • Adverse events were collected for entire study period of 4 weeks.
Respiratory, thoracic and mediastinal disorders Cough	0.00% 0/19 • Adverse events were collected for entire study period of 4 weeks.	5.3% 1/19 • Number of events 1 • Adverse events were collected for entire study period of 4 weeks.
Respiratory, thoracic and mediastinal disorders Upper respiratory infection	5.3% 1/19 • Number of events 1 • Adverse events were collected for entire study period of 4 weeks.	10.5% 2/19 • Number of events 2 • Adverse events were collected for entire study period of 4 weeks.
Respiratory, thoracic and mediastinal disorders Allergic rhinitis	5.3% 1/19 • Number of events 1 • Adverse events were collected for entire study period of 4 weeks.	0.00% 0/19 • Adverse events were collected for entire study period of 4 weeks.
Gastrointestinal disorders Dry mouth	0.00% 0/19 • Adverse events were collected for entire study period of 4 weeks.	5.3% 1/19 • Number of events 1 • Adverse events were collected for entire study period of 4 weeks.
Blood and lymphatic system disorders Nose bleed	0.00% 0/19 • Adverse events were collected for entire study period of 4 weeks.	5.3% 1/19 • Number of events 1 • Adverse events were collected for entire study period of 4 weeks.
Nervous system disorders Anxiety	5.3% 1/19 • Number of events 1 • Adverse events were collected for entire study period of 4 weeks.	0.00% 0/19 • Adverse events were collected for entire study period of 4 weeks.
Nervous system disorders Insomnia	5.3% 1/19 • Number of events 1 • Adverse events were collected for entire study period of 4 weeks.	0.00% 0/19 • Adverse events were collected for entire study period of 4 weeks.
Nervous system disorders Headache	10.5% 2/19 • Number of events 2 • Adverse events were collected for entire study period of 4 weeks.	5.3% 1/19 • Number of events 1 • Adverse events were collected for entire study period of 4 weeks.
Cardiac disorders Palpitations	5.3% 1/19 • Number of events 1 • Adverse events were collected for entire study period of 4 weeks.	0.00% 0/19 • Adverse events were collected for entire study period of 4 weeks.
Cardiac disorders Sinus tachycardia	0.00% 0/19 • Adverse events were collected for entire study period of 4 weeks.	5.3% 1/19 • Number of events 1 • Adverse events were collected for entire study period of 4 weeks.
Gastrointestinal disorders Abdominal discomfort	5.3% 1/19 • Number of events 1 • Adverse events were collected for entire study period of 4 weeks.	5.3% 1/19 • Number of events 1 • Adverse events were collected for entire study period of 4 weeks.
Gastrointestinal disorders Vomiting	0.00% 0/19 • Adverse events were collected for entire study period of 4 weeks.	5.3% 1/19 • Number of events 1 • Adverse events were collected for entire study period of 4 weeks.
Gastrointestinal disorders Diarrhea	0.00% 0/19 • Adverse events were collected for entire study period of 4 weeks.	5.3% 1/19 • Number of events 1 • Adverse events were collected for entire study period of 4 weeks.
Gastrointestinal disorders Nausea	5.3% 1/19 • Number of events 1 • Adverse events were collected for entire study period of 4 weeks.	0.00% 0/19 • Adverse events were collected for entire study period of 4 weeks.
Skin and subcutaneous tissue disorders Rash/desquamation	0.00% 0/19 • Adverse events were collected for entire study period of 4 weeks.	5.3% 1/19 • Number of events 1 • Adverse events were collected for entire study period of 4 weeks.
Musculoskeletal and connective tissue disorders Generalized weakness	0.00% 0/19 • Adverse events were collected for entire study period of 4 weeks.	5.3% 1/19 • Number of events 1 • Adverse events were collected for entire study period of 4 weeks.