Methylphenidate and a Nursing Telephone Intervention for Fatigue
A Randomized Controlled Trial of Methylphenidate and a Nursing Telephone Intervention (NTI) for Fatigue in Advanced Cancer Patients
3 other identifiers
interventional
197
1 country
2
Brief Summary
The goal of this clinical research study is to learn if methylphenidate (Ritalin) can help to control fatigue caused by cancer. Its effect on other symptoms such as drowsiness, depression, sleeplessness, physical activity, and anxiety will also be studied. Another goal of this study is to learn if receiving a phone call by a nurse improves fatigue in patients.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2
Started Jan 2007
Longer than P75 for phase_2
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 9, 2007
CompletedFirst Submitted
Initial submission to the registry
January 16, 2007
CompletedFirst Posted
Study publicly available on registry
January 18, 2007
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 22, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
November 22, 2021
CompletedResults Posted
Study results publicly available
June 1, 2023
CompletedJune 1, 2023
May 1, 2023
14.9 years
January 16, 2007
October 24, 2022
May 31, 2023
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Change in Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-F) Fatigue Subscale Score
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.
Baseline and Day 15
Secondary Outcomes (1)
Change in Edmonton Symptom Assessment System (ESAS) Fatigue Score
Baseline and Day 15
Study Arms (4)
Group 1: Methylphenidate + NTI
EXPERIMENTALMethylphenidate 5 mg (one capsule) orally every two hours as needed up to a maximum of 20 mg per day for a period of 14 days + Nursing Telephone Intervention (NTI). NTI calls from study nurse 3 times weekly to ask about side effects and other symptoms.
Group 2: Placebo + NTI
PLACEBO COMPARATORPlacebo capsule orally as needed for 14 days + NTI, calls from study nurse 3 times weekly to ask about side effects and other symptoms.
Group 3: Methylphenidate + Non NTI
EXPERIMENTALMethylphenidate 5 mg (one capsule) orally every two hours as needed up to a maximum of 20 mg per day for a period of 14 days + Non NTI, calls from research staff 3 times weekly.
Group 4: Placebo + Non NTI
EXPERIMENTALPlacebo capsules as needed with Non NTI, calls from research staff 3 times weekly.
Interventions
5 mg (one capsule) orally every two hours as needed up to a maximum of 20 mg per day for a period of 14 days.
Call from study nurse 3 times weekly to ask about side effects and other symptoms.
One capsule, orally every two hours as needed up to a maximum of 4 capsules per day for a period of 14 days.
Non NTI are calls from research staff 3 times weekly.
Eligibility Criteria
You may qualify if:
- Patients will be eligible to participate in this study if they have advanced cancer.
- Patients will be eligible to participate in this study if they rate fatigue on the Edmonton Symptom Assessment System (ESAS) during the last 24 hours as greater than or equal to 4 on a 0-10 scale, in which 0= no fatigue and 10=worst possible fatigue
- Describe fatigue as being present every day for most of day for a minimum of 2 weeks
- Lack clinical evidence of cognitive failure, with normal Mini Mental State Examination (MMSE). A score of 24 is considered normal
- Are 18 years or older
- Are willing to keep a daily diary, engage in telephone follow up with a nurse every other day, and return for follow-up visit after 14 days of treatment
- Have telephone access to be contacted by the research nurse. If patient is relocating within 5 weeks, patient will be asked to provide a new telephone number
- Hemoglobin of greater than or equal to 8 g/dl within 2 weeks of enrollment. If the patient has not had blood drawn for a hemoglobin level in the past 2 weeks, one will be done to determine the eligibility. Patients with a hemoglobin of less than 8 will be referred for treatment of their anemia
- Able to understand the description of the study and give written informed consent.
- Able to understand the description of assessments, and able to complete baseline assessment
- Patients on no erythropoietin or stable dose.
You may not qualify if:
- Major contraindication to methylphenidate i.e. hypersensitivity, anxiety, tension, agitation, or motor tics, glaucoma, severe angina pectoris, or hypertension, etc.
- Currently on methylphenidate or has been on methylphenidate within the last 10 days.
- Inability to complete the baseline assessment forms or do understand the recommendations for participation in the study
- Major depression according to the Structured Clinical Interview (SCID) Diagnostic and Statistical Manual of Mental Disorders (DSM) IV diagnostic criteria. These patients wil be referred immediately to psychiatry for assessment and management
- Pregnant or lactating women
- Requirement for Monoamine oxidase inhibitors (MAOIs), tricyclic antidepressants or clonidine
- Glaucoma, history of marked anxiety disorders
- History of alcohol (CAGE questionnaire score for the last 2 years is 2 or above on a 0 to 4 scale) or substance abuse including illegal drugs and/or medications.
- Tourette's syndrome
- Symptomatic tachycardia and uncontrolled hypertension.
- Currently receiving oral anticoagulants (Coumadin/warfarin), anticonvulsants (Phenobarbital, diphenylhydantoin, primidone), phenylbutazone, and tricyclic drugs (imipramine, clomipramine, desipramine).
- Patients with pacemakers
- Patients with symptomatic cardiac arrhythmias
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (2)
Lyndon Baines Johnson (LBJ) Hospital
Houston, Texas, 77026, United States
University of Texas MD Anderson Cancer Center
Houston, Texas, 77030, United States
Related Publications (2)
Yennurajalingam S, Tayjasanant S, Balachandran D, Padhye NS, Williams JL, Liu DD, Frisbee-Hume S, Bruera E. Association between Daytime Activity, Fatigue, Sleep, Anxiety, Depression, and Symptom Burden in Advanced Cancer Patients: A Preliminary Report. J Palliat Med. 2016 Aug;19(8):849-56. doi: 10.1089/jpm.2015.0276. Epub 2016 May 5.
PMID: 27148765DERIVEDBruera E, Yennurajalingam S, Palmer JL, Perez-Cruz PE, Frisbee-Hume S, Allo JA, Williams JL, Cohen MZ. Methylphenidate and/or a nursing telephone intervention for fatigue in patients with advanced cancer: a randomized, placebo-controlled, phase II trial. J Clin Oncol. 2013 Jul 1;31(19):2421-7. doi: 10.1200/JCO.2012.45.3696. Epub 2013 May 20.
PMID: 23690414DERIVED
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Dr. Eduardo Bruera, MD- Chair, Palliative Care Med
- Organization
- UT MD Anderson Cancer Center
Study Officials
- PRINCIPAL INVESTIGATOR
Eduardo Bruera, MD
M.D. Anderson Cancer Center
Publication Agreements
- PI is Sponsor Employee
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- SUPPORTIVE CARE
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
January 16, 2007
First Posted
January 18, 2007
Study Start
January 9, 2007
Primary Completion
November 22, 2021
Study Completion
November 22, 2021
Last Updated
June 1, 2023
Results First Posted
June 1, 2023
Record last verified: 2023-05