Trial Outcomes & Findings for Methylphenidate and a Nursing Telephone Intervention for Fatigue (NCT NCT00424099)

Last Updated: 2023-06-01

Results Overview

FACIT-F fatigue subscale consists of 13 items. Patients rate the intensity of their fatigue symptoms on a scale of 0 to 4 (0=not at all and 4=very much). Total FACIT-F fatigue subscale score ranges from 0 to 52 with higher scores indicate higher fatigue. We measured the median change in FACIT-F fatigue sub scale score between Baseline and Day 15 using Kruskal-Wallis test.

Recruitment status

COMPLETED

Study phase

PHASE2/PHASE3

Target enrollment

197 participants

Primary outcome timeframe

Baseline and Day 15

Results posted on

2023-06-01

Participant Flow

Patients were recruited from outpatient palliative care and oncology clinics at MD Anderson Cancer Center or from outpatient clinics at Lyndon B. Johnson General Hospital in Houston, Texas.

A total of 197 participants were enrolled in the study but 190 were randomized. 7 participants were not randomized for various reasons.

Participant milestones

Participant milestones
Measure	Methylphenidate (MP) + Nursing Telephone Intervention (NTI) One 5-mg Methylphenidate capsule was administered orally every 2 hours as needed up to 20 mg per day for 14 days and NTI phone calls four to six times over the 2 weeks	Methylphenidate (MP) + Control Telephone Intervention (CTI) One 5-mg Methylphenidate capsule was administered orally every 2 hours as needed up to 20 mg per day for 14 days and CTI phone calls four to six times over the 2 weeks	Placebo (PL)+ Nursing Telephone Intervention (NTI) One Placebo capsule was administered orally every 2 hours as needed up to four capsules per day for 14 days and NTI phone calls four to six times over the 2 weeks	Placebo (PL) + Control Telephone Intervention (CTI) One Placebo capsule was administered orally every 2 hours as needed up to four capsules per day for 14 days and CTI phone calls four to six times over the 2 weeks
Overall Study STARTED	45	47	50	48
Overall Study COMPLETED	38	31	38	35
Overall Study NOT COMPLETED	7	16	12	13

Reasons for withdrawal

Reasons for withdrawal
Measure	Methylphenidate (MP) + Nursing Telephone Intervention (NTI) One 5-mg Methylphenidate capsule was administered orally every 2 hours as needed up to 20 mg per day for 14 days and NTI phone calls four to six times over the 2 weeks	Methylphenidate (MP) + Control Telephone Intervention (CTI) One 5-mg Methylphenidate capsule was administered orally every 2 hours as needed up to 20 mg per day for 14 days and CTI phone calls four to six times over the 2 weeks	Placebo (PL)+ Nursing Telephone Intervention (NTI) One Placebo capsule was administered orally every 2 hours as needed up to four capsules per day for 14 days and NTI phone calls four to six times over the 2 weeks	Placebo (PL) + Control Telephone Intervention (CTI) One Placebo capsule was administered orally every 2 hours as needed up to four capsules per day for 14 days and CTI phone calls four to six times over the 2 weeks
Overall Study Adverse Event	0	1	1	0
Overall Study Death	0	1	0	0
Overall Study Illness	2	0	1	4
Overall Study Lost to Follow-up	0	0	3	0
Overall Study Hospitalized	1	2	1	3
Overall Study UNABLE OR Unavailable to complete questionnaires	3	3	0	0
Overall Study Withdrawal by Subject	1	9	4	6
Overall Study Physician Decision	0	0	1	0
Overall Study Missing	0	0	1	0

Baseline Characteristics

Methylphenidate and a Nursing Telephone Intervention for Fatigue

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Methylphenidate (MP) + Nursing Telephone Intervention (NTI) n=45 Participants One 5-mg Methylphenidate capsule was administered orally every 2 hours as needed up to 20 mg per day for 14 days and NTI phone calls four to six times over the 2 weeks	Methylphenidate (MP) + Control Telephone Intervention (CTI) n=47 Participants One 5-mg Methylphenidate capsule was administered orally every 2 hours as needed up to 20 mg per day for 14 days and CTI phone calls four to six times over the 2 weeks	Placebo (PL)+ Nursing Telephone Intervention (NTI) n=50 Participants One Placebo capsule was administered orally every 2 hours as needed up to four capsules per day for 14 days and NTI phone calls four to six times over the 2 weeks	Placebo (PL) + Control Telephone Intervention (CTI) n=48 Participants One Placebo capsule was administered orally every 2 hours as needed up to four capsules per day for 14 days and CTI phone calls four to six times over the 2 weeks	Total n=190 Participants Total of all reporting groups
Age, Continuous	58 years n=5 Participants	56 years n=7 Participants	59 years n=5 Participants	58 years n=4 Participants	57.5 years n=21 Participants
Sex: Female, Male Female	29 Participants n=5 Participants	34 Participants n=7 Participants	33 Participants n=5 Participants	32 Participants n=4 Participants	128 Participants n=21 Participants
Sex: Female, Male Male	16 Participants n=5 Participants	13 Participants n=7 Participants	17 Participants n=5 Participants	16 Participants n=4 Participants	62 Participants n=21 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	8 Participants n=5 Participants	6 Participants n=7 Participants	10 Participants n=5 Participants	8 Participants n=4 Participants	32 Participants n=21 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	37 Participants n=5 Participants	41 Participants n=7 Participants	40 Participants n=5 Participants	40 Participants n=4 Participants	158 Participants n=21 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants	2 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	2 Participants n=21 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants
Race (NIH/OMB) Black or African American	3 Participants n=5 Participants	5 Participants n=7 Participants	4 Participants n=5 Participants	7 Participants n=4 Participants	19 Participants n=21 Participants
Race (NIH/OMB) White	42 Participants n=5 Participants	40 Participants n=7 Participants	46 Participants n=5 Participants	41 Participants n=4 Participants	169 Participants n=21 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants
Region of Enrollment United States	45 participants n=5 Participants	47 participants n=7 Participants	50 participants n=5 Participants	48 participants n=4 Participants	190 participants n=21 Participants
Baseline Functional Assessment of Chronic Illness Therapy (FACIT-F ) Fatigue Subscale Score	21.50 score on a scale n=5 Participants	20.00 score on a scale n=7 Participants	20.00 score on a scale n=5 Participants	21.50 score on a scale n=4 Participants	20.00 score on a scale n=21 Participants
Baseline Edmonton Symptom Assessment System (ESAS) Fatigue Score	7.00 score on a scale n=5 Participants	6.00 score on a scale n=7 Participants	6.00 score on a scale n=5 Participants	6.00 score on a scale n=4 Participants	6.00 score on a scale n=21 Participants

PRIMARY outcome

Timeframe: Baseline and Day 15

Population: Those who completed intervention up to day 15

Outcome measures

Outcome measures
Measure	Methylphenidate (MP) + Nursing Telephone Intervention (NTI) n=37 Participants One 5-mg Methylphenidate capsule was administered orally every 2 hours as needed up to 20 mg per day for 14 days and NTI phone calls four to six times over the 2 weeks	Methylphenidate (MP) + Control Telephone Intervention (CTI) n=31 Participants One 5-mg Methylphenidate capsule was administered orally every 2 hours as needed up to 20 mg per day for 14 days and CTI phone calls four to six times over the 2 weeks	Placebo (PL)+ Nursing Telephone Intervention (NTI) n=38 Participants One Placebo capsule was administered orally every 2 hours as needed up to four capsules per day for 14 days and NTI phone calls four to six times over the 2 weeks	Placebo (PL) + Control Telephone Intervention (CTI) n=35 Participants One Placebo capsule was administered orally every 2 hours as needed up to four capsules per day for 14 days and CTI phone calls four to six times over the 2 weeks
Change in Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-F) Fatigue Subscale Score	4.00 score on a scale Interval -2.0 to 11.0	7.00 score on a scale Interval 2.0 to 11.0	8.50 score on a scale Interval 3.0 to 17.0	5.00 score on a scale Interval 0.0 to 6.0

SECONDARY outcome

Timeframe: Baseline and Day 15

The ESAS was used to assess the following 9 symptoms commonly experienced symptoms by cancer patients: pain, fatigue, nausea, depression, anxiety, drowsiness, dyspnea, anorexia, and well-being. Patients rate the intensity of their fatigue symptoms on a scale of 0 to 10 (0=not at all and 10=very much). Total ESAS fatigue score ranges from 0 to 10 with higher scores indicate higher fatigue. We measured the median change in ESAS fatigue score between Baseline and Day 15 using Kruskal-Wallis test.

Outcome measures

Outcome measures
Measure	Methylphenidate (MP) + Nursing Telephone Intervention (NTI) n=37 Participants One 5-mg Methylphenidate capsule was administered orally every 2 hours as needed up to 20 mg per day for 14 days and NTI phone calls four to six times over the 2 weeks	Methylphenidate (MP) + Control Telephone Intervention (CTI) n=29 Participants One 5-mg Methylphenidate capsule was administered orally every 2 hours as needed up to 20 mg per day for 14 days and CTI phone calls four to six times over the 2 weeks	Placebo (PL)+ Nursing Telephone Intervention (NTI) n=37 Participants One Placebo capsule was administered orally every 2 hours as needed up to four capsules per day for 14 days and NTI phone calls four to six times over the 2 weeks	Placebo (PL) + Control Telephone Intervention (CTI) n=34 Participants One Placebo capsule was administered orally every 2 hours as needed up to four capsules per day for 14 days and CTI phone calls four to six times over the 2 weeks
Change in Edmonton Symptom Assessment System (ESAS) Fatigue Score	-3.00 score on a scale Interval -4.0 to -1.0	-1.00 score on a scale Interval -3.0 to 0.0	-2.00 score on a scale Interval -5.0 to 0.0	-2.00 score on a scale Interval -4.0 to 0.0

Adverse Events

Methylphenidate (MP) +Nursing Telephone Intervention (NTI)

Serious events: 0 serious events

Other events: 9 other events

Deaths: 0 deaths

Methylphenidate (MP) +Control Telephone Intervention (CTI)

Serious events: 0 serious events

Other events: 4 other events

Deaths: 1 deaths

Placebo (PL)+ Nursing Telephone Intervention (NTI)

Serious events: 0 serious events

Other events: 4 other events

Deaths: 0 deaths

Placebo (PL) + Control Telephone Intervention (CTI)

Serious events: 0 serious events

Other events: 9 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	Methylphenidate (MP) +Nursing Telephone Intervention (NTI) n=45 participants at risk One 5-mg Methylphenidate capsule was administered orally every 2 hours as needed up to 20 mg per day for 14 days and NTI phone calls four to six times over the 2 weeks	Methylphenidate (MP) +Control Telephone Intervention (CTI) n=47 participants at risk One 5-mg Methylphenidate capsule was administered orally every 2 hours as needed up to 20 mg per day for 14 days and CTI phone calls four to six times over the 2 weeks	Placebo (PL)+ Nursing Telephone Intervention (NTI) n=50 participants at risk One Placebo capsule was administered orally every 2 hours as needed up to four capsules per day for 14 days and NTI phone calls four to six times over the 2 weeks	Placebo (PL) + Control Telephone Intervention (CTI) n=48 participants at risk One Placebo capsule was administered orally every 2 hours as needed up to four capsules per day for 14 days and CTI phone calls four to six times over the 2 weeks
Nervous system disorders Pain	4.4% 2/45 • Adverse events measured up to 15 days Adverse Events data were presented in 2 arms. The reason is that only the Intervention medicine Methylphenidate (MP) can produce Adverse Events, not the telephone calls. This is why the two Methylphenidate arms (MP+ NTI and MP+CTI) were combined into one arm and similarly the two Placebo arms were combined into one arm.	2.1% 1/47 • Adverse events measured up to 15 days Adverse Events data were presented in 2 arms. The reason is that only the Intervention medicine Methylphenidate (MP) can produce Adverse Events, not the telephone calls. This is why the two Methylphenidate arms (MP+ NTI and MP+CTI) were combined into one arm and similarly the two Placebo arms were combined into one arm.	4.0% 2/50 • Adverse events measured up to 15 days Adverse Events data were presented in 2 arms. The reason is that only the Intervention medicine Methylphenidate (MP) can produce Adverse Events, not the telephone calls. This is why the two Methylphenidate arms (MP+ NTI and MP+CTI) were combined into one arm and similarly the two Placebo arms were combined into one arm.	2.1% 1/48 • Adverse events measured up to 15 days Adverse Events data were presented in 2 arms. The reason is that only the Intervention medicine Methylphenidate (MP) can produce Adverse Events, not the telephone calls. This is why the two Methylphenidate arms (MP+ NTI and MP+CTI) were combined into one arm and similarly the two Placebo arms were combined into one arm.
Nervous system disorders Insomnia	6.7% 3/45 • Adverse events measured up to 15 days Adverse Events data were presented in 2 arms. The reason is that only the Intervention medicine Methylphenidate (MP) can produce Adverse Events, not the telephone calls. This is why the two Methylphenidate arms (MP+ NTI and MP+CTI) were combined into one arm and similarly the two Placebo arms were combined into one arm.	0.00% 0/47 • Adverse events measured up to 15 days Adverse Events data were presented in 2 arms. The reason is that only the Intervention medicine Methylphenidate (MP) can produce Adverse Events, not the telephone calls. This is why the two Methylphenidate arms (MP+ NTI and MP+CTI) were combined into one arm and similarly the two Placebo arms were combined into one arm.	2.0% 1/50 • Adverse events measured up to 15 days Adverse Events data were presented in 2 arms. The reason is that only the Intervention medicine Methylphenidate (MP) can produce Adverse Events, not the telephone calls. This is why the two Methylphenidate arms (MP+ NTI and MP+CTI) were combined into one arm and similarly the two Placebo arms were combined into one arm.	6.2% 3/48 • Adverse events measured up to 15 days Adverse Events data were presented in 2 arms. The reason is that only the Intervention medicine Methylphenidate (MP) can produce Adverse Events, not the telephone calls. This is why the two Methylphenidate arms (MP+ NTI and MP+CTI) were combined into one arm and similarly the two Placebo arms were combined into one arm.
Psychiatric disorders Mood Alteration	2.2% 1/45 • Adverse events measured up to 15 days Adverse Events data were presented in 2 arms. The reason is that only the Intervention medicine Methylphenidate (MP) can produce Adverse Events, not the telephone calls. This is why the two Methylphenidate arms (MP+ NTI and MP+CTI) were combined into one arm and similarly the two Placebo arms were combined into one arm.	2.1% 1/47 • Adverse events measured up to 15 days Adverse Events data were presented in 2 arms. The reason is that only the Intervention medicine Methylphenidate (MP) can produce Adverse Events, not the telephone calls. This is why the two Methylphenidate arms (MP+ NTI and MP+CTI) were combined into one arm and similarly the two Placebo arms were combined into one arm.	0.00% 0/50 • Adverse events measured up to 15 days Adverse Events data were presented in 2 arms. The reason is that only the Intervention medicine Methylphenidate (MP) can produce Adverse Events, not the telephone calls. This is why the two Methylphenidate arms (MP+ NTI and MP+CTI) were combined into one arm and similarly the two Placebo arms were combined into one arm.	2.1% 1/48 • Adverse events measured up to 15 days Adverse Events data were presented in 2 arms. The reason is that only the Intervention medicine Methylphenidate (MP) can produce Adverse Events, not the telephone calls. This is why the two Methylphenidate arms (MP+ NTI and MP+CTI) were combined into one arm and similarly the two Placebo arms were combined into one arm.
Gastrointestinal disorders Nausea	4.4% 2/45 • Adverse events measured up to 15 days Adverse Events data were presented in 2 arms. The reason is that only the Intervention medicine Methylphenidate (MP) can produce Adverse Events, not the telephone calls. This is why the two Methylphenidate arms (MP+ NTI and MP+CTI) were combined into one arm and similarly the two Placebo arms were combined into one arm.	0.00% 0/47 • Adverse events measured up to 15 days Adverse Events data were presented in 2 arms. The reason is that only the Intervention medicine Methylphenidate (MP) can produce Adverse Events, not the telephone calls. This is why the two Methylphenidate arms (MP+ NTI and MP+CTI) were combined into one arm and similarly the two Placebo arms were combined into one arm.	0.00% 0/50 • Adverse events measured up to 15 days Adverse Events data were presented in 2 arms. The reason is that only the Intervention medicine Methylphenidate (MP) can produce Adverse Events, not the telephone calls. This is why the two Methylphenidate arms (MP+ NTI and MP+CTI) were combined into one arm and similarly the two Placebo arms were combined into one arm.	2.1% 1/48 • Adverse events measured up to 15 days Adverse Events data were presented in 2 arms. The reason is that only the Intervention medicine Methylphenidate (MP) can produce Adverse Events, not the telephone calls. This is why the two Methylphenidate arms (MP+ NTI and MP+CTI) were combined into one arm and similarly the two Placebo arms were combined into one arm.
Cardiac disorders Hypertension	0.00% 0/45 • Adverse events measured up to 15 days Adverse Events data were presented in 2 arms. The reason is that only the Intervention medicine Methylphenidate (MP) can produce Adverse Events, not the telephone calls. This is why the two Methylphenidate arms (MP+ NTI and MP+CTI) were combined into one arm and similarly the two Placebo arms were combined into one arm.	2.1% 1/47 • Adverse events measured up to 15 days Adverse Events data were presented in 2 arms. The reason is that only the Intervention medicine Methylphenidate (MP) can produce Adverse Events, not the telephone calls. This is why the two Methylphenidate arms (MP+ NTI and MP+CTI) were combined into one arm and similarly the two Placebo arms were combined into one arm.	0.00% 0/50 • Adverse events measured up to 15 days Adverse Events data were presented in 2 arms. The reason is that only the Intervention medicine Methylphenidate (MP) can produce Adverse Events, not the telephone calls. This is why the two Methylphenidate arms (MP+ NTI and MP+CTI) were combined into one arm and similarly the two Placebo arms were combined into one arm.	2.1% 1/48 • Adverse events measured up to 15 days Adverse Events data were presented in 2 arms. The reason is that only the Intervention medicine Methylphenidate (MP) can produce Adverse Events, not the telephone calls. This is why the two Methylphenidate arms (MP+ NTI and MP+CTI) were combined into one arm and similarly the two Placebo arms were combined into one arm.
Gastrointestinal disorders Anorexia	2.2% 1/45 • Adverse events measured up to 15 days Adverse Events data were presented in 2 arms. The reason is that only the Intervention medicine Methylphenidate (MP) can produce Adverse Events, not the telephone calls. This is why the two Methylphenidate arms (MP+ NTI and MP+CTI) were combined into one arm and similarly the two Placebo arms were combined into one arm.	0.00% 0/47 • Adverse events measured up to 15 days Adverse Events data were presented in 2 arms. The reason is that only the Intervention medicine Methylphenidate (MP) can produce Adverse Events, not the telephone calls. This is why the two Methylphenidate arms (MP+ NTI and MP+CTI) were combined into one arm and similarly the two Placebo arms were combined into one arm.	0.00% 0/50 • Adverse events measured up to 15 days Adverse Events data were presented in 2 arms. The reason is that only the Intervention medicine Methylphenidate (MP) can produce Adverse Events, not the telephone calls. This is why the two Methylphenidate arms (MP+ NTI and MP+CTI) were combined into one arm and similarly the two Placebo arms were combined into one arm.	0.00% 0/48 • Adverse events measured up to 15 days Adverse Events data were presented in 2 arms. The reason is that only the Intervention medicine Methylphenidate (MP) can produce Adverse Events, not the telephone calls. This is why the two Methylphenidate arms (MP+ NTI and MP+CTI) were combined into one arm and similarly the two Placebo arms were combined into one arm.
Cardiac disorders Syncope	0.00% 0/45 • Adverse events measured up to 15 days Adverse Events data were presented in 2 arms. The reason is that only the Intervention medicine Methylphenidate (MP) can produce Adverse Events, not the telephone calls. This is why the two Methylphenidate arms (MP+ NTI and MP+CTI) were combined into one arm and similarly the two Placebo arms were combined into one arm.	0.00% 0/47 • Adverse events measured up to 15 days Adverse Events data were presented in 2 arms. The reason is that only the Intervention medicine Methylphenidate (MP) can produce Adverse Events, not the telephone calls. This is why the two Methylphenidate arms (MP+ NTI and MP+CTI) were combined into one arm and similarly the two Placebo arms were combined into one arm.	2.0% 1/50 • Adverse events measured up to 15 days Adverse Events data were presented in 2 arms. The reason is that only the Intervention medicine Methylphenidate (MP) can produce Adverse Events, not the telephone calls. This is why the two Methylphenidate arms (MP+ NTI and MP+CTI) were combined into one arm and similarly the two Placebo arms were combined into one arm.	0.00% 0/48 • Adverse events measured up to 15 days Adverse Events data were presented in 2 arms. The reason is that only the Intervention medicine Methylphenidate (MP) can produce Adverse Events, not the telephone calls. This is why the two Methylphenidate arms (MP+ NTI and MP+CTI) were combined into one arm and similarly the two Placebo arms were combined into one arm.
Respiratory, thoracic and mediastinal disorders Flu-like symptom	0.00% 0/45 • Adverse events measured up to 15 days Adverse Events data were presented in 2 arms. The reason is that only the Intervention medicine Methylphenidate (MP) can produce Adverse Events, not the telephone calls. This is why the two Methylphenidate arms (MP+ NTI and MP+CTI) were combined into one arm and similarly the two Placebo arms were combined into one arm.	0.00% 0/47 • Adverse events measured up to 15 days Adverse Events data were presented in 2 arms. The reason is that only the Intervention medicine Methylphenidate (MP) can produce Adverse Events, not the telephone calls. This is why the two Methylphenidate arms (MP+ NTI and MP+CTI) were combined into one arm and similarly the two Placebo arms were combined into one arm.	0.00% 0/50 • Adverse events measured up to 15 days Adverse Events data were presented in 2 arms. The reason is that only the Intervention medicine Methylphenidate (MP) can produce Adverse Events, not the telephone calls. This is why the two Methylphenidate arms (MP+ NTI and MP+CTI) were combined into one arm and similarly the two Placebo arms were combined into one arm.	2.1% 1/48 • Adverse events measured up to 15 days Adverse Events data were presented in 2 arms. The reason is that only the Intervention medicine Methylphenidate (MP) can produce Adverse Events, not the telephone calls. This is why the two Methylphenidate arms (MP+ NTI and MP+CTI) were combined into one arm and similarly the two Placebo arms were combined into one arm.
Cardiac disorders Tachycardia	0.00% 0/45 • Adverse events measured up to 15 days Adverse Events data were presented in 2 arms. The reason is that only the Intervention medicine Methylphenidate (MP) can produce Adverse Events, not the telephone calls. This is why the two Methylphenidate arms (MP+ NTI and MP+CTI) were combined into one arm and similarly the two Placebo arms were combined into one arm.	0.00% 0/47 • Adverse events measured up to 15 days Adverse Events data were presented in 2 arms. The reason is that only the Intervention medicine Methylphenidate (MP) can produce Adverse Events, not the telephone calls. This is why the two Methylphenidate arms (MP+ NTI and MP+CTI) were combined into one arm and similarly the two Placebo arms were combined into one arm.	0.00% 0/50 • Adverse events measured up to 15 days Adverse Events data were presented in 2 arms. The reason is that only the Intervention medicine Methylphenidate (MP) can produce Adverse Events, not the telephone calls. This is why the two Methylphenidate arms (MP+ NTI and MP+CTI) were combined into one arm and similarly the two Placebo arms were combined into one arm.	2.1% 1/48 • Adverse events measured up to 15 days Adverse Events data were presented in 2 arms. The reason is that only the Intervention medicine Methylphenidate (MP) can produce Adverse Events, not the telephone calls. This is why the two Methylphenidate arms (MP+ NTI and MP+CTI) were combined into one arm and similarly the two Placebo arms were combined into one arm.
Musculoskeletal and connective tissue disorders Slurred Speech	0.00% 0/45 • Adverse events measured up to 15 days Adverse Events data were presented in 2 arms. The reason is that only the Intervention medicine Methylphenidate (MP) can produce Adverse Events, not the telephone calls. This is why the two Methylphenidate arms (MP+ NTI and MP+CTI) were combined into one arm and similarly the two Placebo arms were combined into one arm.	2.1% 1/47 • Adverse events measured up to 15 days Adverse Events data were presented in 2 arms. The reason is that only the Intervention medicine Methylphenidate (MP) can produce Adverse Events, not the telephone calls. This is why the two Methylphenidate arms (MP+ NTI and MP+CTI) were combined into one arm and similarly the two Placebo arms were combined into one arm.	0.00% 0/50 • Adverse events measured up to 15 days Adverse Events data were presented in 2 arms. The reason is that only the Intervention medicine Methylphenidate (MP) can produce Adverse Events, not the telephone calls. This is why the two Methylphenidate arms (MP+ NTI and MP+CTI) were combined into one arm and similarly the two Placebo arms were combined into one arm.	0.00% 0/48 • Adverse events measured up to 15 days Adverse Events data were presented in 2 arms. The reason is that only the Intervention medicine Methylphenidate (MP) can produce Adverse Events, not the telephone calls. This is why the two Methylphenidate arms (MP+ NTI and MP+CTI) were combined into one arm and similarly the two Placebo arms were combined into one arm.

Additional Information

Dr. Eduardo Bruera, MD- Chair, Palliative Care Med

UT MD Anderson Cancer Center

Phone: (713) 792-6084

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place