Patient Controlled Methylphenidate for Cancer Related Fatigue: A Double Blind, Randomized, Placebo Controlled Trial
September 28, 2022 updated by: M.D. Anderson Cancer Center
To determine the effectiveness of patient controlled methylphenidate as compared to placebo for the management of cancer related fatigue as determined by the Functional Assessment of Chronic Illness Therapy (FACIT)-F Fatigue score.
Study Overview
Status
Completed
Intervention / Treatment
Detailed Description
Primary objective:
-To determine the effectiveness of patient controlled methylphenidate as compared to placebo for the management of cancer related fatigue as determined by the Functional Assessment of Chronic Illness Therapy (FACIT)-F Fatigue score
Secondary objective
- To assess the efficacy of as needed methylphenidate on pain, sedation and quality of life.
- To assess the potential side effects of methylphenidate on appetite, insomnia and anxiety
Study Type
Interventional
Enrollment (Actual)
112
Phase
- Phase 3
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Texas
-
Houston, Texas, United States, 77030
- M D Anderson Cancer Center
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Presence of fatigue on a numerical scale during the last 24 hours of more or equal to 4 on a 0 to 10 scale in which 0 equals no fatigue and 10 worst possible fatigue.
- Patients should describe fatigue as being present for a minimum of four days.
- If patients are on opioids for the treatment of cancer pain, change of opioids is allowed.
- No clinical evidence of cognitive failure, with normal Mini Mental State Examination (MMSE). A score of 24 is considered as normal.
- Sign written informed consent.
- Patients must be 18 years or older.
- Patient willing to keep a daily diary, engage in daily telephone follow up with a nurse, and after 7 days of treatment patient will return for a follow up visit.
- Patient must have telephone access to be contacted daily by the research nurse.
- Hemoglobin of >/=10 g/dl within 2 weeks of enrollment. If the patient has not had blood drawn for a hemoglobin level in the past two weeks, one will be done to determine the eligibility.
Exclusion Criteria:
- Major contraindication to methylphenidate i.e. hypersensitivity, anxiety, tension, agitation, or motor tics
- Currently on methylphenidate or has been on methylphenidate within the last 10 days.
- Inability to complete the baseline assessment forms or to understand the recommendations for participation in the study.
- Pregnant or lactating women.
- Patients taking MAO inhibitors, tricyclic antidepressants and clonidine.
- Patients with glaucoma, history of marked anxiety disorder, or history of substance abuse.
- CAGE questionnaire score for the last 2 years is 2 or above on a 0 to 4 scale
- History of Tourette's syndrome
- Patients with tachycardia and uncontrolled hypertension.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Single Group Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Methylphenidate
treatment of attention deficit disorder and narcolepsy (sleep disorder)
|
Given PO
Given PO
|
|
Experimental: Placebo
Sugar pill
|
Given PO
Given PO
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
To establish the effectiveness of patient the management of cancer related fatigue as determined by the Functional Assessment of Chronic Illness Therapy (FACIT)-F Fatigue score: 0-10 numerical scale.
Time Frame: through study completion, an average of 1 year
|
through study completion, an average of 1 year
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Eduardo Bruera, M.D. Anderson Cancer Center
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Helpful Links
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
July 16, 2003
Primary Completion (Actual)
December 15, 2004
Study Completion (Actual)
November 19, 2021
Study Registration Dates
First Submitted
September 3, 2021
First Submitted That Met QC Criteria
September 3, 2021
First Posted (Actual)
September 13, 2021
Study Record Updates
Last Update Posted (Actual)
September 29, 2022
Last Update Submitted That Met QC Criteria
September 28, 2022
Last Verified
September 1, 2022
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2003-0537
- NCI-2021-10777 (Other Identifier: NCI ID)
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Yes
Studies a U.S. FDA-regulated device product
No
product manufactured in and exported from the U.S.
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.