Trial · NCT00424099
Methylphenidate and a Nursing Telephone Intervention for Fatigue
NCT00424099, Phase 2, Phase 3, Completed, M.D. Anderson Cancer Center; results first posted 2023-06-01
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Methylphenidate and a Nursing Telephone Intervention for Fatigue. Trials, record NCT00424099. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00424099
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Methylphenidate and a Nursing Telephone Intervention for Fatigue
- NCT number
- NCT00424099
- Status
- Completed
- Phases
- Phase 2, Phase 3
- Enrollment
- 197 participants, actual
- Lead sponsor
- M.D. Anderson Cancer Center
- Conditions
- Advanced Cancer, Fatigue
- Interventions
- Methylphenidate, Nursing Telephone Intervention, Placebo, Non NTI
- First posted
- 2007-01-18
- Last updated
- 2023-06-01
- Results first posted
- 2023-06-01
Source ClinicalTrials.gov
Registered outcomes2
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Change in Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-F) Fatigue Subscale Score | Baseline and Day 15 | 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. |
| Secondary | Change in Edmonton Symptom Assessment System (ESAS) Fatigue Score | 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. |
Source ClinicalTrials.gov
Outcomes2
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Change in Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-F) Fatigue Subscale Score | Baseline and Day 15 | Those who completed intervention up to day 15 | score on a scale | MEDIAN |
| SECONDARY | Change in Edmonton Symptom Assessment System (ESAS) Fatigue Score | Baseline and Day 15 | score on a scale | MEDIAN |
Source ClinicalTrials.gov
Results by group8
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Change in Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-F) Fatigue Subscale Score | Methylphenidate (MP) + Nursing Telephone Intervention (NTI) | 4.00 | Inter-Quartile Range -2.00 to 11.0 | score on a scale | |
| Change in Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-F) Fatigue Subscale Score | Methylphenidate (MP) + Control Telephone Intervention (CTI) | 7.00 | Inter-Quartile Range 2.00 to 11.00 | score on a scale | |
| Change in Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-F) Fatigue Subscale Score | Placebo (PL)+ Nursing Telephone Intervention (NTI) | 8.50 | Inter-Quartile Range 3.00 to 17.00 | score on a scale | |
| Change in Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-F) Fatigue Subscale Score | Placebo (PL) + Control Telephone Intervention (CTI) | 5.00 | Inter-Quartile Range 0.00 to 6.00 | score on a scale | |
| Change in Edmonton Symptom Assessment System (ESAS) Fatigue Score | Methylphenidate (MP) + Nursing Telephone Intervention (NTI) | -3.00 | Inter-Quartile Range -4.00 to -1.00 | score on a scale | |
| Change in Edmonton Symptom Assessment System (ESAS) Fatigue Score | Methylphenidate (MP) + Control Telephone Intervention (CTI) | -1.00 | Inter-Quartile Range -3.00 to 0 | score on a scale | |
| Change in Edmonton Symptom Assessment System (ESAS) Fatigue Score | Placebo (PL)+ Nursing Telephone Intervention (NTI) | -2.00 | Inter-Quartile Range -5.00 to 0 | score on a scale | |
| Change in Edmonton Symptom Assessment System (ESAS) Fatigue Score | Placebo (PL) + Control Telephone Intervention (CTI) | -2.00 | Inter-Quartile Range -4.00 to 0 | score on a scale |
Source ClinicalTrials.gov
Participant flow12
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Methylphenidate (MP) + Nursing Telephone Intervention (NTI) | 45 | |
| Overall Study | STARTED | Methylphenidate (MP) + Control Telephone Intervention (CTI) | 47 | |
| Overall Study | STARTED | Placebo (PL)+ Nursing Telephone Intervention (NTI) | 50 | |
| Overall Study | STARTED | Placebo (PL) + Control Telephone Intervention (CTI) | 48 | |
| Overall Study | COMPLETED | Methylphenidate (MP) + Nursing Telephone Intervention (NTI) | 38 | |
| Overall Study | COMPLETED | Methylphenidate (MP) + Control Telephone Intervention (CTI) | 31 | |
| Overall Study | COMPLETED | Placebo (PL)+ Nursing Telephone Intervention (NTI) | 38 | |
| Overall Study | COMPLETED | Placebo (PL) + Control Telephone Intervention (CTI) | 35 | |
| Overall Study | NOT COMPLETED | Methylphenidate (MP) + Nursing Telephone Intervention (NTI) | 7 | |
| Overall Study | NOT COMPLETED | Methylphenidate (MP) + Control Telephone Intervention (CTI) | 16 |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 participant flowAdverse events40
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Pain | Nervous system disorders | Methylphenidate (MP) +Nursing Telephone Intervention (NTI) | 2 | 45 | |
| other | Pain | Nervous system disorders | Methylphenidate (MP) +Control Telephone Intervention (CTI) | 1 | 47 | |
| other | Pain | Nervous system disorders | Placebo (PL)+ Nursing Telephone Intervention (NTI) | 2 | 50 | |
| other | Pain | Nervous system disorders | Placebo (PL) + Control Telephone Intervention (CTI) | 1 | 48 | |
| other | Insomnia | Nervous system disorders | Methylphenidate (MP) +Nursing Telephone Intervention (NTI) | 3 | 45 | |
| other | Insomnia | Nervous system disorders | Methylphenidate (MP) +Control Telephone Intervention (CTI) | 0 | 47 | |
| other | Insomnia | Nervous system disorders | Placebo (PL)+ Nursing Telephone Intervention (NTI) | 1 | 50 | |
| other | Insomnia | Nervous system disorders | Placebo (PL) + Control Telephone Intervention (CTI) | 3 | 48 | |
| other | Mood Alteration | Psychiatric disorders | Methylphenidate (MP) +Nursing Telephone Intervention (NTI) | 1 | 45 | |
| other | Mood Alteration | Psychiatric disorders | Methylphenidate (MP) +Control Telephone Intervention (CTI) | 1 | 47 |
1 to 10 of 40Source ClinicalTrials.gov
See all 40 adverse eventsAdverse event totals12
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Methylphenidate (MP) +Nursing Telephone Intervention (NTI) | 0 | 45 |
| Total, all-cause mortality | Methylphenidate (MP) +Control Telephone Intervention (CTI) | 1 | 47 |
| Total, all-cause mortality | Placebo (PL)+ Nursing Telephone Intervention (NTI) | 0 | 50 |
| Total, all-cause mortality | Placebo (PL) + Control Telephone Intervention (CTI) | 0 | 48 |
| Total, other adverse events | Methylphenidate (MP) +Nursing Telephone Intervention (NTI) | 9 | 45 |
| Total, other adverse events | Methylphenidate (MP) +Control Telephone Intervention (CTI) | 4 | 47 |
| Total, other adverse events | Placebo (PL)+ Nursing Telephone Intervention (NTI) | 4 | 50 |
| Total, other adverse events | Placebo (PL) + Control Telephone Intervention (CTI) | 9 | 48 |
| Total, serious adverse events | Methylphenidate (MP) +Nursing Telephone Intervention (NTI) | 0 | 45 |
| Total, serious adverse events | Methylphenidate (MP) +Control Telephone Intervention (CTI) | 0 | 47 |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 adverse event totalsPapers2
The papers the trial lists on ClinicalTrials.gov.
Grants1
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
| Project | Title | Principal investigators | Organization | Funder | Fiscal years |
|---|---|---|---|---|---|
| R01NR010162 | Methylphenidate for Fatigue in Advanced Cancer Patients | BRUERA, EDUARDO | UNIVERSITY OF TX MD ANDERSON CAN CTR | NATIONAL INSTITUTE OF NURSING RESEARCH | 2006 to 2009 |
Source NIH RePORTER
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT00424099
GET https://conductscience.org/api/trials/v1/NCT00424099/events?page=2