Advanced CancerPhase 2/3NCT00424099
Methylphenidate and a Nursing Telephone Intervention for Fatigue
A Phase 2/3 study testing Methylphenidate, Nursing Telephone Intervention and Non NTI in people with Advanced Cancer and Fatigue, run by M.D. Anderson Cancer Center at 2 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Advanced Cancer, Fatigue
- What is being tested?
- Methylphenidate, Nursing Telephone Intervention and Non NTI
- Type of treatment
- Pill or oral medicine, Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 197 participants
- Where
- 2 sitesUnited States
- Study dates
- 9 Jan 2007to 22 Nov 2021
- Phase
- Phase 2/3
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
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- 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.
Who cannot join
- 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
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- 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
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Lyndon Baines Johnson (LBJ) Hospital
Houston, Texas, 77026
University of Texas MD Anderson Cancer Center
Houston, Texas, 77030
About this study
Official title: A Randomized Controlled Trial of Methylphenidate and a Nursing Telephone Intervention (NTI) for Fatigue in Advanced Cancer Patients
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.
Read the 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.
- Conditions
- Advanced Cancer, Fatigue
- Being tested
- Methylphenidate, Nursing Telephone Intervention, Placebo, Non NTI
- Keywords
- Advanced Cancer, Fatigue, Nursing Telephone Intervention, NTI, Methylphenidate, Placebo, Ritalin
- Medical subject headings
- Fatigue
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MethylphenidateDrug
Also called Ritalin
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 InterventionBehavioural
Also called NTI
Call from study nurse 3 times weekly to ask about side effects and other symptoms.
PlaceboDrug
One capsule, orally every two hours as needed up to a maximum of 4 capsules per day for a period of 14 days.
Non NTIBehavioural
Also called Non Nursing Telephone Intervention
Non NTI are calls from research staff 3 times weekly.
| Study group | Role | What they receive |
|---|---|---|
| Group 1: Methylphenidate + NTI | Experimental | Methylphenidate 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. Receives: Drug: Methylphenidate; Behavioral: Nursing Telephone Intervention |
| Group 2: Placebo + NTI | Placebo comparator | Placebo capsule orally as needed for 14 days + NTI, calls from study nurse 3 times weekly to ask about side effects and other symptoms. Receives: Behavioral: Nursing Telephone Intervention; Drug: Placebo |
| Group 3: Methylphenidate + Non NTI | Experimental | Methylphenidate 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. Receives: Drug: Methylphenidate; Behavioral: Non NTI |
| Group 4: Placebo + Non NTI | Experimental | Placebo capsules as needed with Non NTI, calls from research staff 3 times weekly. Receives: Drug: Placebo; Behavioral: Non NTI |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline and Day 15
Secondary outcomes (1)
Change in Edmonton Symptom Assessment System (ESAS) Fatigue Score
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.
Measured: Baseline and Day 15
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jan 2007 (estimated)
- Study start9 Jan 2007
- Primary completion22 Nov 2021
- Study completion22 Nov 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Advanced CancerStudies of the same condition, open and under way.
- More trials run by M.D. Anderson Cancer CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2/3
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 197 participants (actual)
Sponsor and investigators
- Lead sponsor
- M.D. Anderson Cancer Center
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of Nursing Research (NINR)
- Responsible party
- Sponsor
- Investigators
- Eduardo Bruera, MD, Principal investigator, M.D. Anderson Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00424099
- Sponsor's protocol ID
- 2005-0613
- Other IDs
- R01NR010162-01A1, NCI-2012-01571
- Status last verified
- May 2023
- First submitted
- 16 Jan 2007
- Last updated
- 1 Jun 2023
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Publications
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.
PubMed 27148765Bruera 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.
PubMed 23690414
Study at a glance
From the registry record, last updated by the sponsor on 1 Jun 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Controlled Trial of Methylphenidate and a Nursing Telephone Intervention (NTI) for Fatigue in Advanced Cancer Patients
- ClinicalTrials.gov ID
- NCT00424099
- Acronym / sponsor ID
- 2005-0613
- Conditions
- Advanced Cancer, Fatigue
- Keywords
- Advanced Cancer, Fatigue, Nursing Telephone Intervention, NTI, Methylphenidate, Placebo, Ritalin
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 197 participants (actual)
- Lead sponsor
- M.D. Anderson Cancer CenterUniversity, hospital or other
- Collaborators
- National Institute of Nursing Research (NINR)
- Study start
- 9 Jan 2007 (actual)
- Primary completion
- 22 Nov 2021 (actual)
- Study completion
- 22 Nov 2021 (actual)
- First posted
- 18 Jan 2007 (estimated)
- Results
- Posted 1 Jun 2023
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Group 1: Methylphenidate + NTI | Experimental | Drug: Methylphenidate, Behavioral: Nursing Telephone InterventionMethylphenidate 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 comparator | Behavioral: Nursing Telephone Intervention, Drug: PlaceboPlacebo 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 | Experimental | Drug: Methylphenidate, Behavioral: Non NTIMethylphenidate 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 | Experimental | Drug: Placebo, Behavioral: Non NTIPlacebo capsules as needed with Non NTI, calls from research staff 3 times weekly. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- 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
Key exclusion criteria (13 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MethylphenidateAlso: Ritalin5 mg (one capsule) orally every two hours as needed up to a maximum of 20 mg per day for a period of 14 days. | Drug | Group 1: Methylphenidate + NTI, Group 3: Methylphenidate + Non NTI |
| Nursing Telephone InterventionAlso: NTICall from study nurse 3 times weekly to ask about side effects and other symptoms. | Behavioural | Group 1: Methylphenidate + NTI, Group 2: Placebo + NTI |
| PlaceboOne capsule, orally every two hours as needed up to a maximum of 4 capsules per day for a period of 14 days. | Drug | Group 2: Placebo + NTI, Group 4: Placebo + Non NTI |
| Non NTIAlso: Non Nursing Telephone InterventionNon NTI are calls from research staff 3 times weekly. | Behavioural | Group 3: Methylphenidate + Non NTI, Group 4: Placebo + Non NTI |
Primary outcome
Change in Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-F) Fatigue Subscale Score
Time frame: 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.
1 secondary outcome
Change in Edmonton Symptom Assessment System (ESAS) Fatigue Score
Time frame: Baseline and Day 15
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Jun 2023.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 27148765Yennurajalingam 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.
- Derived from this study: PubMed 23690414Bruera 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.
- UT MD Anderson Cancer Center Official WebsiteLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Eduardo Bruera, MD principal investigator
M.D. Anderson Cancer Center
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing Methylphenidate, Nursing Telephone Intervention and Non NTI in people with Advanced Cancer and Fatigue, run by M.D. Anderson Cancer Center at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 11 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 1 Jun 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 1 Jun 2023). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-F) Fatigue Subscale Score (time frame: Baseline and Day 15). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00424099, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Jun 2023.