Ignite Creation Date:
2024-05-05 @ 5:18 PM
Last Modification Date:
2024-10-26 @ 9:30 AM
Study NCT ID:
NCT00424099
Status:
COMPLETED
Last Update Posted:
2023-06-01
First Post:
2007-01-16
Brief Title:
Methylphenidate and a Nursing Telephone Intervention for Fatigue
Sponsor:
MD Anderson Cancer Center
Organization:
MD Anderson Cancer Center
Study Overview
Official Title:
A Randomized Controlled Trial of Methylphenidate and a Nursing Telephone Intervention NTI for Fatigue in Advanced Cancer Patients
Status:
COMPLETED
Status Verified Date:
2023-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
Detailed Description:
Fatigue is one of the most common problems in patients with advanced cancer Currently there are no treatments for managing fatigue Methylphenidate is a stimulant that increases ability to pay attention increases mental alertness and decreases feelings of fatigue
If you are found to be eligible to take part in this study you will be randomly assigned as in the roll of dice to one of 4 groups You will have an equal chance of being placed in any of the 4 groups You the medical staff and researchers will not know to which group you have been assigned
Regardless of which group you are in you will record your fatigue in a daily diary at breakfast lunch dinner and before bedtime Based on your level of fatigue you will take the study drug as needed You can take the study drug every 2 hours but you may not take more than 4 capsules a day
Participants in Group 1 will take a methylphenidate capsule by mouth as needed to relieve symptoms of fatigue for 14 days A nurse will call you 4-6 times in the first two weeks to ask about side effects and other symptoms The phone calls should take about 10-20 minutes The study nurse will set up a convenient time for you to take the phone call
Participants in Group 2 will take a placebo capsule by mouth as needed for 14 days A placebo is a capsule that does not contain any medication but looks just like the methylphenidate A nurse will call you 4-6 times in the first two weeks to ask about side effects and other symptoms The phone calls should take about 10-20 minutes The study nurse will set up a convenient time for you to take the phone call
Participants in Group 3 will take a methylphenidate capsule by mouth as needed for 14 days Participants in this group will not receive any calls from a study nurse However A research staff member will call you 4-6 times in the first two weeks to ask about side effects and other symptoms The phone calls should take about 10-20 minutes The research staff member will set up a convenient time for you to take the phone call
Participants in Group 4 will take a placebo capsule by mouth as needed for 14 days Participants in this group will not receive any calls from a study nurse However A research staff member will call you 4-6 times in the first two weeks to ask about side effects and other symptoms The phone calls should take about 10-20 minutes The research staff member will set up a convenient time for you to take the phone call
You will be asked to wear a wrist actigraph monitor a wristwatch that keeps track of your physical activity and your sleep cycles for the first 14 days
You will keep a daily diary of your fatigue and other symptoms the number and times pills are taken and your fatigue rating before and 2 hours after taking methylphenidate
On about day 15 or within 3 days you will return to the palliative care clinic at M D Anderson for tests You will be asked about your level of drowsiness pain constipation and fatigue You will be asked about any side effects you may have experienced and the effectiveness of the drug You will repeat the 6 minute physical test the cognitive status test and you will return the actigraph monitor to the research nurse You will also be given the option to receive up to 4 capsules of methylphenidate per day until Day 36 You will not be told whether you were taking placebo or methylphenidate during Days 1-14 If you cannot come to the clinic on Day 15 all tests except the walking test may be performed over the telephone You will be asked to mail the actigraph back
If you decide not to take methylphenidate on Days 15-36 you will be considered off-study and you will have end-of-study tests on Day 15 If you decide to take methylphenidate on Days 15-36 you will remain on study until Day 36 On Day 36 you will have end-of-study tests
For end-of-study tests you will repeat the physical and cognitive tests You will be asked about your symptoms and any side effects you may be experiencing You will then return to your primary physician who will discuss with you whether or not to continue on the methylphenidate based on your response to the drug
Your participation in this study should end on either Day 15 or Day 36 However if you develop intolerable side effects including fatigue while on this study the medication will be stopped and you will be removed from the study
This is an investigational study Methylphenidate has been approved by the FDA and is a commercially available drug It is FDA approved at this dose level Its use in this study for this purpose is investigational About 212 patients will take part in this multicenter study About 142 patients will be enrolled at The University of Texas UT MD Anderson
If you are found to be eligible to take part in this study you will be randomly assigned as in the roll of dice to one of 4 groups You will have an equal chance of being placed in any of the 4 groups You the medical staff and researchers will not know to which group you have been assigned
Regardless of which group you are in you will record your fatigue in a daily diary at breakfast lunch dinner and before bedtime Based on your level of fatigue you will take the study drug as needed You can take the study drug every 2 hours but you may not take more than 4 capsules a day
Participants in Group 1 will take a methylphenidate capsule by mouth as needed to relieve symptoms of fatigue for 14 days A nurse will call you 4-6 times in the first two weeks to ask about side effects and other symptoms The phone calls should take about 10-20 minutes The study nurse will set up a convenient time for you to take the phone call
Participants in Group 2 will take a placebo capsule by mouth as needed for 14 days A placebo is a capsule that does not contain any medication but looks just like the methylphenidate A nurse will call you 4-6 times in the first two weeks to ask about side effects and other symptoms The phone calls should take about 10-20 minutes The study nurse will set up a convenient time for you to take the phone call
Participants in Group 3 will take a methylphenidate capsule by mouth as needed for 14 days Participants in this group will not receive any calls from a study nurse However A research staff member will call you 4-6 times in the first two weeks to ask about side effects and other symptoms The phone calls should take about 10-20 minutes The research staff member will set up a convenient time for you to take the phone call
Participants in Group 4 will take a placebo capsule by mouth as needed for 14 days Participants in this group will not receive any calls from a study nurse However A research staff member will call you 4-6 times in the first two weeks to ask about side effects and other symptoms The phone calls should take about 10-20 minutes The research staff member will set up a convenient time for you to take the phone call
You will be asked to wear a wrist actigraph monitor a wristwatch that keeps track of your physical activity and your sleep cycles for the first 14 days
You will keep a daily diary of your fatigue and other symptoms the number and times pills are taken and your fatigue rating before and 2 hours after taking methylphenidate
On about day 15 or within 3 days you will return to the palliative care clinic at M D Anderson for tests You will be asked about your level of drowsiness pain constipation and fatigue You will be asked about any side effects you may have experienced and the effectiveness of the drug You will repeat the 6 minute physical test the cognitive status test and you will return the actigraph monitor to the research nurse You will also be given the option to receive up to 4 capsules of methylphenidate per day until Day 36 You will not be told whether you were taking placebo or methylphenidate during Days 1-14 If you cannot come to the clinic on Day 15 all tests except the walking test may be performed over the telephone You will be asked to mail the actigraph back
If you decide not to take methylphenidate on Days 15-36 you will be considered off-study and you will have end-of-study tests on Day 15 If you decide to take methylphenidate on Days 15-36 you will remain on study until Day 36 On Day 36 you will have end-of-study tests
For end-of-study tests you will repeat the physical and cognitive tests You will be asked about your symptoms and any side effects you may be experiencing You will then return to your primary physician who will discuss with you whether or not to continue on the methylphenidate based on your response to the drug
Your participation in this study should end on either Day 15 or Day 36 However if you develop intolerable side effects including fatigue while on this study the medication will be stopped and you will be removed from the study
This is an investigational study Methylphenidate has been approved by the FDA and is a commercially available drug It is FDA approved at this dose level Its use in this study for this purpose is investigational About 212 patients will take part in this multicenter study About 142 patients will be enrolled at The University of Texas UT MD Anderson
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| NCI-2012-01571 | REGISTRY | NCI-CTRP | httpsreporternihgovquickSearchR01NR010162-01A1 |
| R01NR010162-01A1 | NIH | None | None |